Care Giving Regulatory Affairs

Dr Sucharita Das (Victoria)

****E Windrose Drive Scottsdale AZ 85260, USA

Cell: 480-***-****

Email: *********@*****.***.**

Over 22 years of experience in Global (26 countries) regulatory affairs strategy, intelligence, submissions, due diligence, and early market penetration/prioritization within multinational companies such as Abbot/Hospira, Pfizer, Allergan etc. Experienced in global senior leadership positions in US and European multinationals in pharmaceuticals (Small molecules), Biologics (Large molecules), NDAs/ANDAs, 505 b(1&2), 21CFR 820, 2170, part 803, 361, OTC, generics, medical device (Class 1 to 3), cosmetics, Cell/gene and consumer products (health food, VMS, TCM), manufacturing and distribution at a global level. An international invited speaker and advisor in global health care conferences. With 12 years of GCP global site audits Phase 1 to Phase 3, GMP, GDP GPV, GDPMDS, GTP mock, internal as well as ethical and supplier audits.

18 years of strong ICH modules 2/3 (CMC), module 4 (Preclinical) and Module 5 (Clinical) hands on experience in small and large molecules and eCTD submissions to global health authorities e.g., USFDA, PMDA, MHRA, HSA, NMPA, MFDS etc.

Possesses strategic enterprise thinking and strong leadership skills (managed largest team size of 620 staff) that aligns organizational goals and aspirations to oversee the strategic, operational activities and implementation of all strategic initiatives related to regulatory, quality and compliance. Has a successful track record such as providing training to employees, reduction in recalls by 50% and SQEs by 60% at 25 manufacturing sites, registered more than 500 products globally, completed more than 600 audits globally, reduction of complaints by 50% and brought about approvals of more than 200 WIs and SOPS. An experienced expert in CMC technical writing, non-clinical and clinical for drugs/devices and Cell/Gene therapy.

EDUCATION HISTORY

PhD in Business and management, University of South Australia

MBA, University of Leicester UK

BSc, Pharmacy, National University of Singapore, (Singapore Registered Pharmacist)

Contract law, Harvard University US

CORE COMPETENCIES

Leadership competencies

·Motivational and Visionary leader. Managed a team ranging from 6 to 18 directors/senior managers with a collective team size of 620 in a matrix environment

·Demonstrates strategic enterprise thinking to find innovative ways to serve patients, and build trust, reputation, and business

·Handled five Joint Ventures, Mergers and Acquisitions managing transition periods, restructuring, moving of regional offices, new team startups and Organizational design. Managed union and non-union facilities; Contracts and Agreements negotiations in terms of policy, process, and pricing.

·Creates the environment that inspires and enables people to move the organization forward Elevate the capabilities of the organization for now and the future

·Adept at directing, leading, executing, and operationalizing relevant initiatives to address potential regulatory, quality or compliance issues at a global or regional level that raised the organizations readiness to respond effectively to external guidelines and regulations.

·Excellent organizational and interpersonal skills with the ability to build organizational capabilities through leading, motivating, inspiring, mentoring and coaching cross functional and cross regional teams to deliver results in a matrix organization.

·Led cross-functional and cross regional teams and delivered results in a matrix organization. Excellent organizational and project management skills, ability to prioritise- manage both time, priority constraints and to manage multiple priorities simultaneously.

·Practical operational experience of working across disciplines and across multiple regions. Experience working within a global team framework and a multi-cultural environment. Efficiently/actively managed conflict in a tactful, diplomatic way, seeking effective solutions for all parties.

·Excellent analytical, technical, and problem-solving skills. Capable to critically analyse complex and/or ambiguous information and the impact on products and process. and to effectively communicate complex issues both verbally and in writing.

·Trained staff to obtain 6 Sigma green/ black belts; managed IDPs

Technical competencies

·Strong experiences and expertise in managing manufacturing quality operations and EHS to be able to effectively be strategized and managed all challenges pertaining to compliance, audits and cGMP/GCP.

·Strong technical capabilities not limited to GxP audit and compliance and all related audits with the capabilities to conduct third party supplier and OEMs audits to ensure compliance in cGMP, cGCP, GLP, GQP, ISO 13485, GDP and GDPMDS audits at a global/APAC level.

·Strong regulatory intelligence, strategy, and hands on experience in global/APAC health care products regulations (i.e., US FDA, HSA, PMDA, TGA, MHRA, DCG etc.), conducted Regulatory due diligences, abided by advertising, promotions, labelling guidelines and industry standards to ensure local country and corporate compliance.

