Junior Consultant supporting clients in implementing security and compliance requirements through structured methods. Collaborating closely with experienced consultants in client projects.
About the role
- Senior Manager, Regulatory Affairs Operations responsible for regulatory submissions in a biotechnology firm. Overseeing documentation, compliance, and cross-functional collaboration for FDA and EMA submissions.
Responsibilities
- Lead the day-to-day regulatory operations activities across assigned programs, ensuring timely, high-quality submissions to global regulatory agencies (FDA, EMA, etc.). Responsibilities include providing advice on content and structure of submissions, attending meetings, providing templates, and formatting and publishing documents.
- Oversight of enGene’s eCTD vendor. Responsibilities include ensuring formatting, publishing, and submission of document quality for INDs, NDAs, BLAs, CTAs, MAAs, adherence to Agency regulations/guidance.
- Create Regulatory Operations process Checklists, User Guides, SOPs and Work Instructions.
- Schedule, monitor, and track Regulatory submissions to ensure corporate and health authority deadlines are met.
- Management of submissions archives and correspondence.
- Serve as subject matter expert on regional and technical submission requirements and regulatory document formatting.
- Collaborate cross-functionally with Regulatory Affairs, Clinical, Quality, and CMC to ensure submission readiness and compliance.
Requirements
- A bachelor’s degree or related experience is required.
- Minimum of 5 years in the pharmaceutical Regulatory Operations industry
- Experience managing, and publishing, eCTD submissions to health authorities with knowledge of US, EU, and Canada regional requirements.
- Experience in global drug development regulations, regulatory submissions, lifecycle management, compliance and process are required.
- Extensive knowledge of global regulatory and compliance requirements.
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