Role Overview
In this role, you will be responsible for defining and executing regulatory strategies for small molecules, biologics, and advanced therapeutics. You will oversee submission planning, authoring, and lifecycle management for Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs).
Key Challenges & Impact
Core Challenge Solved
Harmonizing complex global regulatory submission dossiers (FDA, EMA, MHRA, Health Canada, PMDA) to avoid Information Requests (IRs) and prevent drug approval delays.
You will serve as the core regulatory strategist, steering cross-functional chemistry, manufacturing, and controls (CMC), clinical, and non-clinical teams through critical regulatory milestones.
Key Responsibilities
- Develop and execute phase-appropriate global regulatory submission strategies for biopharmaceutical assets.
- Lead the preparation, review, and eCTD compilation of Modules 1 through 5 for IND, NDA, BLA, and MAA dossiers.
- Act as primary health authority liaison, organizing briefing books and leading pre-IND, Type B/C meetings, and scientific advice procedures.
- Manage post-approval commitments, variation filings, annual reports, and regulatory labeling updates.
- Review advertising, promotional materials, and medical publications to ensure strict regulatory compliance.
- Monitor evolving FDA, EMA, and ICH regulatory guidelines, evaluating impact on ongoing development programs.
Qualifications & Requirements
- Master's degree, PharmD, or PhD in Regulatory Affairs, Pharmacy, Life Sciences, or Chemistry.
- 5+ years of progressive regulatory affairs experience within a pharmaceutical sponsor or top-tier CRO.
- Proven track record of successful eCTD filings (IND/NDA/MAA) and direct interaction with health authorities (FDA/EMA/MHRA).
- Comprehensive expertise in eCTD publishing software (Lorenz docuBridge, Veeva Regulatory, Extedo).
- Regulatory Affairs Certification (RAC) preferred.