Senior Vice President, Global Regulatory Affairs

Job not on LinkedIn

🔥 26 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👔 Vice President

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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NewAmsterdam Pharma Corporation

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $175.3M Post IPO equity on 2024-03

Healthcare • Biotechnology • Pharmaceuticals

NewAmsterdam Pharma Corporation is a clinical-stage biopharmaceutical company focused on developing therapies for cardiovascular disease and other lipid-related conditions. The company is advancing obicetrapib, a CETP inhibitor, and other programs aimed at lowering LDL-C and reducing cardiovascular risk for patients who have unmet needs despite existing lipid-lowering treatments. NewAmsterdam emphasizes science-backed development, clinical trials, and patient-focused initiatives.

📋 Description

• Develop US and global regulatory strategies aligned with business objectives • Provide guidance, direction, and leadership on regulatory strategies to the development team and senior management • Make strategic contributions to clinical development plans • Lead the regulatory team in providing expert advice to development teams and operationalizing key regulatory activities • Identify talent growth opportunities and forecast team capability needs as the pipeline evolves • Prepare meeting requests and briefing documents, coordinate and prepare teams for meetings, and serve as the primary liaison with regulatory authorities • Maintain working knowledge of US and EU laws, regulations, guidelines, and the global regulatory environment • Identify and collaborate with regulatory experts and consultants • Coordinate and prepare responses to requests for information from regulatory authorities • Represent Regulatory Affairs on cross-functional development teams • Establish, update, and implement regulatory policies, standards, and procedures • Lead global regulatory strategy across late-stage development, launch readiness, product registration, and post-approval lifecycle management • Partner with Commercial, Medical Affairs, Legal/Compliance, Quality, Pharmacovigilance, Supply Chain, and Market Access on launch readiness, compliant communications, labeling, and lifecycle planning • Ensure regulatory operations comply with FDA, EU, ICH, EMA, and industry standards • Manage regulatory aspects of products and projects, including timelines and deliverables • Guide electronic regulatory submissions and support development teams in their preparation • Author, review, and edit informed consents, Investigator’s Brochures, study materials, essential documents, presentations, and reports • Work with the selected EU Designated Person to ensure Good Distribution Practices of API • Report to the Chief Medical Officer

🎯 Requirements

• Advanced degree preferred • 15+ years of regulatory experience • Minimum of 10 years of experience in a senior leadership role • Demonstrated leadership competencies in establishing clear direction and objectives; ability to simplify complex processes and foster an environment that brings out the best in people • Experience leading a team of regulatory professionals and external partners, with a preference for leading a team through stages of company expansion • Excellent working knowledge of drug development process and understanding of regulatory environment across USA, EU, and other regions • Demonstrated experience leading regulatory strategy for late-stage, launch, and commercial-stage products in the US and ex-US markets • Experience with post-approval regulatory activities, including labeling strategy, safety-related updates, CMC changes, post-approval commitments, renewals, and supplements/variations • Proven ability to advise executive and commercial leadership on regulatory risks affecting launch timing, market access, labeling, competitive positioning, promotional strategy, and lifecycle management • Ability to provide strong regulatory leadership on a cross-functional team • Advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to drug development • Excellent listening, communication, and interpersonal skills, with a track record of fostering team collaboration and consistently delivering high-quality work • Ability to accurately project timelines and manage them across regulatory projects

🏖️ Benefits

• Annual bonus • Long-term incentives • Health insurance • Dental and vision coverage • Term life and disability coverage • Retirement plans • Remote position • Travel required as determined to meet business requirements