·Strong knowledge and expertise in medical affairs to be able to formulate publications plans, and the reporting of pivotal trial results to the Health Authorities, at scientific meetings and through journal article. Ensured that consumer questions are addressed and provided informational services to health care providers.

·Expertise in Clinical Trials/New product development from Phase 1 to Phase 4. Covered therapeutic areas such as oncology (breast, prostate, ovarian, colorectal, NSCLC etc), Cardiovascular, neurology, nephrology, ophthalmology and endocrinology.

·Practical operational experience of working across disciplines. Efficiently/actively managed conflict in a tactful, diplomatic way, seeking effective solutions for all parties.

·Excellent analytical, technical and problem-solving skills. Capable to critically analyse complex and/or ambiguous information and the impact on products and process and to effectively communicate complex issues both verbally and in writing.

KEY ACHIEVEMENTS

Clinical Trial

Provided sponsor quality oversight of clinical development activities for regional development programs, ensured that investigator, supplier, and facility/ system audits are conducted, communicating any critical compliance risks noted from these activities, and ensuring that corrective actions are implemented.

Served as a strategic GCP resource for drug development activities Phase 1 to Phase 3, and taken a lead role for the preparation, conduct, and responses to health authority inspections and queries. Ensured trials are conducted in compliance with Good Clinical Practice (GCP) regulations, the International Conference on Harmonization (ICH) and local health authority requirements.

Prepared Pre IND submission packages and Investigational Brochures at a global level.

Worked closely with medical affairs team on clinical trial protocol as well as Investigational Brochure drafting, review, and updates.

Regulatory

Successfully registered 20 OTCs (200 regionally), 50 generic drugs (500 regionally), 25 NCEs /NDAs (500 regionally), 2 Biologics (40 regionally), 500 medical devices and managed more than a thousand variation applications in US, EU, Latin America, and APAC.

Developed long term and short term global regulatory strategies.

Made complex decisions and defended difficult positions in Regulatory and Compliance with high level negotiations and direct interactions with regulatory authorities (e.g., FDA, PMDA, NMPA, TGA, EMA etc).

Successfully created regulatory strategies for APAC, NFM, Latin America, US, EU markets for Pharmaceuticals, OTC, TCMs, Functional food with claims, Devices (Class1,2 and 3) and cosmetics.

Provided CMC/Non-Clinical and Clinical protocol technical regulatory writing for drug/device/HCT/p submissions Module 2/3/4/5 according to ICH guidelines

Successfully provided regulatory Strategy and worked closely with USFDA/ PMDA/TFDA/MHRA/EMEA etc for BLA (Biologics License application) approvals (eg products; BOTOX, VACCINES and Intra articular injection for Osteoarthritis), NDAs and ANDAs. Successfully launched products through expedited review programs with the USAFDA and other global health authorities such as TGA, PMDA, HAS, Health Canada through Project Orbis and other Expedited review programs such as Priority review, RMAT, Accelerated Approval, Fast track and Breakthrough Therapy for drugs and biologics with unmet needs.

Led and conducted high level negotiations and discussions with FDA CBER team on Biologics submission and approvals.

Worked closely with medical affairs team on clinical trial protocol as well as Investigational Brochure drafting, review, and updates.

Globally registering small molecules and large molecules NDA, ANDA, 505b1 and 505b2, 21CFR 820, 2170, part 803, 361, IND/CTA, post marketing activities including labelling changes and adverse events reporting with USFDA, TGA, NMPA, HSA, TFDA etc.

Prepared Modules 1,2,3, (CMC) 4 (preclinical) and 5 (Clinical) for eCTD publishing and submissions according to ICH guidelines/Format and ACTD format.

Managed submissions of Annual Reports, labelling updates and developed country and region specific labelling strategies and archive all regulatory documentation etc.

Managed full product lifecycles from the design phase to Phase 3 and attain premarket authorization. Developed Clinical study protocols and facilitated setting up and interactions with clinical sites. Prepared IB.

Worked closely with BU to provide Regulatory intelligence, early market penetration strategy, regulatory submission strategy and market prioritization.

Had successful high-level interactions with Global Health Authorities e.g., USFDA, NMPA, HSA on Pre IND and submission queries and resolutions.

Covered therapeutic areas such as neurology, oncology, ophthalmology, hepatitis/liver cirrhosis and hematology.

Quality

Successfully conducted 500 ethical and quality GXP audits (GMP,GCP,GTP,GLP,GDP,GPV,GDPMDS,ISO 13485/9001, ISO 14971, IEC 60601 and 21 CFR 820) on third party manufacturers.

