Global CMC Regulatory Leader Senior Advisor
BioSpace, Inc.
Lilly, headquartered in Indianapolis, invites applications for Advisor/Sr. Advisor - Global Regulatory Affairs (GRA) – CMC Platform Regulatory Scientist. This role provides global regulatory strategies and technical CMC support across modalities for clinical trials, market registrations, and post-approval activities. Location: Indianapolis or Boston (hybrid). Responsibilities include developing global CMC regulatory strategies, leading preparation of CMC submissions, guiding cross-functional #J-18808-Ljbffr
$212k - $333.19k
...empower you to shine? Join us as a Senior Director, Global Program Leader - Oncology, Solid Tumors in our Cambridge... ...to simultaneously driving regulatory approval as well as launch and global... ...Commercial Subteam, Pharmaceutical Sciences (CMC) Subteam, etc. to the GPT through...SeniorRegulatoryMinimum wageWork at officeLocal areaRemote workNight shift$237.7k - $356.5k
Job DescriptionGeneral Summary:The Senior Director, CMC Product Leader (T1D) will lead the Chemistry, Manufacturing... ..., technology transfer, validation, regulatory submission, and commercialization... ...requirements, quality systems, and global regulatory expectations relevant to...SeniorRegulatoryFull timeSummer workRemote workFlexible hours2 days per week$237k
...Vertex Pharmaceuticals seeks a Senior Director to lead Chemistry, Manufacturing... ...involves developing integrated CMC plans across development, scale-up, regulatory submission, and commercialization... ...requirements, quality systems, and global regulatory standards for cell...SeniorRegulatory- ...Safety Scientist to provide strategic safety leadership within Global Patient Safety. You will lead safety data reviews, author safety... ...key documents, and manage global aggregate safety reports for regulatory agencies. The role requires a Bachelor's in a biological/medical...SeniorRegulatory
- ...Eastridge Workforce Solutions is seeking a Senior Regulatory CMC Lead to provide strategic Regulatory CMC leadership for a global biologics program. This role will lead CMC activities supporting global BLA/MAA submissions, with a focus on Module 3, global regulatory strategy...SeniorRegulatoryLocal areaRemote work
- ...seeking an experienced Medical Director, Senior Safety Physician to provide medical... ...safety information to stakeholders. In a global, cross-functional environment, you will... ...collaborate across Clinical Development, Regulatory Affairs, Safety Science, Medical Affairs...SeniorRegulatory
$145 - $170 per hour
...see how Eastridge can help you find your next opportunity. Senior Regulatory CMC Lead Compensation: $145.00 - $170.00 Loading... Eastridge... ...a Senior Regulatory CMC Lead to support our client’s global Regulatory Affairs team. Created/Revised Date : September...SeniorRegulatoryHourly payFull timeTemporary workLocal areaRemote workMonday to FridayShift work- ...Centessa Pharmaceuticals is seeking a Senior Director, Regulatory CMC in the US to provide strategic and operational leadership for Regulatory CMC activities across small molecule programs. You will drive regulatory readiness, oversee submissions, and manage external partners...SeniorRegulatory
- Relay Therapeutics is recruiting for an Associate Director/Director, CMC Regulatory in Cambridge, MA. You will lead regulatory CMC strategies for small molecule programs, develop global submission plans, and coordinate cross-functional teams to ensure regulatory success...SeniorRegulatory
- ...Job Description Job Description Primary Responsibilities 1. Global Regulatory CMC Strategy Lead and drive the global Regulatory CMC strategy for biologic ADC programs. Provide strategic guidance for global MAA/BLA preparation and submission activities. Ensure...SeniorRegulatoryWork at officeRemote workFlexible hours
- ...Takeda's Global Regulatory Affairs - CMC team in Cambridge, MA is seeking a Regulatory CMC professional to lead regulatory submissions for investigational, registration and post-approval programs across global markets. With minimal supervision, you will define CMC content...Regulatory
- ...periodic Boston presence, focusing on business development and client liaison. Ideal candidates will have 15+ years in Pharma/Biotech with direct exposure to Quality, Manufacturing, Regulatory, or Supply Chain roles, and a Bachelor’s degree in a science. #J-18808-Ljbffr...SeniorRegulatoryFull timeRemote work
- Moderna is seeking an Associate Director, Global Regulatory Affairs, CMC, to lead and oversee regulatory activities for CMC and Quality, coordinating worldwide submissions and agency communications. The role requires 10+ years in pharma/biotech with strong EU/ROW regulatory...RegulatoryWork at officeWorldwide
$212k - $333.19k
...is to accelerate access to transformative medicines and make a lasting impact on patients worldwide.Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part of the global regulatory team. In this influential role, you will lead a top-...SeniorRegulatoryMinimum wageLocal areaRemote workWorldwide- ...ready to be at the forefront of medical innovation? As the Senior Global Medical Affairs Leader for MASH, you'll play a pivotal role in shaping the... ...requires a deep understanding of healthcare system pathways, regulatory landscapes, market access, and competitive dynamics....SeniorRegulatoryFull timeWorldwideRelocation package
