Senior Regulatory Affairs Consultant, CMC

🕒 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

• 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 across Clinical, CMC, and Nonclinical functions, 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 packages, special designation requests, and regulatory submissions including INDs, NDAs, BLAs, and amendments • Lead and represent clients in formal FDA interactions • Act as Authorized Sponsor Representative • Prepare and coach clients for Health Authority meetings • Interpret and apply FDA regulations, ICH guidelines, and global regulatory frameworks • Define scope, timelines, budget, and resource plans for complex regulatory programs • Monitor risks and mitigation strategies • Communicate project status to clients and internal stakeholders • Support business development through proposal and SOW development • Develop new consulting offerings • Publish articles and present at conferences or workshops • Contribute to process optimization initiatives • Mentor and guide internal team members in direct, matrixed, or project-based environments

🎯 Requirements

• Bachelor’s degree (BA/BS) in a relevant scientific discipline • 10–15 years of Regulatory Affairs experience with strong U.S. FDA exposure • Experience independently developing and executing U.S. FDA regulatory strategies • Experience authoring and leading INDs, NDAs, BLAs, amendments, and Health Authority meeting packages • Experience with direct Health Authority interactions as Sponsor Representative • Strong working knowledge of FDA regulations and guidance • Strong working knowledge of ICH guidelines • Strong working knowledge of global regulatory frameworks • Demonstrated cross-functional regulatory leadership • Experience across multiple development stages, from early development through registration • Strong regulatory intelligence and precedent-based decision-making • Solid project management skills, including timeline ownership for complex programs

🏖️ Benefits

• Career growth opportunities • Opportunity to make a meaningful impact on global healthcare • Innovative, forward-thinking, purpose-driven work environment • Collaboration with global teams • Mentoring and guidance opportunities

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