Regulatory Affairs Specialist

Position Summary

We are seeking a highly motivated and detail-oriented Assistant Manager Regulatory Affairs to support our Global Regulatory team in the development, registration, and life cycle management of biosimilar products. The role involves contributing to CMC regulatory strategy, overseeing preparation of high-quality regulatory submissions, and ensuring compliance across global markets.

Key Responsibilities Regulatory Strategy & Submissions

• Manage the preparation of highquality CMC regulatory documents, including briefing documents, CTA, IND/IMPD, MAA/BLA, and responses to regulatory authorities.

• Drive execution of regulatory plans in alignment with global filing strategies, timelines, and evolving regulatory requirements.

• Ensure regulatory submissions and updates remain aligned with biosimilar development strategy throughout the product lifecycle. Product Development & Compliance

• Provide authoritative regulatory guidance on global CMC requirements to support product development teams for analytical related aspects/process related aspects.

• Monitor, interpret, and communicate relevant regulatory intelligence and guidance affecting biosimilar products.

• Review and provide inputs on change controls and deviations shared for regulatory assessment. CrossFunctional Collaboration

• Partner with internal stakeholders across Regulatory, Quality and CMC teams to ensure alignment of regulatory strategies and project timelines Knowledge & Skills Required

• Strong understanding of global regulatory requirements, preferably in the biologics/biosimilars space.

• Hands-on experience with analytical method development, validation, method transfers, and characterization of biologic products.

• Demonstrated experience supporting CMC sections of regulatory filings.

• Ability to interpret and communicate complex scientific CMC information clearly and effectively.

• Strong foresight to anticipate potential regulatory issues and ability to recommend preventive actions.

• Excellent communication skills to clearly articulate regulatory expectations and strategy to cross-functional teams.

Qualifications

• Masters degree in Life Sciences, Biotechnology, Pharmacy, or related field

• 5–10 years of experience in Regulatory Affairs, CMC, or related areas within biologics/biosimilars.

• Strong knowledge of global biosimilar regulatory guidelines (e.g., FDA, EMA, WHO).

• Experience leading regulatory submissions from development through approval.

• Ability to manage multiple projects and deliver on timelines.

• Strong analytical and problem-solving skills.