Pharmaceutical Regulatory Affairs Resume Sample

Priya Mehta, PhD.

VICE PRESIDENT | HEAD OF REGULATORY AFFAIRS | PHARMACEUTICAL SECTOR

Toronto, ON | [email protected] | (555) 456-7821

Results-oriented VP of Regulatory Affairs with a 15+ year track record of enabling clinical, CMC, and non-clinical development, with experience in both early- and late-stage product development. Dedicated to building high-performing teams, driving continuous improvement, and ensuring strict compliance with regulatory requirements.

• Regulatory Strategy: Talented strategist with a history of creating effective regulatory plans, using a blend of technical and scientific knowledge, business acumen, and insight into the ever-changing regulatory landscape.
• Liaison: Exceptional communicator and relationship builder with the capacity to act as a trusted liaison when dealing with regulatory agencies such as the FDA and EMA.
• Technical Guidance: Influential subject matter expert and invaluable resource to internal teams and the senior executive committee with a history of guiding products from ideation to Proof of Concept.
• Due Diligence: Able to conduct intensive due diligence on range of potential development opportunities.
• Project Leadership: Skilled project leader with an aptitude for optimizing team performance during all phases of the project lifecycle from scoping and strategic analysis to execution, testing, and stakeholder engagement.
• Problem Solving: Natural problem solver with history of overcoming obstacles by designing innovative solutions.

Areas of Expertise

Professional Experience

NovaThera Biologics | Toronto, ON                                                                    11/2022 – Present

VP Head of Regulatory Affairs & Medical Writing

Currently orchestrating all aspects of the Regulatory Affairs function to facilitate nonclinical, clinical, and CMC development of novel antibody-fusion and bispecific antibody products for treatment of ulcerative colitis and severe acute alcoholic hepatitis. Achievements to date include the following:

• Maintain comprehensive knowledge of legal directives and compliance requirements to provide ongoing guidance for senior executive peers and divisional leaders in an evolving regulatory landscape.
• Foster consultative relationships with colleagues and strategic partners to enable a variety of programs.
• Project-manage the development of ophthalmology products in collaboration with Boehringer Ingelheim.

GeneCore Therapeutics | Montreal, QC                                                          03/2022 – 11/2022

Head of Regulatory Strategy & Science

Provided regulatory leadership for complex clinical and CMC development operations focusing on autologous gene-edited hematopoietic stem cell therapeutics for sickle cell and other diseases. Highlights included the following:

• Negotiated a decentralized late-stage manufacturing process for sickle cell gene edited product with FDA.
• Leveraged technical awareness, regulatory knowledge, and business considerations to provide strategic insights and optimize development activities in collaboration with multi-disciplinary teams and external stakeholders.
• Designed a robust regulatory strategy for gene-edited cellular therapies to align with global requirements.
• Utilized outstanding interpersonal communication skills to act as a focal point for FDA interaction and led key submissions that enabled a decentralized late-stage manufacturing process.
• Conducted regulatory assessment and due diligence for various business development opportunities.
• Formed mutually beneficial strategic partnerships to drive programs forward and achieve ambitious objectives.
• Worked in tandem with the Quality team to introduce GxP compliance to ensure that products are produced in line with best practice manufacturing, control, storage, and distribution processes.

BioNova Sciences | Vancouver, BC                                                           04/2021 – 02/2022

Executive Director – Regulatory Affairs – Ophthalmology

Managed the Regulatory Affairs function for this global Biosciences organization including in-depth strategic planning, analysis, and interaction with regulatory agencies (FDA). Achievements included:

• Oversaw filing of BLA and chaired the BPD Type 2 meeting with the FDA to provide a detailed analysis of the development plan for the proposed Eylea® biosimilar.
• Acted as regulatory lead to manage operational planning and filing of BLA for a proposed biosimilar to Lucentis® in collaboration with a strategic partner (bioeq).
• Carried out due diligence activities for external assets and defined regulatory strategy for development of immune oncology therapeutic products.

MedNova Therapeutics | Ottawa, ON                                                          06/2015 – 04/2021

Senior Director – Regulatory Affairs, 02/2021 – 04/2021
Director – Regulatory Affairs, 07/2019 – 01/2020
Associate Director – Regulatory Affairs, 08/2016 – 06/2019
Senior Manager – Regulatory Affairs, 06/2015 – 07/2016

Spearheaded the Regulatory Affairs department with accountability for designing and implementing infrastructure and processes to maximize the likelihood of CMC, clinical and nonclinical development regulatory success of different development programs. Hired, trained, and mentored the regulatory and medical writing functional team. Provided expert guidance for senior executives and acted as a critical resource for colleagues on all matters involving regulatory affairs. Progressed to roles of increasing managerial responsibility due to outstanding contributions. Highlights:

