Senior Regulatory Affairs Consultant, CMC

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.

‎‎

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 Regulatory Affairs Strategy Expert (Senior Consultant) to lead U.S. regulatory strategy and execution for biotechnology and pharmaceutical clients, primarily in the pre-market phase of development across drugs and biologics.

This is a client-facing leadership role where you will act as a trusted regulatory advisor, program lead, and strategic partner, working closely with U.S. FDA and cross-functional client teams.

Responsibilities

• Provide regulatory strategic and tactical leadership for biotech and pharma programs across development stages
• Serve as Regulatory Lead / Advisor and project or program leader for multiple client engagements
• Lead cross-functional teams (Clinical, CMC, Nonclinical) across multiple indications and product types
• Develop and drive regulatory strategies, integrated development plans, and key regulatory documents
• Coordinate, author, review, and manage:Health Authority meeting packagesSpecial designation requestsRegulatory submissions (INDs, NDAs, BLAs, amendments)
• Lead and represent clients in formal FDA interactions, including:Acting as Authorized Sponsor RepresentativePreparing and coaching clients for Health Authority meetings
• Interpret and apply FDA regulations, ICH guidelines, and global regulatory frameworks
• Act as project lead on complex, multi-disciplinary regulatory programs:Define scope, timelines, budget, and resource plansMonitor risks and mitigation strategiesCommunicate project status clearly to clients and internal stakeholders
• Support business development activities, including proposal and SOW development
• Contribute to internal initiatives such as:Developing new consulting offeringsPublishing articles and presenting at conferences or workshopsProcess optimization initiatives
• Mentor and guide internal team members in direct, matrixed, or project-based environments

Qualifications

• Bachelor’s degree (BA/BS) in a relevant scientific discipline
• 10–15 years of Regulatory Affairs experience, with strong U.S. FDA exposure
• Proven experience in:Independent development and execution of U.S. FDA regulatory strategiesAuthoring and leading INDs, NDAs, BLAs, amendments, and HA meeting packagesDirect Health Authority interactions as Sponsor Representative
• Strong working knowledge of:FDA regulations and guidanceICH guidelinesGlobal regulatory frameworks
• Demonstrated cross-functional regulatory leadership
• Experience across multiple development stages (early development through registration)
• Strong regulatory intelligence and precedent-based decision-making
• Solid project management skills, including timeline ownership for complex programs

‎

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