Developed and supported inspection readiness at 25 manufacturing and laboratory sites within the Global/APAC region, to achieve successful results with minimal observations during regulatory inspections (e.g., USFDA, TGA, MHRA, PMDA, HAS, BSI, TUV) for in house manufactured products

Created and implemented SOPs/policies such ADProms compliance, E-archiving, PV reporting Compliance, FSCA, safety, Software validation reports etc.

Proactively reduced Severe Quality Events by 60% at 25 manufacturing sites by working closely with procurement, regulatory, Safety, R&D and operations in improving mill processes e.g., installing vision cameras, training in SOPs/WIs.

CAREER HISTORY

CONSULTANT Sept 2019 to present

Regulatory Affairs, Quality Assurance and Compliance

Pharmaceuticals, Medical device and Cell/Gene therapies

GCP, GMP, GDP, GTP, GDPMDS, ISO 13485, GLP, GPV, IND, NDA, ANDA

Small molecules, Biologics, Medical Device,IVD, Consumer

Recent Projects:

1) Surgenex LLC (Based in USA, ARIZONA) Apr2021 – Oct2022

Global Director Regulatory, Quality and Compliance

Managed a team of 8 direct reports

Manage regulatory activities for biologics, IND, NDA, 361, 505b 1,2, 21CFR 1271, Class 1 and 2 HCT/Ps, Medical devices, 510K, 21 CFR 803, CTA/ filings, safety reporting to USFDA and international health authorities etc.

Have high level direct negotiations/advisory meetings and pre-IND meetings with USFDA and worked on Fast Track, breakthrough and RMAT, ESG set up, eCTD submissions

Led and conducted high level negotiations and discussions with CBER team on Biologics submission and approvals

Worked closely with medical affairs team on clinical trial protocol as well as Investigational Brochure drafting, review and updates.

Prepared the PRE IND Submission package and conducted gap analysis completion on feedback from CBER

Conducted GCP/GMP/GTP supplier, ethical and clinical quality audits for pharmaceuticals, devices and HCTps clinical sites. Managed annual reports, Investigator brochures, CSR, clinical quality processes, Clinical quality measures/indicators in safety and efficacy, batch records, labelling (CCDS), clinical journal manuscripts, abstracts review and presentations etc.

Provide training, set ups, ensure regulatory and quality strategy, risk/benefit analysis and compliance with cGMP, cGCP, GLP, GDP, GTP, clean rooms, ISO 13485, aseptic and software validations. Advertisement/promotions (OPDP/FCPA/DTC regulations etc.), QMS, complaints, quality technical agreements, Deviations, CAPA, Batch records, contracts, best practices, etc.

CMC /Non-Clinical and Clinical protocol technical regulatory writing for submissions Module 2/3/4/5 according to ICH/FDA guidelines.

Provide leadership, cross-functional strategic, operational support and manage budget

Responsible for interactions with health authorities, maintenance of registrations/licenses/accreditations and development of regulatory policies with AATB, ARM etc.

Expanded business at an international level. Manage queries and letters to medical practitioners, health authorities and consumers.

Audited third party manufacturers and suppliers, create quality culture/mindset and conducted software validations.

Ensure successful company manufacturing FDA/health authority site audits with minimal observations by health authorities.

Perform in depth reviews and approvals of labeling, submission documents, renewals and variation applications. Developed country and region-specific labelling strategies and archived all regulatory documentation etc.

2.Advisor with Dialectica (London, UK)

oon Business strategy, merger, and organization restructuring

3.Consultancy with US MNC (based in Atlanta)

oMedical device/Pharmaceuticals-on Quality, Regulatory, Legal and Compliance. Handling Severe quality events, CAPAS, Deviations, Right first time RFTs, labelling compliance, quality culture.

o19 manufacturing sites with 620 team size and budget of 80 million

4.Advisor with Guidepoint (US, New York)

oRegulatory and quality product lifecycle strategies

oCMC gap analysis, clinical trial quality and regulatory oversight for Medical devices Class 1 to 3, Companion Diagnostics/Biomarkers and Pharmaceuticals.

5.Advisor with Alphasights (San Francisco)

oAPAC Drug regulatory and quality challenges for medical device Class 1 to 3.

6.Consultancy with Atheneum (US, New York)

oon US FDA regulatory and quality project Orbis (Oncology Orphan drugs)

oSuccessfully provided regulatory Strategy to launch products through expedited review programs with the USAFDA and other global health authorities such as TGA, PMDA, HAS, Health Canada through Project Orbis and other Expedited review programs such as Priority review, RMAT, Accelerated Approval, Fast track and Breakthrough Therapy for drugs and biologics/oncology with unmet needs.

