Senior Regulatory Affairs Consultant

🕒 October 22

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 15%

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ProductLife Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💼 Consulting

🏥 Healthcare

💊 Pharmaceuticals

💰 GROWTH EQUITY VC on 2024-04

Consulting • Healthcare • Pharmaceuticals

ProductLife Group is a global life‑sciences consulting and outsourcing firm that pairs deep human expertise with intelligent automation to help bring therapies and health products from development to patient access. The company provides end-to-end solutions across product development (pre-clinical to approval), regulatory affairs, CMC & quality, clinical development, engineering and facility construction, market & patient access, safety and compliance, and digital & AI-enabled innovation. ProductLife Group serves biopharma, medtech and consumer health clients, operates a global network of offices covering 150+ countries, and highlights ~1,750 experts and ~10k+ submissions per year.

📋 Description

• Serve as a senior regulatory advisor and Regulatory Lead for biotechnology and pharmaceutical client engagements • 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, and regulatory correspondence • Support, lead, or participate in formal interactions with Health Authorities on behalf of clients • Develop meeting strategies and prepare and coach clients for Health Authority meetings • Serve 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 identify regulatory, operational, resourcing, timeline, and client-delivery risks • Develop risk-mitigation plans and communicate project status 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

🎯 Requirements

• Bachelor's degree in life sciences, pharmacy, biology, chemistry, regulatory affairs, public health, or another relevant scientific discipline • Advanced degree and/or regulatory certification preferred but not required • Minimum of 10–12 years of progressive Regulatory Affairs experience within biotechnology and pharmaceuticals, or life sciences consulting • 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

🏖️ Benefits

• Career growth opportunities • Opportunity to make a meaningful impact on global healthcare • Work with an innovative, forward-thinking global team • Purpose-driven work • Remote work arrangement

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