VP Regulatory Strategy & Submissions (FDA)
Clinical Dynamix
Clinical Dynamix, Inc. seeks a Vice President of Regulatory Strategy to lead regulatory planning and submissions from pre-submission to approval. You will drive regulatory strategy across product candidates and collaborate with R&D, quality, operations, and legal to ensure compliant, timely approvals.
The role includes exposure to US FDA leadership, global regulatory strategy, and oversight of IP activities with cross-site manufacturing teams. Strong leadership and strategic vision are essential.
#J-18808-Ljbffr- ...Role Overview The Vice President of Regulatory Strategy is responsible for providing regulatory... ...planning and oversight of all regulatory submissions from pre submission to approval.... ...the main contact point in the US for the FDA and will also be responsible for the development...RegulatoryContract workLocal area
- ...) in Morristown, NJ. This executive will lead medical affairs strategy across development and marketed products in a highly matrixed... ...recruit and coach teams, and engage with KOLs to inform strategy while maintaining the highest ethical and regulatory #J-18808-LjbffrRegulatory
$419.29k
...nationally recognized healthcare system. The VP leads transformation across sourcing,... ...leadership, the VP ensures that supply chain strategy is fully aligned with AH’s clinical,... ...vendor risk and ensuring compliance with regulatory and organizational standards. Technology...RegulatoryContract work$100k - $230k
...Senior Vice President, Medical Strategy - Ogilvy Health Parsippany, New Jersey OGILVY HEALTH: WE INSPIRE PEOPLE AND BRANDS TO... ...Working knowledge of clinical or preclinical research principles, regulatory affairs, and biostatistics ~ Line management history...RegulatoryFor contractors$100k - $230k
...Role We are looking for a creatively driven integrated Medical Strategy professional to work across a portfolio of well-known... ...Working knowledge of clinical or preclinical research principles, regulatory affairs, and biostatistics Line management history supervising...RegulatoryWorldwide- Shionogi Inc. in Florham Park, NJ, seeks a Regulatory Program Support professional to manage end-to-end submission delivery, planning, and cross-functional coordination across development programs and marketed products. The role partners with the global regulatory lead,...Regulatory
$343.69k
...The VP, Protective Services and Emergency Management provides strategic leadership and... ...practices that align with healthcare regulatory requirements and industry standards. Strategic... ...a comprehensive, systemwide security strategy aligned with Atlantic Health System’s...RegulatoryLocal area$150k - $175k
...helping organizations manage risk, ensure regulatory compliance, and protect their brands at... ...consumers across any channel.TL;DRWe’re hiring a VP, Strategic Accounts to own the... ...team as it grows.WHAT YOU’LL DOLeadSet the strategy, segmentation, and coverage model for a select...RegulatoryContract workRemote work$250k - $310k
...around the world.Position SummaryThe VP, Commercial & G&A IT owns the technology strategy, systems, and delivery... ...standards while accommodating local regulatory needs (e.g., GDPR, regional labor... ...systems.Maintain working knowledge of FDA requirements relevant to a...RegulatoryFull timeContract workLocal areaWorldwide- ...US Advertising and Promotion within Global Regulatory Affairs to lead day-to-day decisions and... ...Cambridge, MA. You will develop regulatory strategies for promotion and labeling, oversee day-to-day activities, and liaise with FDA while mentoring staff and coordinating...Regulatory
- ...Barclays is seeking a Senior Vulnerability Management SME – VP to strengthen our cyber risk posture by identifying and helping remediate... ...vulnerability discovery aligned with a threat-informed defense strategy. This role is based in Whippany, NJ and commands a substantial...
