Sr. Specialist - Regulatory Affairs - Operations 4C

About this role

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Skills you'll use

What you'll do

• Responsible for leading and executing CMC regulatory strategies for assigned post‑approval pharmaceutical products in alignment with global regulations, guidance and defined regulatory strategies, including preparation and critical review of data and documents required for post‑approval CMC submissions and lifecycle management.
• Accountable for authoring, reviewing, and coordinating CMC documentation to support worldwide post‑approval changes and lifecycle activities (variations, supplements, amendments) and responses to health authority questions for commercial products per established business processes and systems.
• Provide regulatory leadership as needed to product in-license/due diligence review, product divestment and product withdrawal.
• Collaborate effectively with cross‑functional teams (e.g., QA, QC, manufacturing, supply chain, packaging, device, and analytics), CMOs, and external partners to track and close out documentation gaps, compliant execution of change management, and conduct all activities with an unwavering focus on regulatory conformance.
• Ensure timely approvals for the submissions and Product supply continuity.
• Deliver all regulatory milestones for assigned products across the product lifecycle.
• Strong experience in CMC requirements for small molecule/biologic products.
• Proven experience in critically reviewing detailed scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
• Demonstrates strong written and verbal communication skills, including the ability to translate complex technical concepts into clear regulatory justifications and to influence decision‑making in cross‑functional and global forums.
• Shows sound understanding of related technical disciplines (such as pharmaceutical manufacturing, analytical testing, quality assurance, and quality systems) and applies this knowledge when defining regulatory strategies and compiling CMC dossiers.

Who can apply

• Bachelors - Health Administration, Bachelors - Healthcare, Bachelors - Pharmacy, Masters - Public Health, Masters - Regulatory Affairs
• Certified Compliance Officer (CCO) - VskillsVskills, Certified Public Accountant (CPA) - Perfekt SzolnokPerfekt Szolnok, Certified Regulatory Compliance Manager (CRCM) - The International Association of Risk and Compliance Professionals (IARCP)The International Association of Risk and Compliance Professionals (IARCP)
• Pharmaceutical Regulatory Affairs
• English (Required)
• Language Proficiency -
• Additional Job Location -

Perks & benefits

About Genpact

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