Angela G.
Director Regulatory Strategy
- Role
- Director Global Regulatory Strategy at SUN PHARMA
- Location
- Jersey City, NJ, US
- LinkedIn followers
- 500 followers
About Angela G.
I am a Senior Regulatory Affairs Executive with over 30 years of industry experience spanning pharmaceutical development, technical operations (GMP auditor, validation specialist, CMC), Safety (Safety Lead) and Regulatory Strategy Development (Global Therapeutic Area Head/Lead). I provide leadership focused on enabling strategic planning and execution of actions meeting company and departmental goals and objectives. My key competencies include collective industry experience in Global Regulatory Strategy (development, life cycle management and established brands) working with teams to build sound regulatory strategies while interfacing with health authorities globally to get products approved. I also have Regulatory experience in the technical arena of Chemistry Manufacturing Control (CMC) which includes Regulatory Strategy development and interface with agencies in support of Module 3 of NDA as well as writing Module 3 documents. I have DMF experience as US agent for active pharmaceutical ingredients in the generic space and strategy development in Food/Dietary Supplement space. My previous experience also includes GMP Auditing, Medical Information, Pharmacovigilence and Formulation development. I\'ve had Regulatory Global product oversight in various therapeutic areas, including; Oncology, Immunology, Consumer, Cardiovascular, Metabolic and Rare Disease. I am an experienced leader of cross-functional teams, Alliance Partners, global regulatory teams as well as business development initiatives. During my tenure in industry, I received various awards for demonstrating core behaviors such as Connect and Collaborate, Decide and Act, Leadership, Performance, Customer Focus and Teamwork. I\'ve received several awards of distinction for completion of significant business/departmental impact projects.I am a licensed pharmacist with a BS and MS in Pharmacy. Volunteer Experience: I volunteer with JBWS and WISE.
Experience
Director Global Regulatory Strategy
Jul 2020 — Present · Princeton, NJ, US
Set regulatory strategy for Immune Dermatology and Neurosciences assets in Phase 2 and 3 of drug product development
Education
Long Island University
Masters in Pharmaceutics and Bachelor of Science in Pharmacy
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