Senior Regulatory Affairs Consultant

PLG; United States; Presencial; USD 120.000 - 210.000; Jornada completa

Descripción de la vacante

ProductLife Group seeks a Senior Regulatory Affairs Consultant to lead regulatory engagements across biotechnology and pharmaceutical programs. The role spans from pre-IND through registration, shaping regulatory strategies and submission plans in collaboration with Clinical, CMC, and Quality teams.

The ideal candidate has 10–12 years in Regulatory Affairs, with experience in FDA interactions and global guidance, and a strong track record of delivering complex regulatory submissions.

Formación

• Develop and execute regulatory strategies for development programs.
• Coordinate multiple regulatory workstreams and submissions.
• Lead interactions with Health Authorities (FDA and others).
• Draft, review, and manage regulatory documents and briefs.
• Guide budgets, timelines and resource planning for programs.

Responsabilidades

• Lead regulatory projects from early development through approval.
• Prepare and manage Health Authority meeting packages and responses.
• Coordinate cross-functional teams (Clinical, CMC, Quality, Regulatory Operations).
• Support business development with regulatory capabilities and proposals.

Conocimientos

Regulatory strategy

Regulatory leadership

Cross-function collaboration

Project management

FDA interactions

Educación

Bachelor's degree in life sciences

Advanced degree / regulatory cert (preferred)

Descripción del empleo

## Senior Regulatory Affairs ConsultantApply: Remote: No Office - USA based: Full time: Posted 11 Days Ago: JR000040Make a meaningful impact on global healthcare — and grow your career while doing it. At ProductLife Group, you’ll join an innovative, forward‐thinking team operating across the world to shape the future of life sciences through expertise, collaboration, and purpose‐driven work.**Job Description :****ProductLife Group (PLG)** is a global life sciences consulting and outsourcing partner supporting pharmaceutical, biotechnology, and medical device companies throughout the full product lifecycle. We are looking for an experienced **Senior Consultant, Regulatory Affairs** to serve as a senior regulatory advisor and lead complex client 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 documentsSpecial designation requestsINDs, NDAs, BLAs, CTAs, and amendmentsResponses to Health Authority questionsRegulatory correspondence* Support, lead, or participate in formal interactions with Health Authorities on behalf of clients, including:Developing meeting strategiesPreparing and coaching clients for Health Authority meetingsServing 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 ### **Qualifications*** Bachelor's degree in life sciences, pharmacy, biology, chemistry, regulatory affairs, public health, or another relevant scientific discipline.* Advanced degree and/or regulatory certification is preferred but not required.* 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.Ready to take the next step? Apply today and join a global, innovative team that’s shaping the future of life sciences and empowering people to make a real impact in healthcare.