Senior Regulatory Affairs Consultant

Halloran Consulting Group, Inc; United States; Hybrid; USD 150.000 - 230.000; Vollzeit

Zusammenfassung

ProductLife Group (PLG) is a global life sciences consulting and outsourcing partner supporting pharmaceutical, biotechnology, and medical device companies. We seek a Senior Consultant, Regulatory Affairs to lead complex client engagements, from pre-IND through registration and marketing approval, coordinating with Health Authorities worldwide.

You will develop regulatory strategies, manage submissions, and guide cross-functional teams to meet milestones, ensuring compliance with FDA, ICH, and

Qualifikationen

• Bachelor's degree in life sciences, pharmacy, biology, chemistry, regulatory affairs, public health, or another relevant scientific discipline.
• Advanced degree 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 Health Authority interactions, including FDA and/or ex-U.S. agency meetings, briefing packages, responses, and regulatory correspondence.

Aufgaben

• 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, amendments, and responses to Health Authority questions.
• Support, lead, or participate in formal interactions with Health Authorities on behalf of clients, including meeting strategies and Authorized Sponsor Representative when required.
• Interpret and apply FDA, Health Canada, ICH, GxP, and global regulatory guidance and industry standards.
• Coordinate cross-functional client and internal teams across 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.

Jobbeschreibung

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 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 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.

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.

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. 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