Senior Regulatory Affairs Consultant

Make 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.

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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.

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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.

An international career, built around you

PLG partners with Life Sciences innovators to bring new medicines and technologies to patients, faster. Join a fast-growing, entrepreneurial company where your expertise makes a difference from day one.

Why PLG is the place to work

• A path for every career stage, from graduate to senior expert
• Exciting, high-impact projects with leading life sciences clients
• International by design
• Hybrid & flexible working
• Continuous learning
• An inclusive & diverse culture