Priya Maran

Glen Allen, VA

804-***-****

ad0vkq@r.postjobfree.com

Profile

Expertise in managing multiple Management across all regulatory systems. Proven track record in meeting project milestones, managing timelines while keeping quality standards as a priority for the success of the organization and ensuring compliance with industry standards. I have overall 12+ years of experience in various Pharmaceutical Departments.

ISO

Good Manufacturing Practice (GMP)

ICH Guidelines

U.S. Food and Drug Administration (FDA)

Electronic Submissions Gateway (ESG)

Center for Drug Evaluation and Research (CDER)

Center for Biologics Evaluation and Research (CBER)

European Medicines Agency – EMA

Common European Submission Portal (CESP)

Medicines and Healthcare products Regulatory Agency (MHRA)

Regulatory Compliance

Regulatory Documentation

Regulatory Requirements

XEVMPD/Art. 57 submissions

Corrective and Preventive Action (CAPA)

Education

B Pharmacy, Vinayaka Mission College of Pharmacy, Salem (2008)

PG Diploma in Regulatory Affairs, Global Institute of Regulatory Affairs AFFLILIATED TO: National Institute of Pharmaceutical Education and Research, Pune (2016) Skills

Excellent working knowledge and advanced experience with FDA, EMA, MHRA/ICH guidance for INDs, NDAs, ANDAs, BLAs, EU (CP, National, MRP/DCP & CP), ROW and major supplements/amendments.

Collaborative knowledge of eCTD Submission, build and publishing, IND, NDA, IND-NDA annual reports, NDA/ BLA cover sheet, eCTD filing and authoring submissions.

Experience in Regulatory Publishing using eCTD Express, Pearl, GDMS (Documentum), Liquid insight, SAP Production, Rosetta Phoenix, MS Office, CDER, CBER, Lorenz Validator and Viewpoint.

Working with CTD dossier Module 1 through Module 5 (Writing and Review)

Performing CMC compliance activities, including CMC content writing and review/Literature survey

Knowledge of internal and external Submission & publishing standards for US and EU

Thorough knowledge of 21 CFR part 11, FDA, GMP, GCP and GLP standards.

Planning and coordination post approval submissions

Operate as Subject Matter Expert in dossier types and/or processes with responsibility for training and mentoring fellow colleagues.

Technical and Strategic Leader with Critical and Problem-Solving skills. Employment History

Regulatory Affairs –

Team Lead at Navitas Life Sciences Private limited (Client-Pfizer), Chennai AUG 2017 — MAY 2023

Understanding of regulatory requirements & knowledge areas for several markets – US/EU regions.

Working with CTD dossier Module 1 through Module 5 (Writing and Review)

Handling submission/Publishing through system-based tools

Lead the preparation, submission, and management of ANDAs.

Liaise with the FDA and other relevant regulatory bodies to ensure submissions are compliant and meet all required standards.

Planning and coordination post approval submissions (CBE-30, PAS, CBE0, PADER, Annual Report, FDARA, Withdrawal submissions) to agency based on the review of Post approval submission.

Dispatching the submission packages directly to USFDA by ESG and for EU through CESP/EMA/UKMHRA gate way web portal.

Provide regulatory CMC support for all phases of the product development in the assigned portfolio and interface with Pharmaceutical Development, Project Management, Operations, Supply Chain, Quality, and Regulatory colleagues. Provide expert recommendations and decisions on regulatory issues relating to CMC, including proactive risk management and mitigation.

Develop effective regulatory CMC strategies for global submissions knowing the life cycle of drug product from development through commercialization and interpret and apply local regulations and guidance's to the life cycle of a drug product.

Oversee CMC documentation packages for regulatory submissions. Includes initial submission to Health Authorities, and preparation of responses to questions from Health Authorities.

Performing GAP Analysis

Drive submission coordination activities such as Responsible for the coordination, preparation, and submission of various electronic, NeeS and eSUB formats of submissions.

Handled National, MRP, DCP and CP Submission for EU region, PSUR submissions & Swiss submissions.

Type of variations compiled: Initial, Variations, (Type IA / IB and II), Line Extensions, Responses (Answer to Questions), Validation Responses and PIP). Grouping, Work sharing & Super-grouping.

