GM - Regulatory (Discovery) novel biologics, Bangalore
- Leading Indian
- 15 - 18 years
- Bengaluru
- 2 months ago
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Job Description
QUALIFICATIONS
- Education: Advanced degree in Life Sciences, Pharmacy, or related field
- Experience:
- 15+ years in regulatory affairs, including 5+ years leading global teams in biopharmaceuticals.
- Proven track record in NDAs/BLAs for novel therapies (ophthalmology/metabolic disorders preferred).
- Expertise in FDA/EMA interactions, including Pre-NDA meetings and Advisory Committees.
- Skills:
- Proficiency in clinical trial design, statistical analysis, and regulatory writing.
- Familiarity with eQMS tools (Veeva, TrackWise) and regulatory intelligence platforms.
Global Regulatory Strategy & Submissions
- Develop and execute regulatory strategies for novel biologics, including pre-IND meetings, orphan drug designations, and accelerated approvals.
- Lead NDA/MAA submissions for US FDA, EMA, and other agencies, ensuring compliance with ICH guidelines and regional requirements.
- Oversee clinical trial applications (CTAs/INDs) and provide input on study design, endpoints, and risk mitigation.
Team Leadership & Cross-Functional Collaboration
- Manage a global team of regulatory professionals, fostering expertise in biologics, ophthalmology, and metabolic disorders.
- Partner with R&D, Clinical Development, and CMC teams to align regulatory plans with development milestones.
Compliance & Audit Management
- Ensure adherence to GCP, GMP, and 21 CFR Part 11 standards during regulatory inspections and audits.
- Maintain submission timelines using eCTD formats and electronic submission gateways
Team & Project Management
- Mentor QA leaders across sites, fostering a culture of quality and accountability.
- Design training programs on GMP/GLP updates, inspection readiness, and root cause analysis methodologies.
Post-Marketing & Lifecycle Management
- Direct post-approval regulatory activities, including variations, renewals, and safety updates.
- Monitor evolving regulations (e.g., FDAs Novel Drug Approvals guidance) and implement proactive compliance measures.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Legal & RegulatoryRole Category: Legal & Regulatory - OtherRole: Legal & Regulatory - OtherEmployement Type: Full timeContact Details:
Company: Leading IndianLocation(s): Bengaluru+ View Contact
Keyskills: Biosimilars Regulatory Affairs novel biologics Injectables regulatory intelligence platforms biopharmaceuticals ophthalmology Veeva TrackWise metabolic eQMS tools
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₹ 40-45 Lacs P.A
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