7.Consultancy with Arqon Global (Singapore)

opharma div on small molecules drug regulatory, clinical trial, Clinical Quality and Quality assurance challenges, renewals, variation applications,

o505 b 1,2, ANDA, NDA, CMC gap analysis, product license transfer

8.Consultancy Graphite/Advarra/RegAsk (USA, EAST COAST)

oConversion of OTC to pharma, Gap analysis in medical devices (Class 2 and 3), 510K submissions and pharmaceutical/biologics dossiers, food product registrations, Pre IND and IND submissions, CMC, preclinical and clinical gap analysis, review and labelling support.

Walgreens Boots Alliance Jul 2018 – Aug 2019

Senior Director Regulatory Affairs and Compliance APAC (Based in Hong Kong)

Key Accountabilities:

Managed 8 direct reporting regional staff to drive regulatory, quality assurance and compliance across Asia Pacific including 25 manufacturing sites (third party and own).

Oversaw all product registrations, renewals, variations approvals, early market access, negotiations with health authorities; QMS, Training, Complaints handling, QMS/ Ethical GXP audits; PV reporting Ensured up to date regulatory intelligence are set up and renewed for team within region. Shared and implemented any changes in regulations within region with corporate RA/QA and R&D.

Conducted ethical and quality GXP audits (GMP,GCP,GTP,GLP,GDP,GPV,GDPMDS,ISO 13485/9001, ISO 14971, IEC 60601 and 21 CFR 820) on third party manufacturers.

Responsible for overseeing the strategic, operational activities and implementation of global QMS department within Global Regulatory Affairs and Local Operating Company (LOC) Regulatory Affairs representatives.

Ensured Sustainability and Animal testing is minimized in products sold.

Successfully created regulatory strategies for APAC/ NFM markets for Pharmaceuticals, OTC, TCMs, Functional food with claims, Medical Devices (Class1, 2 and 3) and cosmetics.

Managed the communication, structure and implementation of GRA processes, systems and procedures for GxP processes (e.g., training, change control, deviations/CAPAs, etc.) within the region / LOC, ensuring execution and compliance.

Drove a quality culture of continuous improvement and ethical activities

Pfizer Inc Jun 2014 – Dec 2016

Regional Director of Quality Assurance and compliance APAC/Global (Based in Shanghai/Osaka)

Key accountabilities:

Managed a team of 18; created QMS and WIs, liaisons with APAC and Global manufacturing sites, Audits, Recalls, Warning letters, Complaints, Recalls, FSCA, Training, labelling compliance

Worked on injectables/vaccines, oral preparations and medical devices.

Led Quality Council and Proactively reduced Severe Quality Events by working closely with procurement, regulatory Safety, RE and operations in improving mill processes e.g., installing vision cameras, training in SOPs/WIs

Achieved Successful Lab & Tester Certifications for QA team and sites

Achieved great efficiency in establishing and monitoring Quality programs, policies and procedures to ensure compliance with health authority standards and corporate requirements and meet the needs of all internal and external stakeholders with an emphasis on processes, productivity, cost management and profitability.

Provided effective compliance and risk reporting to senior management across R&D and supports strategic QA governance forums

Reported quality related risks and compliance gaps to Global Audit Committee, senior management and across the R&D functions.

Oversaw the development and execution of inspection readiness activities for GRA processes within the region / LOCs and successfully managed, coordinated, and followed up on audits and inspections related to Regulatory Affairs processes globally within the regions / LOCs as well as ensured all regulatory authority audits, inspections and corrective action programs in response to observations.

Successfully managed all regulatory authority audits, inspections and corrective action programs in response to observations.

Successfully developed annual quality plans and executed Quality strategy aligned with the overall plan and strategies of BU to meet customer needs

Achieved Highly successful audits through personal oversight of successful creation of SOPs with zero observations received from BSI on our QMS, GMP and ISO13485 compliance.

Created a new product introduction SOP with flow chart to ensure greater teamwork among Marketing, R&D, QA, RA, Operations, procurement and safety personnel for every new product to be launched

Created a Quality culture and Quality mindset across all manufacturing sites

Covance Inc. Nov 2009 – May 2014

Regional Director Regulatory Affairs Strategy and compliance APAC/Global (Based in Singapore)

Key accountabilities:

Managed a team of 30 staff in Asia Pacific to drive regulatory strategy.

Oversaw the regulatory submissions and renewals of IND/CTAs,505b (1,2) and FPs for small molecules and large molecules. Provided Phase 1 to Phase 3 clinical trial strategy support including CMC, Preclinical and clinical write up according to ICH Modules1,2, 3, 4 and 5.

