Director, Global CMC Regulatory Strategy
Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated seeks a Director of Chemistry Manufacturing Controls (CMC) to lead a Regulatory CMC team responsible for global regulatory strategies across a small molecule portfolio. You will guide content for submissions, engage Health Authorities, and drive digital and AI-enabled regulatory capabilities to enhance decision-making, documentation, and submission execution. The role emphasizes strategic leadership, talent development, and cross-functional collaboration to #J-18808-Ljbffr Vertex Pharmaceuticals Incorporated
$154.4k - $242.55k
...to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute... ...investigational, registration and/or post-approval strategies for assigned products. RA CMC member on the...RegulatoryMinimum wageTemporary workLocal areaRemote workWorldwide$142.5k - $256.5k
The Role:The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory CMC activities for one or more products,... ...will be responsible for developing global regulatory CMC strategies and collaborating with key stakeholders to execute the strategies...RegulatoryPermanent employmentFull timeWork at officeWork from home- ...company in Cambridge, MA, seeks an experienced Associate Director of Regulatory Strategy to lead oncology therapeutic programs. This role requires... ...particularly in oncology, to ensure alignment between US and global strategies. Exceptional communication skills and...Regulatory
$142.5k - $256.5k
Role Overview The Associate Director, Global Regulatory-CMC will coordinate regulatory CMC activities for one or more products throughout their lifecycle, develop global regulatory CMC strategies, collaborate with stakeholders, and manage multiple projects to support the...Regulatory- Takeda's Plasma-Derived Therapies (PDT) R&D Organization in Cambridge, MA is seeking a Global Regulatory Labeling Strategy Lead (Associate Director) to steer labeling strategy across US and EU. You will work with Clinical, Pharmacovigilance, Legal, and Commercial teams...Regulatory
- Overview Moderna Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the oncology franchise in one of... ...vaccines based on messenger RNA technology in the US and other global markets. Responsibilities Serve as the global...Regulatory
$190.4k - $285.6k
...DescriptionGeneral Summary:The Director, Global Submission Management (GSM)... ...of a portfolio of global regulatory submissions across development... ...with global regulatory strategies and operational objectives.... ...Regulatory Strategy, Regulatory CMC, Labeling, Publishing, and Advertising...RegulatoryFull timeSummer workRemote workFlexible hours2 days per week$166.4k - $249.6k
Job DescriptionGeneral Summary:The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and commercial products focusing on biologics. This role is accountable for authoring, reviewing, and...RegulatoryFull timeSummer workRemote workFlexible hours2 days per week$177k - $308k
...better for people around the world. We are a global healthcare leader headquartered in... ...committed to using its innovation-based strategy to discover, develop and deliver innovative... ...while ensuring scientific rigor, regulatory defensibility, and meaningful value creation...RegulatoryFull timeFlexible hours$180k - $245k
...seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our... ...and executing regulatory strategies that support global product development... ...background is preferred. CMC experience is a plus.ResponsibilitiesDevelop...Regulatory$170.9k - $231.3k
Overview The Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementating global CMC regulatory strategies for development-stage programs. This role will play a critical part in shaping regulatory strategies for emerging therapeutic...RegulatoryFull timeTemporary workWork at officeLocal areaFlexible hours- Moderna is seeking an Associate Director, Global Regulatory, CMC to coordinate regulatory CMC activities across product lifecycles and develop global strategies in alignment with business priorities. You will guide product teams and prepare CMC/Quality regulatory submissions...Regulatory
- Moderna seeks an Associate Director, Global Regulatory-CMC in Norwood, Massachusetts. This role involves coordinating regulatory CMC activities and developing strategies for transformative medicines. The ideal candidate will have at least 8 years in the biotech space,...Regulatory
- Moderna is seeking an Associate Director, Global Regulatory-CMC to coordinate regulatory CMC activities across product lifecycles, develop global CMC strategies, and guide product teams in preparing agency correspondence and regulatory applications. The role leads interactions...Regulatory
- ...Alnylam Switzerland GmbH in Cambridge, MA is seeking an Associate Director, Regulatory Affairs CMC to lead the development and execution of global regulatory strategies for innovative therapeutics, particularly in CMC Development. This role combines scientific expertise...Regulatory
