SHIBU BABURAJ

GLOBAL REGULATORY TEAM LEAD

* ********** **, ******, ******* L1P1W4, Canada

www.linkedin.com/in/shibubaburaj

Phone: +1-647-***-**** email: adc120@r.postjobfree.com Page 1 of 5

PROFESSIONAL SUMMARY

Þ Result-driven, Regulatory affairs/ CMC/ program/ project professional with 19+ years of continuous advancement and expertise in NCE/ Small molecules, Biologics, Biosimiliars, Vaccines, Established products/ Marketed brands & Generics for Global/ Regional markets. Þ Solid knowledge base of quality and its impact on safety and efficacy during CMC, clinical & non- clinical development. Strong and skilled knowledge base on ICH, US-FDA, EU & EGM/ RoW Regulatory guidelines and Region/ Country specific regulatory requirements. Þ Accountable & responsible for the development of Global/ Regional regulatory strategies and its execution at Global/ Regional levels with support from Global/ Regional heads and local teams. Þ Accountable for setting key performance metrics ensuring alignment with Global/ Regional teams ensuring compliance meeting KPIs and organizational & functional objectives. Þ Lead CMC/ Clinical development program/ project for NCE/ Small molecules, Biologics, Biosimiliars, Vaccines, Established product/ Marketed brand products & Generics for Global/ Regional markets. Represent Regulatory function in product development, project/ program management & portfolio/ launch management.

Þ Strong Regulatory affairs/ Regulatory CMC expertise in Pre-approval submissions (IND, IMPD, CTA, CTN, BB, IB, PIP, Amendments, NDA, MAA, BLA, Generics & Biosimiliars), Post-approval submissions & Life cycle management submissions (HA responses, Renewals, Variations, Annual reports, change management & Line extensions) Þ Lead Health Authority meetings/ interactions/ negotiations at appropriate stages of clinical development project/ program preparing appropriate document packages (IB, BB, SA, PIP etc.) prior to the meetings.

Þ Superlative liaising, communication & negotiation skills with internal functions, Health Authorities, Affiliates & Corporate delivering successful Regulatory/ Clinical/ Commercial/ Launch strategies. Þ Forge transversal relationships with professional associations, industries and health authorities for regulatory lobbying and influence policy/decision making. Þ Proven skills working in matrix teams & in developing and leading Global/ Regional Regulatory Program/ Project including budget accountability, allocations, reporting, execution and completion as per the agreed Global Program timelines.

Þ Experienced in building high performing teams, systems and business processes. Skilled coalition-builder with multicultural experience building high performing teams. Þ Experienced in management of external/ third party relationships, in-licensing activities, new product assessments, due diligence, Site/ CRO/ CMO audits, product life cycle management, branding/ artworks & Pharmacovigilance activities. Þ Exemplary leadership skills, line management, people development & training, management of local RA heads & local teams, which effectively motivates & achieve functional and organizational objectives.

Þ Expert lean coordinator/ lean trainer & Lead Regulatory Intelligence in the evaluation of impact of changes in Global/ Regional Regulatory guidelines on RA strategies & business and related resolutions.

KEY SKILLS

• Regulatory CMC Strategy

• Technical CMC writing/ reviewing

• Due diligence/ Inspections

• Small molecules, Biologics, Vaccines,

SHIBU BABURAJ

GLOBAL REGULATORY TEAM LEAD

3 Brownridge Pl, Whitby, Ontario L1P1W4, Canada

www.linkedin.com/in/shibubaburaj

Phone: +1-647-***-**** email: adc120@r.postjobfree.com Page 2 of 5

• Regulatory Affairs Strategy

• Regulatory Program Management

• Global Regulatory Guidance

• Non-clinical and Clinical Development

• Pharmaceutical Product Development

• Drug Quality, Safety & Efficacy

• Project Lead in Multi-disciplinary

environment

• Third Party/ CRO/ CMO Management

Biosimilars and Generics

• Global Market Expertise

• Health Authority interactions

• Team Leadership (mentoring, coaching,

leading & development)

• Problem solving, analytical thinking and

negotiation skills

• Adaptive communication

GLOBAL MARKET EXPERTISE

EU, US, JAPAC, AU/ NZ, MENA, Canada, China, South Africa, EGM/ RoW markets. DRUG PRODUCT EXPERTISE

• NCE/ Small molecules (PoC to Original submission & Life cycle management).