Post approval submission around 300 to 400 submissions submitted per year.

Ensure that submissions are of high quality, meet all regulatory requirements and comply with corporate goals and directives within the timeline.

Collaborating with product teams and/or third-party partners, the incumbent will be responsible for project management of activities, in support of regional and national regulatory submissions component build and delivery within the specific due time.

Operate as Subject Matter Expert in dossier types and/or processes with responsibility for training and mentoring fellow colleagues.

Reviewing of various technical documents including the Product development reports, Specifications (API, FP and RM), Stability protocols, Stability data, QC analysis reports and batch manufacturing records etc. for various pharmaceutical formulations.

Execute plans and complete tasks according to business goals. Responsible for compiling the submissions to the regulatory agencies.

Done document level and submission level QC for Dossiers.

I am very flexible to work with the below TOOLS, o PEARL

o GDMS

o Liquent insight

o Lorenz Validation

o SAP Production

o ROSETTA Phoenix

o eCTD Express

o Viewpoint

Ensure that capacity & team capabilities are aligned to pipeline i.e., utilization.

Enhance customer experience by hitting all SoW commitments with respect to project timings without compromising quality.

Train key staff in other propositions so that they can identify opportunities during ongoing projects.

Implement communication plans and stakeholder management plans as part of our project management methodology.

Update websites periodically with the regulatory services offerings. Provide ideas & content for webinars, thought leadership.

No project starts due to lack of capacity or capabilities.

I have Managed 22 members in my team.

XEVMPD/Art. 57:

Enhanced my support for XEVMPD/Art. 57 submissions submitted through EudraVigilance by EMA Gateway.

Performing XEVMPD entries like Initial, Update, Invalidation & Nullification.

Maintaining the product wise tracker of the entries done from initial stage of the product to the current approved information of the product.

Agency Support:

US: Communicating agency on behalf of applicant to submit controlled correspondence, Meeting requests, Preassigned application numbers via CDER NextGen portal.

EU: Coordinating with EU regulatory agency and clarifying query related dispatched submissions.

Regulatory Affairs / Research &Development-Executive at TTK HEALTHCARE LTD, Chennai MAY 2013 — JULY 2017

Prepared Dossier as per different country requirements and work precisely according to procedures, rules and regulations with timely manner for various international markets

(created checklist)

Prepared dossier as per CTD format (Module 1 through Modul 5 Writing, Review & Submit to Agency)

Provided regulatory support for the implementation of ROW Market to expand the global footprint of the company.

Tracking of dossiers submission till the Launch.

Arranging registration samples for regulatory submission as applicable.

Prepared dossier for various dosage forms such as tablet, Capsules, Cream, Syrup, Suspension, and feed supplements

. Reviewing and proof reading of artwork and regulatory documentation.

Assisting in preparation and review of SOP's and other departmental documents.

To prepare responses and compile regulatory authority queries.

Reading and understanding the latest Regulatory guidelines of the target countries.

Involved in co-ordination with QA-QC Departments for preparation and receiving of Documents.

Documentation for drug licensing activities and Food Licensing activities

Documentation for Local Body (Corporation and Municipality Departments).

CMC content writing and review/Literature survey.

Development of Pharmaceutical dosage form.

Performing laboratory trials.

Prepared costing data sheet.

Analytical Services Department-Executive at Strides Arcolab Limited, Bangalore JULY 2009 — AUGUST 2010

Responsible for GLP compliance.

Responsible for monitoring the instruments calibration.

Trouble shooting of lab instruments.

Handling of HPLC (Agilent 1100 & 1200 Series, Jasco, Waters)

Handling of Dissolution Apparatus (Varian, Electro lab, Distek)

Various analyses related to Bulk Drugs from raw materials to finished goods.

Analysis of raw materials finished products and in process analysis.

Determination of all active ingredients using HPLC, UV – VIS Spectrophotometer and FTIR.

Calibration of Instruments.

Maintaining records of analysis and chemicals.

Documentation support to Regulatory Affairs Department. Quality Control -Trainee chemist at MICAL (The Chennai industrial co- operative analytical laboratory), Chennai

APRIL 2009 — JUNE 2009

Analysis of raw materials finished products and in process analysis.

Maintaining records of analysis and chemicals.

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