- ...lead the development and execution of comprehensive marketing strategies across a growing pharmaceutical portfolio. The ideal candidate... ...actionable plans while collaborating with Sales, Medical Affairs, Regulatory, and cross-functional teams. Responsibilities include leading...Regulatory
- ...with pharma experience to shape launch plans and brand narratives. You will lead cross-functional teams, translate insights into strategy, and craft compelling briefs that drive client outcomes. The ideal candidate has 8+ years in brand strategy within pharmaceuticals...Flexible hours
- ...analyzing studies, providing statistical leadership, and contributing to HTA submissions for multiple therapeutic areas. Strong background in biostatistics, real-world evidence, and regulatory-driven research is required. Applicants should have an MS or PhD in statistics...Regulatory
- ...Interim VP, Regulatory Affairs ~ Interim VP-level Regulatory Affairs consultant to provide senior strategic and hands-on... ...priorities across development programs, lead preparation for FDA interactions and key submissions, advise cross-functional teams on regulatory decisions...RegulatoryPart timeInterim role
- ...Director to lead the Scientific Services team within the Medical Strategy and Communications division. You will oversee high-quality... ...oncology space, guiding medical communications strategy through regulatory challenges. The role emphasizes leadership of medical...Regulatory
- ...engineering across a broad portfolio of drug delivery devices and combination products. You will guide strategy, oversee studies, and ensure alignment with regulatory expectations, while mentoring the HF/UE team and shaping cross-functional processes. You will...Regulatory
- Sarepta Therapeutics is seeking a Regulatory Affairs Lead to guide clinical trial activities, review CRO submissions, and support regulatory strategy across markets. This US-based remote role requires collaboration with cross-functional teams and a strong emphasis on timely...RegulatoryRemote job
- Daiichi Sankyo US in New Jersey seeks a Global Regulatory Lead to shape regulatory strategy for development programs and represent regulatory in GPT meetings. You will guide submissions, align regional plans, and ensure Health Authority alignment across global programs...Regulatory
- ...Management to lead a team of project managers and align programs with organizational goals. You will guide resource allocations, shape strategies, and drive performance across the agency's health and wellness initiatives. The role requires senior leadership experience,...
$90k - $180k
...leader to serve as our Director, Decision Sciences & Audience Strategy. In this role, you’ll sit at the intersection of advanced analytics... ...solutions remain aligned with client needs, data ethics, and regulatory requirements.Promote sound technical standards, methodological...Regulatory$150k - $200k
...people. Every essence of you enriches our world. We are Givaudan. Human by nature. Join us as our next Head of Systems Strategy – Regulatory, reporting to our Global Head of Regulatory Compliance & Digital Strategy. We are looking for an experienced Solution Lead...Regulatory- ...focused firm, seeks a medical writing expert to direct the development and implementation of the medical communication strategy for regulatory submissions across assigned drug projects. You will collaborate with Senior Medical Writers and Submission team experts to shape...Regulatory
- ...Hanover, NJ is seeking a visionary leader to spearhead nutrition strategy and its deployment across the US and Canada. You will lead a... ...claims, communications, and product design. Collaborate with regulatory, marketing, science affairs, and external partners to advance...Regulatory
- ...through the complete overview below.Job Title: Manager, Congress Strategy & Orchestration (CS&O)Location: East Hanover, NJ (Hybrid)... ...Relationship (CMAR), agency partners, Medical Affairs, Legal, Regulatory and Compliance. The Manager helps integrate functional strategies...Regulatory
- ...role in new business development, including prospecting, pitch strategy, and presentation leadershipIdentify opportunities to expand... ...and guide communications strategies around clinical milestones, regulatory events, product approvals, launches, and post-launch...Regulatory
$170k - $240k
## VP, Product CounselApply: Hybrid: Morristown, NJ: Full time: Posted Yesterday: R4917## **Job Description****Are you looking for... ...including policy drafting, coverage analysis, product development, regulatory considerations, and underwriting support. This position offers...RegulatoryFull timeWork at officeFlexible hours- ...Barclays in Whippany, NJ is seeking a Prime Services Negotiator VP to draft, negotiate and execute capital markets contract documentation... ...agreements, advising senior stakeholders on risk and regulatory matters. This role requires legal analysis, strong communication...RegulatoryContract work
- ...abbvie on LinkedIn, Facebook , Instagram , X and YouTube. The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market...RegulatoryWorldwide
- ...sciences communications, is seeking a Director of Omnichannel Strategy & Engagement to lead integrated digital strategy and customer... ...strategies align with customer journeys, brand objectives, regulatory requirements, performance KPIs, and ROI expectations. Identify...RegulatoryFull time
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