• Biologics (PoC to Original submission & Life cycle management) - mabs, polypeptides, interleukins, hormones, oncolytic virus, lentivirus, CAR-T etc.)

• Vaccines (PoC to Original submission & Life cycle management)

• Biosimiliars/ Biosimilars

• Established products/ Marketed brand products & Line extensions.

• Generic products.

DOSAGE FORM EXPERTISE

• Solid orals, Pellets, Liquids & Semi-solids.

• Ophthalmic, Parentrals/ Injectables & Lyophilisates.

• Pre-filled syringes and combination products.

THERAPEUTIC AREA EXPERTISE

Oncology, CNS, CVS, Anti-infectives, Pain/ Inflammation, Hematology, Gastro-intestinal, Dermatology, Ophthalmic, Respiratory/ inhalational products & Autoimmune disorders. PROFESSIONAL EXPERIENCE

Sanofi Pasteur

North York, Canada

Jan-2018 – Present

Global Regulatory Team Lead

Role: Project Lead; Team Size: 20-25 Per Project; Direct Reports: 2

• Develop and implement the regulatory strategy for registration of new vaccines or license update worldwide and co-ordinate between clinical development, product development, marketing and CMC related functions and perform change control assessments.

• Co-ordinate the regulatory submissions to regulatory authorities worldwide for clinical trial application (CTA), investigational new drug application (IND), marketing application (MAA/ NDA/ BLA), related amendments or variations and all routine license maintenance activities.

SHIBU BABURAJ

GLOBAL REGULATORY TEAM LEAD

3 Brownridge Pl, Whitby, Ontario L1P1W4, Canada

www.linkedin.com/in/shibubaburaj

Phone: +1-647-***-**** email: adc120@r.postjobfree.com Page 3 of 5

• Monitor, track and communicate on the vaccine development and worldwide registration projects/ programs under personal responsibility and aid in the preparation of briefing documents, position papers and proposals on potential issues.

• Function as regulatory lead for the assigned products/ projects within all strategic forums and as regulatory liaison with all third parties and worldwide regulatory authorities. Co-ordinate with regulatory operations for planning and prioritization.

• Develop, review and approve SOPs on various business processes for effective co-ordination and functioning.

• Manage communication with worldwide regulatory agencies and third parties holding negotiations and discussions towards product/ project strategies, issues and communicate appropriately and aid in the preparations of pre-reads/ presentations.

Sanofi-Aventis

Singapore

Jan-2013 – Dec-2017

Head, Regulatory affairs/CMC

Role: Team Lead; Direct Reports: 20

• Regulatory affairs strategy for Vaccines, NCE/ Small molecules, Biologics, Biosimiliars, Established product/ Marketed brand products

& Generics products for Global markets & Regional markets.

• Liaising activities with internal functions, HAs, Affiliates and Corporate for sound and successful regulatory affairs/CMC strategy. Liaising with Health Authorities on key issues/ projects & Regulatory lobbying for policy/ decision-making.

• Global Regulatory program/project management for pre-approval/ post-approval/ generics products and related customizations. Responsible for development and execution of Global/ Regional regulatory strategies.

• Medical/Clinical strategy for products requiring clinical trials/ bioequivalence studies.

• Budgeting, allocation and reporting with respect to project management, execution and completion.

• Line management, people development and training.

• Portfolio development, management and managing external sourcing and in-licensing related activities. Audits (API sites/ DP sites/ CROs/ CMOs) and related gap analysis/ due diligence.

• Branding strategy (Artwork/ Trademark/ Pack harmonization and related legal affairs).

• Regulatory lead in launch and commercialization strategies and Pharmacovigilance activities.

• Regulatory intelligence lead for Global & Region. Pfizer

Singapore

Apr-2011 – Dec-2012

Regulatory Affairs/CMC Strategist

Role: Team Lead; Direct Reports: 8

• CMC development and Regulatory submission strategies for NCE/ Small molecules, Biologics, Biosimiliars & Established product/ Marketed brand products for Global markets & Regional markets.

• Manage lifecycle submissions including Amendments, Variations, SHIBU BABURAJ

GLOBAL REGULATORY TEAM LEAD

3 Brownridge Pl, Whitby, Ontario L1P1W4, Canada

www.linkedin.com/in/shibubaburaj

Phone: +1-647-***-**** email: adc120@r.postjobfree.com Page 4 of 5

Gap analysis, Renewals, Annual reports, Supplemental submissions, HA responses, CTD updates and Line extensions.

