Job Summary : - Lead regulatory strategy and execution for biosimilar BLAs/MAAs with primary ownership of Module 3 (CMC) and Module 5 (clinical). Partner cross-functionally (Process/Analytical Development, Quality, Clinical, PV, Supply Chain) to ensure high-quality dossiers, timely health-authority interactions, and successful approvals and lifecycle management.

Key Responsibilities

 Regulatory strategy (biosimilars)

- Develop and drive US 351(k) and ex-US (EMA/MHRA/HC/TGA/CDSCO, etc.) strategies, including stepwise evidence plans (analytical similarity → PK/PD → confirmatory clinical).
- Plan agency meetings (BPD/Type B/C, Scientific Advice), briefing packages, and follow-ups.

 BLA/MAA authoring – Module 3 (CMC)
- Own authoring, review, and integration of 3.2.S/3.2.P (drug substance/product), control strategy, validation/PPQ, stability, comparability, specifications, container-closure, facility/equipment, and batch records.
- Ensure alignment to ICH Q5/Q6/Q8–Q12, USP/Ph.Eur., and regional biosimilar expectations.
- Coordinate CMC responses to IRs/deficiency letters and post-approval changes (PAS/CBE/AR).

 BLA/MAA authoring – Module 5 (Clinical)
- Lead or coordinate compilation of clinical overview/summary, study reports (PK/PD, efficacy, safety, immunogenicity), RMP/REMS inputs, and literature.
- Ensure consistency with Modules 2.5/2.7 and statistical/clinical narratives.

 Submission operations




- Drive high-quality eCTD submissions and life-cycle events; oversee publishing/validation.
- Maintain submission trackers, commitments, and HA correspondence archives.

 Health-authority engagement
- Draft talking points, manage Q&A;, and lead cross-functional preparation for meetings/inspections.

 Change control & lifecycle
- Assess regulatory impact for CMC changes (process, site, specs), author variations/supplements, and negotiate filing categories and timelines globally.

 Cross-functional leadership
- Embed RA in development plans (QbD, process characterization, analytical method validation).
- Train teams on biosimilar regulatory expectations and dossier standards.

 People & vendor management (Senior Manager)
- Mentor junior RA staff; manage consultants, CROs, and publishing vendors.

Desirable Qualification and Skills

Education: Degree/Master degree in Biotechnology, Biochemistry, or related field

Experience 9–12+ years with biosimilar or biologics approvals/MAA/BLA filings; demonstrated lead authorship for Module 3 and coordination of Module 5; prior HA meeting experience.

Desirable Skills

 Robust knowledge of US 351(k) and EU biosimilar guidelines, ICH Q/E, GMP/GCP, and eCTD standards.

 Proven ability to translate technical CMC/clinical data into clear regulatory narratives.

 Excellent written/oral communication; stakeholder management across time zones.

📌 Manager/Senior Manager - Regulatory Affairs (Mumbai)
🏢 BioSimilar Sciences India
📍 Mumbai