Note: The job is a remote job and is open to candidates in USA. ProductLife Group is hiring a Senior Regulatory Affairs Consultant to advise clients and lead complex regulatory engagements across biotechnology and pharmaceutical programs. The role supports development programs from pre-IND and early development through registration and marketing approval.

Responsibilities

• Serve as a senior regulatory advisor and Regulatory Lead for biotechnology and pharmaceutical client engagements
• Independently develop, refine, and execute regulatory strategies aligned with client development objectives, regulatory milestones, and submission plans
• Lead complex, multidisciplinary regulatory projects and programs by defining workplans, timelines, budgets, assumptions, resource requirements, and delivery approaches
• Lead, coordinate, author, and review key regulatory documents, including:
• Health Authority meeting packages and briefing documents
• Special designation requests
• INDs, NDAs, BLAs, CTAs, and amendments
• Responses to Health Authority questions
• Regulatory correspondence
• Support, lead, or participate in formal interactions with Health Authorities on behalf of clients, including:
• Developing meeting strategies
• Preparing and coaching clients for Health Authority meetings
• Serving as Authorized Sponsor Representative when required
• Interpret and apply FDA, Health Canada, ICH, GxP, and global regulatory guidance, requirements, industry standards, and precedents
• Coordinate cross-functional client and internal teams, including Clinical, CMC, Nonclinical, Quality, Regulatory Operations, Medical Writing, and Program Management
• Oversee multiple regulatory workstreams and ensure alignment across submissions, deliverables, decisions, and timelines
• Monitor project progress and proactively identify regulatory, operational, resourcing, timeline, and client-delivery risks
• Develop practical risk-mitigation plans and communicate project status clearly to clients and internal stakeholders
• Contribute regulatory expertise to project scoping, proposals, statements of work, budget assumptions, timelines, and resource planning
• Support business development by presenting PLG s regulatory capabilities and identifying opportunities for continued or expanded client partnerships

Skills

• Bachelor s degree in life sciences, pharmacy, biology, chemistry, regulatory affairs, public health, or another relevant scientific discipline
• Minimum of 10 12 years of progressive Regulatory Affairs experience within biotechnology and pharmaceuticals, or life sciences consulting
• Demonstrated experience developing and executing regulatory strategies for development-stage programs, ideally from early development through registration or marketing approval
• Experience leading or supporting Health Authority interactions, including FDA and/or ex-U.S. agency meetings, briefing packages, responses, and regulatory correspondence
• Experience authoring, reviewing, coordinating, or leading major regulatory submissions, such as INDs, NDAs, BLAs, CTAs, amendments, special designation requests, and Health Authority meeting packages
• Strong knowledge of FDA and global regulatory guidance, ICH expectations, GxPs, and relevant industry trends
• Strong project and program management capabilities, including timeline ownership, workstream coordination, budget and resource awareness, risk identification, and mitigation planning
• Demonstrated ability to coordinate cross-functional teams and manage multiple regulatory deliverables, workstreams, timelines, and competing priorities
• Advanced degree and/or regulatory certification is preferred

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