$162.8k - $220.2k
Overview:The Associate Director, Supply Network Strategy Operations is responsible for driving disciplined... ...and supply chain flows, including CMC, regulatory and quality considerationsMust be... ...commitment to people. We're proud to be a globally recognized top employer, where an...RegulatoryFull timeTemporary workLocal areaFlexible hours- ...develop & advocate strategic positions for CMC regulatory/CMC issues with cross functional... ...to our staff to develop robust product strategies that integrate CMC regulatory policy and... ...emerging regulatory CMC trends across global markets, ensuring proactive regulatory...RegulatoryFull timeLocal area
- Lilly is seeking an experienced Regulatory CMC leader to develop and implement global CMC strategies for gene therapy programs. You will lead the preparation of CMC sections for IND/CTA, BLA/MAA submissions and serve as the primary liaison with major health authorities...Regulatory
$200k - $265k
...create an unparalleled, direct impact.The OpportunityLeads the global regulatory strategy, submission planning, and health authority engagement for... ...and documents, including clinical, non-clinical, and CMC development documentation as neededQualificationsKnowledge...RegulatoryFull timeTemporary workWork experience placementWork at officeWorldwide- Akebia Therapeutics seeks a Director, Regulatory Affairs - Labeling to shape global labeling strategy across our portfolio. You will serve as the enterprise expert on labeling... ...Medical Affairs, Commercial, Legal, Safety, and CMC to ensure robust, compliant labeling. This...Regulatory
- Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC - Biologics to lead regulatory science for biologics assets across the development lifecycle. You will drive global CMC strategy, author submissions, and coordinate with Process Development, Analytical...Regulatory
- ...is seeking a Chemistry Manufacturing Controls Manager to lead regulatory CMC activities for both investigational and commercial products. The role involves reviewing CMC sections, developing global strategies, and coordinating with cross-functional teams to ensure...Regulatory
$173k - $285.33k
...What You'll Do As a Director/Senior Director, CMC Drug Substance Development... ...development and manufacturing strategy to produce drug substances... ...substance sections of regulatory documents. You will: Lead... ...Screen, select, and manage global external partners for process...Regulatory- Vertex is seeking an Associate Director of CMC to lead global regulatory strategies for biologics, author submissions, and interface with health authorities, leveraging AI-enabled tools to enhance document quality and efficiency. This role requires 8+ years in pharma/biotech...Regulatory
- ...development phases. You will ensure GMP-compliant, cost-effective delivery of investigational products to global sites and partner with Clinical Operations, Quality, Regulatory, and external vendors. The ideal candidate has 10+ years in pharmaceutical/biotech supply chain,...Regulatory
- Associate Director, Regulatory Affairs CMC (Project Management) Job Description Company Overview Founded... ...and implement innovative Regulatory strategies where little precedent exists. You will... ...in close collaboration with CMC and global development teams, and with relevant...RegulatoryContract workRemote work
- ...the IT solutions roadmap for CMC digital transformation. Oversee... .../ML capabilities for faster regulatory authoring and reduced error... ...lifecycle of CMC applications (strategy/design through deployment,... ...TCO. Ensure GxP/data integrity/global regulatory compliance and audit...RegulatoryFlexible hours
- ...Role: As Associate Director, AS&T Projects & Strategy, you will play a key role... ...cross-functional late-stage CMC team, helping drive... ...collaboration with functions such as Regulatory Affairs, CMC, and Quality,... ..., cross-functional, and global team environments. •...RegulatoryHourly pay
$167k - $300.7k
...seeking a dynamic and experienced Director, CMC Stability to lead an end-to-... ...stability and shelf-life strategies, design stability studies... ...enable timely CMC decisions, regulatory filings, and product... ...modalities.Strong knowledge of global stability expectations and guidance...RegulatoryPermanent employmentFull timeWork at officeWork from home$252k - $378k
...Summary:The Medical Affairs Senior Director provides medical and... ...that scientific and medical strategies are aligned with broader corporate... .../regional insights with global teams to ensure global medical... ...understanding of global medical, regulatory and commercial (including...RegulatoryFull timeSummer workLocal areaRemote workFlexible hours2 days per week
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