Global Regulatory CMC Lead
Hydrogen Group
A global healthcare firm is seeking a Regulatory CMC Lead in Boston, MA. The role requires expertise in regulatory strategy, operations, and planning for CMC aspects of assigned projects. Candidates should possess strong communication skills and a minimum of 3-5 years in the pharmaceutical industry. Responsibilities include managing Health Authority interactions and leading cross-functional teams. This position is vital for ensuring successful product submissions and regulatory compliance. #J-18808-Ljbffr Hydrogen Group
- A public Biotech company in Boston is seeking a Regulatory Affairs CMC Manager/Senior Manager to support biologic products' global development and registration. The ideal candidate will lead the submission of regulatory documentation, ensuring compliance with FDA and EMA...Regulatory
- Rhythm Pharmaceuticals Inc. in Boston, MA seeks an experienced Regulatory CMC professional to drive high-quality regulatory chemistry, manufacturing, and controls deliverables. You will support global filing strategies, coordinate with Global Regulatory Affairs, Technical...Regulatory
- Takeda seeks an accomplished GRA CMC Franchise Lead in Boston to independently develop and execute regulatory CMC strategies for TAK-079 across clinical development and... ...Development and Commercial teams to drive major global submissions and ensure regulatory compliance....Regulatory
- Takeda seeks an experienced GRA CMC leader to drive regulatory strategies and submissions across global programs. You will lead CMC aspects of registrational submissions, coordinate with development teams, and ensure regulatory compliance throughout product lifecycles....Regulatory
$177k - $278.08k
...to patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to... ...as follows: You will be the GRA CMC Franchise Lead for TAK-079 Independently develops the regulatory...RegulatoryMinimum wageFull timeTemporary workLocal areaRemote workWorldwide- ...Katalyst CRO in Boston is seeking a Regulatory Affairs professional to lead CMC strategies for investigational products. The candidate will interact with Health Authorities and manage regulatory submissions to ensure compliance and success. With a foundation in regulatory...Regulatory
$170k - $220k
A genetic medicine company in Boston is seeking an Associate Director of Regulatory CMC to lead regulatory strategy and bridge development with regulatory roles. This hybrid position requires strong regulatory affairs experience in biotechnology, excellent communication...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, particularly...Regulatory
- CRISPR Therapeutics, Inc. is seeking an Associate Director, Regulatory Affairs CMC to lead regulatory CMC efforts for a portfolio of gene-based... ...complex CMC topics, prepare high-quality submissions, and guide global teams through INDs, CTAs, #J-18808-Ljbffr Crispr...RegulatoryContract workWorldwide
- ...Pharmaceuticals is seeking an Associate Director, CMC Quality Compliance and Inspection... ...CAPA closures. The position demands deep regulatory knowledge, experience with multiple... ...enabling continuous operational excellence in a global #J-18808-Ljbffr Vertex PharmaceuticalsRegulatory
- Beeline Medicines seeks a Senior Director, Regulatory Affairs CMC - Biologics to lead regulatory science for biologics assets, including monoclonal antibodies... ...external CMOs to align with FDA/EMA expectations and global health authority standards. The role requires deep CMC...Regulatory
- 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
$212k - $333.19k
...to shine? Join us as a Senior Director, Global Program Lead- Neuroscience in our Cambridge, MA... ...leadersCommitted to simultaneously driving regulatory approval as well as launch and global patient... ...Subteam, Pharmaceutical Sciences (CMC) Subteam, etc. to the GPT through...RegulatoryMinimum wageTemporary workWork at officeLocal areaRemote work- Hongene Biotech is seeking an Associate Director / Senior Manager in CMC Project Management in the Boston area. The role reports to the VP, Global Head of CMC & Regulatory and strengthens project management for oligonucleotide contract manufacturing services. Senior/AD...RegulatoryContract work
- 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
- Vertex Pharmaceuticals Inc is seeking a Director of Chemistry Manufacturing Controls (CMC) to lead a Regulatory CMC team responsible for global regulatory strategies and submissions across small molecule programs. The role emphasizes strategic leadership, Health Authority...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
$211.5k - $258.5k
Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading the integrated global regulatory strategies... ...assigned programs, ensuring alignment with clinical, CMC, and non-clinical development activities and overall program...RegulatoryLocal areaFlexible hours2 days per week$238k - $374k
...changing therapies to patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product, you will... ...(e.g., US, EU, UK, Japan, China).How you will contribute:Leads and develops a team of regulatory leaders and subject matter...RegulatoryMinimum wageTemporary workWork at officeLocal areaRemote workWorldwide$238k - $374k
...the best of my knowledge.Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you looking for a patient-focused... ...major regions (e.g., US, EU, Japan, China).ACCOUNTABILITIES Leads and develops a team of regulatory leaders and subject matter...RegulatoryMinimum wageTemporary workLocal areaRemote work- ...CRISPR Therapeutics, based in Boston, is seeking an Associate Director for Regulatory Affairs CMC to oversee regulatory strategies for innovative gene therapies. This leadership role requires extensive experience in CMC regulatory requirements for biologics and gene therapies...RegulatoryRemote workFlexible hours
- A biopharmaceutical company in Boston is seeking a Regulatory Affairs Specialist to coordinate the preparation of regulatory submission packages... ...with Small Molecule drugs, and a strong understanding of CMC requirements. Key responsibilities include managing submissions...Regulatory
- A leading pharmaceutical company in Cambridge is seeking a Senior Director, Global Regulatory Lead for GI & Inflammation. This role is critical in ensuring compliance and securing regulatory approvals for new products. The ideal candidate will have over 12 years of experience...Regulatory
$177k - $278.08k
...to accelerate access to transformative medicines and make a lasting impact on patients worldwide.Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the global regulatory team. As Director, Global Regulatory Lead Oncology you will set...RegulatoryMinimum wageTemporary workLocal areaRemote workWorldwide- A global pharmaceutical company is seeking an Associate Director for Global Regulatory Affairs. This role involves acting as a Subject Matter Expert and managing all assigned programs while ensuring compliance with advertising and promotion regulations. Candidates should...RegulatoryRemote work
$154.4k - $242.55k
...company to inspire you and empower you to shine? Join us as Global Biomarker Lead, Inflammation, GI2 TAU based in Cambridge, MA reporting to... ...nomination documents, clinical protocols and documents submitted to Regulatory Agencies.• Establish and maintain scientific dialogue with...RegulatoryMinimum wageTemporary workLocal area- Celea Therapeutics is seeking a highly motivated Clinical Trial Site Activation Lead to drive late-stage site activation globally. You will manage feasibility, regulatory submissions, and site readiness, coordinating sponsors, CROs, and legal teams to accelerate timelines...RegulatoryRemote job
$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... ...all submissions conform to health authority guidelines Lead Regulatory CMC discussions and interactions with health authorities...RegulatoryPermanent employmentWork at officeWork from home- Moderna is seeking an Associate Director, Global Regulatory Advertising and Promotion to ensure compliance for promotional materials across channels. You will liaise with Regulatory Affairs, Legal, Medical, and Commercial teams to guide advertising and promotional activities...Regulatory
$144.5k - $195.5k
The Global Study Lead (Sr. Manager, Clinical Operations) is responsible for leading the operational planning and execution of global clinical... ...Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs; which may include acting...RegulatoryFull timeTemporary workLocal areaRemote workFlexible hours
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