• Medical/Clinical strategy for non-clinical & clinical development and provide regulatory support for clinical trials/ bioequivalence studies.

• Management of external sourcing, third party relations and in- licensing activities.

• Manage Regulatory submission publishing for electronic submissions and eCTD compliance.

• Stakeholder management (internal and external including Country offices and Health Authorities).

• Maintenance of electronic systems for Regulatory Compliance.

• Function as Regulatory Intelligence.

Novartis

Hyderabad, India

May-2006 – Mar-2011

Regulatory CMC Manager

Role: Individual Contributor + Team Lead; Direct Reports: 6

• CMC development and Regulatory submission strategies for NCE/ Small molecules, Biologics, Biosimiliars, Established product/ Marketed brand products for Global markets (US, EU, JP and EGM/RoW).

• Manage lifecycle submissions including Amendments, Variations, Gap analysis, Renewals, Annual reports, Supplemental submissions, HA responses (during development, product registration and product lifecycle), Site transfers, CTD updates and Line extensions.

• CMC project management via matrix team involving non-clinical development, clinical development, CMC submissions and post- approval maintenance.

• Medical/Clinical strategy for non-clinical & clinical development and provide regulatory support for clinical trials/ bioequivalence studies.

• Co-ordination, preparation and submission of EU renewals for MRP, National and Central renewals and Annual Reports for the active US INDs/NDAs/DMFs/BLAs.

• Formulate training plan and coach new joiners, peers and colleagues. Expert lean coordination, lean trainings and CMC team resource allocations.

• Conceptualization, preparation, review and approval of SOPs and DOGs.

Ranbaxy

(Sun

Pharmaceuticals )

Gurgaon, India

Research Scientist (DRA)

Role: Individual Contributor + Team Lead; Direct Reports: 2

• CMC submission strategies/ CMC authoring in CTD (Module 2 and 3)/NTA (Part I and II) formats for registration of Generic MAAs in the EU (European Union).

• Strategize and implement regulatory submissions in European Union via National, MRP and DCP procedures.

• Co-ordination and preparation of HA responses, Variations (Type 1 & II), EU Renewals and Line extensions. Regulatory CMC change management.

SHIBU BABURAJ

GLOBAL REGULATORY TEAM LEAD

3 Brownridge Pl, Whitby, Ontario L1P1W4, Canada

www.linkedin.com/in/shibubaburaj

Phone: +1-647-***-**** email: adc120@r.postjobfree.com Page 5 of 5

• Liaise and co-ordinate with Country Offices in European Union.

• Regulatory project management, stakeholder management meeting project timelines & identify and resolving project issues.

• Training and coaching of new joiners and mentoring support to peers and colleagues.

Dabur

(Fresenius Kabi)

Ghaziabad, India

Jul-2002 – Jun-2003

Research Trainee (PDR)

Role: Individual Contributor; Direct Reports: 0

• Drug product development, scale-up and tech-transfer for various dosage forms including Suspensions, Tablets, Hard capsules, Micro- emulsion gels, Dispersible tablets and Pellets.

• Development and optimization of yield of fermented products.

• Process development and optimization of unit operations including Dissolution enhancement, Film-coating and Extrusion-spheronization technology.

• Stability protocol design and conduct of stability studies for various dosage forms.

Hamdard University

(Faculty of

Pharmacy)

New Delhi, India

Jul-2001 – Jun-2002

Research Scholar (M.Pharm II)

Role: Individual Contributor; Direct Reports: 0

• Completed research project entitled “Formulation development and evaluation of novel muco-adhesive buccal films for the delivery of Insulin” towards the award of Masters in Pharmacy (Pharmaceutics) degree by research.

EDUCATION

Hamdard University

(Faculty of Pharmacy)

New Delhi, India

Jul-2000 – Jun-2002

• Masters in Pharmacy – By Research (Pharmaceutics, Pharmaceutical Technology, Industrial Pharmacy,

Pharmaceutical Management, Drug design)

Hamdard University

(Faculty of Pharmacy)

New Delhi, India

Jul-1996 – Jun-2000

• Bachelor of Pharmacy (Pharmaceutical Sciences)

PERSONAL DETAILS

Date of birth • 27-May-1978

Languages known • English (Fluent)

• German (Basic)

REFERENCES

• References will be provided upon request.

Contact this candidate