Padmini G

About Padmini G

Regulatory Affairs | CMC Submissions | IND/NDA/ANDA | Global Markets | Compliance & StrategyI am a Global Regulatory Affairs professional with a strong background in managing submissions for cell and gene therapies, biologics, small molecules, single patient INDs and generic drug products. My expertise lies in ensuring regulatory compliance, accelerating approval timelines, and contributing to successful product development and commercialization strategies across international markets.Core Competencies:1. End-to-End Submission Management: Skilled in planning, compiling, and managing regulatory submissions across development and post-approval stages.2. Strategic Regulatory Planning: Adept at aligning regulatory strategies with evolving global requirements to mitigate risk and optimize timelines.3. Cross-Functional Collaboration: Proven ability to partner effectively with R&D, Clinical, CMC, and Commercial teams to achieve regulatory objectives.4. Global Market Expertise: Experience supporting regulatory activities in the US (FDA), EU (EMA), and Rest-of-World markets.I am passionate about improving patient access to innovative therapies and thrive in fast-paced, collaborative environments where I can lead with purpose and precision.Feel free to connect, if you’re interested in discussing opportunities to bring impactful therapies to market through strategic regulatory leadership.

Experience

1. Submission Senior Specialist, Rism

   Bristol Myers Squibb

   Dec 2023 — Present · Hyderabad, IN

   Global Regulatory submissions | Regulatory Timelines | Life Cycle Management-Manage submissions for INDs, NDAs, CTAs, annual reports, renewals, Initial submissions, post approvals, single patient INDs and variations, ensuring global regulatory compliance and timely execution of submission strategies-Skilled in PRISM-CARA, Veeva Vault, and eCTD viewers; create virtual documents, manage document control numbers, support CS portal projects, and coordinate submission closeouts with publishing vendors and in Veeva Vault-Prepare submission content plans, FDA forms, and cover letters; review dossiers for investigational and marketed applications; compile high-quality documentation aligned with GMP and QA standards-Collaborate with authors, subject matter experts, country regulatory managers, and reviewers to finalize documents; facilitate submission team and kick-off meetings; coordinate submission timelines across global teams.

Education

• Bapatla College of Pharmacy

  Master of pharmacy

  2012 — 2014

• JNTU Anantapur

  B.pharmacy

  2009 — 2012