Worked closely with medical affairs team on the design protocols for oncology (breast cancer, NSCLC etc), Biomarkers etc.

Successfully led and collaborated with R&D Quality, Global Quality, R&D operational functions, Commercial, legal, finance, Supply chain, Regulatory, product development team and suppliers of outsourced services to ensure that clinical trial activities are conducted in compliance with Good Clinical Practice (GCP) regulations, the International Conference on Harmonization (ICH) and corporate requirements.

Provided R&D team with strategic Quality support, diligence and oversight using tools to functional and therapeutic areas, submission excellence activities, inspection readiness and risk assessment.

Prepared Pre IND submission packages and Investigational Brochures at a global level.

Worked closely with medical affairs team on clinical trial protocol as well as Investigational Brochure drafting, review and updates.

Nobel Biocare Holdings AG (Medical Devices) Mar 2004 – Nov 2009

Regional Director Regulatory /QA/ Medical Affairs (APAC/Global) (Based in HK/Singapore)

Key accountabilities:

Managed 6 manufacturing sites/ labs across APAC with a team of 32 staff to manage entire product life cycle; registrations and renewals, variations approvals, early market access; Negotiations with health authorities; CSDT/GHTF, QMS, Training, Complaints handling, Supplier/HA/Ethical audits; advertisement and labelling compliance, PV reporting

Worked closely with R&D on product development phase to ensure all product testing meet Global/APAC regulatory requirements

Ensured QMS and trainings meet WHO standards and all major health authority regulations at a global level

Contributed to the idea on classifications during brainstorming with HA which helped organization in creating the submission dossier

Allergan (Pharmaceuticals/Biologics and Medical Devices products) Jan 1997- March 2004

Senior Regional Manager (Regulatory Affairs, QA, CT) (Based in Singapore)

Key accountabilities:

Managed a team of 25 staff; All product registrations, renewals, variations approvals of Finished products and Clinical Trial applications; Post marketing Surveillance; Early market access; Negotiations with health authorities; QMS, Training, Complaints handling, Ethical audits; developed Adprom SOP.

Successfully provided regulatory Strategy and worked closely with USFDA/ PMDA/TFDA/MHRA/EMEA/APAC Health Authorities etc Ophthalmics drops, devices and for BLA (Biologics License application) approvals (eg BOTOX).

Successfully launched products through expedited review programs with the USAFDA and other global health authorities such as TGA, PMDA, HAS, Health Canada through Fast track.

Worked with corporate to successfully implement eCTD and regulatory publishing for CMC, Preclinical and clinical to meet requirements of changing regulations in the markets.

Successfully conducted regulatory and quality due diligences and audits on manufacturers and suppliers

Successfully created fast track strategies to help company earn $millions

Negotiated successfully with Health authorities on product recalls and safety reports

Globally responsible for Pharmacovigilance compliance

International speaker at Scientific Conferences

1.14th Annual Pharma Regulatory Affairs Forum by Informa Connect (June 1st, 2022) in Dubai

Topic presented: The CRO’s approach to Clinical Pharma and Panel Interview on MedTech Regulatory Overview: opportunity for Pharm and Devices Industry Executives

2.Care Giving society-CAL (November 5th, 2021) in Singapore

Topic presented: Compliance in medication to manage illnesses

3.Delivering the Science of tomorrow -by DHL Clinical trials logistics (July 13th 2021) in USA

Topic presented: Delivering the science of Tomorrow. Assessing the clinical trials landscape in APAC and beyond.

4.5th AI and Machine Learning in Drug Discovery and Development Summit by Equip Global (July 6- 7th, 2022) in Singapore

Topic presented: Complying with Ethical and regulatory policies when implementing or deploying AI and Machine Learning into Drug Discovery and Drug Development

REGULATORY INDUSTRY MEMBERSHIPS

Working group member and active for 10 years with AHWPG (Asian Harmonization Working Party), ACCSQMDPWG (ASEAN Consultative Committee for Standards and Quality-Medical Device Product Working Group), PDA (Parenteral drug association) and ADVAMED

Language skills:

Advanced Fluency: English, Malay, Hindi, Bengali

Intermediate fluency: Mandarin, Japanese, Spanish, French, Italian

IT

MS Word, PowerPoint, Excel, Regulatory softwares such as RAPID, First Doc, Phoenix, LMS, PAXPRO, CORAL, SAP and Quality softwares such as QMS, iLearn, Isotrain, Trackwise and Concur.

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