• Used strong interpersonal communication skills to liaise directly with review divisions at the FDA including Pre-IND, Type C, and Scientific Advice Meetings across four programs.
• Optimized team performance and capability in supporting the clinical and CMC strategic development of new investigational biologics in the ophthalmology, liver disease (nonalcoholic steatohepatitis, primary biliary cholangitis, primary sclerosing cholangitis), diabetes, and immune oncology therapeutic space.
• Created a range of procedures to facilitate document preparation and submission activities and developed processes for the medical writing group to improve report writing, protocol writing, and CSRs.
• Played a leading role in the strategic planning cycle as a member of the Development Review Committee.
• Provided leadership for a cross-functional team that achieved the approval of five initial regulatory applications in US and Australia and several clinical trial applications with limited resources in different therapeutic areas.
• Successfully filed orphan applications (2 in EU, 1 in US) and a breakthrough designation request application.
• Advised technical and non-technical colleagues on the content of documents, including drafting, review, and preparation of INDs, IMPDs, CTAs, briefing documents, and other regulatory filings for regulatory agencies.
• Developed and introduced GxP processes in collaboration with Quality consultants.
• Prepared the company for inspections/audit readiness by leading the completion of company SOPs.
• Developed in vitro diagnostic strategy for a selection of patients in the oncology therapeutic space.
• Devised a strategic plan to validate tools that support the use of patient reported outcomes as a co- primary endpoint for treatment of cachexia.

GlobalPharma Inc. | Mississauga, ON                                                     09/2013 – 06/2015

Manager – Regulatory Affairs, HIV

Delivered regulatory guidance for clinical operations teams during all phases of studies. Accomplishments included:

• Acted as regulatory lead and FDA liaison supporting NDA first cycle review and resubmission for Vitekta®.
• Filed an IND for novel HIV integrase inhibitor (small molecule).
• Led a Recommendation for Temporary Use (RTU) submission to ANSM for Truvada for PrEP®.

SynGenix Pharmaceuticals | Calgary, AB                                                    01/2009 – 08/2013

Senior Regulatory Associate

Enabled late state development activities as regulatory lead and FDA liaison for three investigational drug products (monoclonal antibodies). Highlights included the following:

• Directed a portfolio of concurrent projects for candidates at various stages of development from pre- IND to Phase 3 in the metabolic, endocrine, cancer, and ophthalmic therapeutic space.
• Obtained approval of three INDs submitted to the FDA (Division of Metabolism and Endocrinology Products) and several CTAs to Regulatory Agencies.
• Managed the Module 1 and Module 2 clinical sections of Biologic License Application for Eylea®.
• Attended and presented at FDA meetings (Type C and End of Phase 2) and other Agency Meetings (CHMP, PMDA and Health Canada).
• Worked in conjunction with SMEs and Sanofi team members to remove partial and complete holds on INDs.
• Owned all documentation including annual reports, periodic safety reports, development safety update reports, and investigator brochures.

Early Career Roles

Scientist, SynGenix Pharmaceuticals
Postdoctoral Fellow, Biomedical Research Institute of Canada
Postdoctoral Research Associate, University of British Columbia

Education

PhD in Medicinal Chemistry and Pharmaceutics
University of Alberta – Faculty of Pharmacy & Pharmaceutical Sciences
Awarded John Bruce Scholarship for Outstanding Graduate Student in Pharmaceutical Sciences

Bachelor of Pharmaceutical Science
National Institute of Chemical Technology, India

Publications

• Doe, P. 11 October 2016. Global Regulatory Strategy. Regulatory Focus Magazine (online).
• Lu, Y, Lian, H, Sharma, P. Schrieber-Agus, N, Russell, RG, Chin, L., Van der Horst, GT, Bregman, DB. 2001. Disruption of the Cockayne syndrome B gene impairs spontaneous tumorigenesis in cancer- predisposed Ink4a/ARF knockout mice. Mol Cell Biol. 21(5):1810-1818.
• Sharma, P. and Schriber-Agus, N. 1999. Mouse models of prostate cancer. Oncogene 19, 5349-5355.
• Duan, D., Sharma P., Dudus, L, Zhang, Y., Sanlioglu, S., Yan, Z., Yue, Y., Lester, R., Yang, J., Fisher,

K.J. and Englehardt, J.F. 1999. Formation of adeno-associated virus circular genomes is differently regulated by adenovirus E4 ORF6 and E2a gene. J. Virology. 73(1) 161-169.

• Sharma, P., Dudus, L., Nielsen, P.A., Clausen, H., Yankaskas JR, Hollingsworth MA and Engelhardt, J.F., 1998. MUC5B and MUC7 are differentially expressed in mucous and serous cells of submucosal glands in human bronchial airways. Am. J. Resp. Cell and Mol. Biol. 19(1) 8568- 8577 (journal cover article).
• Duan, D., Sharma, P., Yang J, Yue Y., Dudus L., Zhang, Y., Fisher, K.J. and Engelhardt, J.F. 1998. Circular Intermediates of Recombinant Adeno-associated virus have defined structural characteristics responsible for long-term episomal persistence in muscle tissue. J. Virology. 72 (11) 8568-8577.
• Sharma, P M., Sarkar, M.G., Virmani, A.K., Gazdar, A.F. and Sachdev, G.P. 1999. Evidence of Mucin Secretion in Human Lung Adenocarcinoma Cell Lines NCIH650 and NCIH2077 and Effect of Select Secretagogues on Mucin Secretion. Bioscience Reports, 19(5):473-48.

Patents

• US 7,666,532 (issued February 23, 2009) entitled “Monomeric Self-associating Fusion Polypeptides and Therapeutics Uses Therof”
• US 7,608,440 (issued October 27, 2008) entitled “Interferon-gamma Antagonists and Therapeutic Uses Thereof”
• US 7,557,284 (issued July 7, 2008) entitled “IL-18 Specific Polypeptides and Therapeutic Uses Thereof”