- ...Moderna seeks an Associate Director of Global Regulatory Affairs, CMC, to lead LATAM regulatory activities and ensure high-quality CMC submissions. This role oversees agency communications, and regulatory applications, coordinating cross-functional teams in a fast-paced...Regulatory
- ...Senior Director, Global Regulatory Lead, GI & Inflammation About the role: The Global Regulatory Leads, Senior Director is responsible for ensuring that the organization gains regulatory approval for new products and product amendments, while maintaining the currency...SeniorRegulatoryFull timeLocal area
$212k - $333.19k
...DescriptionAbout the role:The Senior Director, Oncology Search &... ...translating scientific, clinical, regulatory, and competitive insights... ...and asset value creation.This leader will drive cross-functional... ...to lead in a highly matrixed global environment. You will report...SeniorRegulatoryMinimum wageLocal areaRemote work- Job-ID32387836Reference26-00886 Job Description: This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as follows: This role is within...SeniorRegulatory
$307k - $325.35k
...worldwide. The Opportunity The Senior Director/Vice President, Program Team Leader is the single point of... ...and beyond. Integrate clinical, regulatory, CMC, nonclinical, safety, commercial... ...development stages. ~5+ years leading global cross-functional program,...SeniorRegulatoryWorldwideShift work- ...Title: Director / Senior Director, Global Regulatory Lead Location: San Francisco, CA or Boston, MA - hybrid 3-days per week (relocation offered!) Overview... ...readiness Partner cross-functionally with Clinical, CMC, Commercial, and Executive Leadership teams Act as the...SeniorRegulatoryRelocation3 days per week
$210k - $320k
...motivated Sr. Director / Director of CMC, to lead our advancing... ...a subject matter expert, this leader will be accountable for all CMC... ...suppliers.Work directly with regulatory and key stakeholders on the development... ...review of CMC sections for global regulatory submissions...SeniorRegulatoryFull time$210k - $320k
...suffering from serious diseases.Position Overview: The Regulatory Director/Sr. Director Regulatory CMC will be responsible for preparing CMC and Quality... ...regulatory compliance support for the development of global products. This position will lead regulatory activities...SeniorRegulatoryFull timeShift work3 days per week1 day per week$142.5k - $256.5k
The RoleThe Global Regulatory CMC Lead will be responsible for coordinating regulatory CMC activities for one or more products, depending on complexity, through all stages of a products lifecycle. The Lead will be responsible for developing global regulatory CMC strategies...RegulatoryPermanent employmentFull timeWork at officeWork from home- ...Moderna Therapeutics is seeking an Associate Director of Global Regulatory Affairs, CMC, to oversee CMC and Quality agency correspondence and regulatory applications for global products. You will lead regulatory activities, ensure high-quality CMC sections, and manage...RegulatoryWork at office
$122.25k - $176.58k
Job Title: CMC Demand & Supply LeaderLocation: Framingham, MAAbout... ...Within CMC function, in the Global CMC Project Management department... ...of the Demand & Supply Leader is to integrate Project Strategy... ...execution of Projects in respect to Regulatory and Quality requirements. This...RegulatoryFull time$195k - $330k
...you’ll make an impact:Lead the development and execution of global regulatory CMC strategies for degrader programs across all stages of development... .../supplements.Provide strategic regulatory CMC guidance to senior leadership regarding health authority interactions,...SeniorRegulatory- ...Biostatistics in Boston to lead statistical activities across assets and indications within the Global Biometrics Department. You will collaborate with clinical, regulatory, and evidence generation stakeholders to ensure regulatory relevance and scientific validity....SeniorRegulatory
$195k - $330k
...How you’ll make an impact:Drive end-to-end CMC program management for mid to late-stage... ..., drug product, analytical, quality, regulatory, and supply chain workstreams.Support planning... ...on-time delivery of CMC components for global regulatory filings, in partnership with Regulatory...SeniorRegulatory$175k - $260k
...Great Place to Work in 2026. Description Of Role As the Senior Director, Regulatory CMC, you will provide strategic and operational leadership for... ...will lead Regulatory CMC initiatives, develop and execute global CMC regulatory strategies, partner with internal and...SeniorRegulatoryFull time
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global CMC Regulatory Leader Senior Advisor. Be the first to apply!




