Global Biologics CMC Regulatory Lead
Barrington James
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 requirements. This role requires a degree in a relevant field and 4+ years of experience in Regulatory Affairs CMC. Competitive compensation and opportunity for growth available. #J-18808-Ljbffr Barrington James
- ...Senior Manager/Associate Director for Global Regulatory Affairs CMC in Boston, MA. This key position... ...strategy and execution for innovative biologic therapies. The ideal candidate will have... ...complex regulatory frameworks. You will lead global regulatory submissions and...Regulatory
- Moderna seeks an Associate Director, Global Regulatory-CMC in Norwood, Massachusetts. This role involves coordinating regulatory CMC activities... ...at least 8 years in the biotech space, particularly in biologics-focused regulatory CMC. The position offers a competitive salary...Regulatory
$235k - $285k
Halozyme Hypercon in Boston is looking for a Senior Director, CMC Technical Lead to drive the development and implementation of scientific, technical, and regulatory strategies for biologics programs. This role will involve leading cross-functional teams, ensuring alignment...Regulatory- ...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- ...thing. Position Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for... ...compliance with FDA expectations and global standards. Prepare and review... ...communications. CMC experience for biologics, including regulatory...RegulatoryLocal area
- BioSpace is seeking an Associate Director, Global Regulatory-CMC in Norwood, Massachusetts. This role involves coordinating regulatory activities and developing CMC strategies for product lifecycles. Candidates should possess a PhD in a relevant field and a minimum of 8...Regulatory
- Takeda is seeking an Executive Director for Global Regulatory Affairs CMC Early Development in Boston, MA. This leadership position involves strategic... ...global CMC regulatory strategies for small molecules and biologics, from FIH to pre-pivotal development. Ideal candidates...Regulatory
$211.5k - $258.5k
Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading the... ...ensuring alignment with clinical, CMC, and non-clinical development activities... ...strategy development for biologics and/or small molecule therapeutics,...RegulatoryLocal areaFlexible hours2 days per week$238k - $374k
...patients worldwide. As Executive Director, Global Regulatory Affairs CMC Early Development you will provide... ...strategies for small molecule and biologic products for FIH to pre‑pivotal development... ..., China). How You Will Contribute Leads and develops a team of regulatory...RegulatoryFull timeTemporary workLocal areaWorldwide$178.5k - $257.83k
Job title: Global Regulatory Lead Location: Morristown, NJ / Cambridge, MA About the job As the Global Regulatory Lead on our Global Regulatory... .... Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) is preferred. At least 8‑...Regulatory- ...Vice President, Global Program Lead, Neurology About the Company Internationally renowned biopharmaceutical... ...expertise in drug development principles, regulatory expectations, and a strong background in basic biology, pharmaceutical optimization, translational medicine...Regulatory
$196k - $269.5k
## Director, Global Indication Lead, RheumatologyApplylocations: Boston, MA, USAtime type: Full timeposted... ...sciences or additional education in biology, chemistry, life sciences... ...preferred* Deep understanding of the legal, regulatory and commercial environment across major...RegulatoryTemporary work- Takeda in Boston, MA, seeks an experienced Regulatory CMC professional to lead submission planning and execution for clinical and post‑marketing programs. You will work with global teams to align regulatory strategy with product development goals. The role emphasizes regulatory...Regulatory
$212k - $333.19k
...patients worldwide. About the role As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations Human Factors, you... ...thereby driving prospective and proactive implementation. Globally influences and serves as a key opinion leader and...RegulatoryFull timeTemporary workLocal areaWorldwideNight shift- Takeda is seeking a Director Regulatory Site CMC in Boston, MA, to lead regulatory change management activities and ensure compliance with global HA requirements. The ideal candidate has over 10 years of biopharmaceutical/device industry experience and a strong understanding...Regulatory
$177k - $278.08k
...class and best‑in‑class therapies, including ADCs, complex biologics and small molecules. Our goal is to accelerate access to transformative... ...impact on patients worldwide. Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the global regulatory...RegulatoryMinimum wageFull timeTemporary workLocal areaWorldwide- Job Title: CMC Demand & Supply Leader Location: Framingham... ...CMC function, in the Global CMC Project Management... ...Projects in respect to Regulatory and Quality... ...Main Responsibilities Lead collaborative work with... ...Biochemistry, Molecular Biology, Biotechnology, Biomedical...Regulatory
$238k - $374k
...dedicated group of experienced biologic drug hunters with the... ...biotech and the resources of a leading pharmaceutical company. It is... ...based on scientific, clinical, CMC, and commercial considerations... ...strong business acumen including regulatory (BLA/MAA pathway) and...RegulatoryMinimum wageTemporary workLocal areaRemote work$204k - $292k
Repertoire-Immune-Medicines is seeking a Vice President, Head of CMC in Cambridge, MA. This role involves leading all CMC activities for protein biologics, establishing CMC strategy, and managing external partnerships. Candidates must have a PhD and 15+ years in biotechnology...$137k - $215.27k
...worldwide. About the role This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute... ...as follows: Role With some supervision, leads the execution of regulatory CMC investigational,...RegulatoryMinimum wageFull timeTemporary workLocal areaWorldwide- ...Takeda is looking for a Senior Director and Regulatory Platform Lead in Boston, MA, to lead the development of innovative regulatory strategies... ...responsible for guiding regulatory strategies, interfacing with global health authorities, and ensuring high-quality regulatory...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
JobRx, Inc. is seeking a Director Regulatory Site CMC in Boston, MA. This pivotal role ensures compliant... ..., including small molecules and biologics. The ideal candidate will have over a decade... ...industry experience and lead initiatives focused on enhancing regulatory...Regulatory$193k - $210k
A pharmaceutical firm in Cambridge, MA seeks a Senior Regulatory Affairs Manager to lead the development and execution of regulatory strategies throughout... ...ensuring alignment with clinical plans and incorporating global Health Authority feedback. This role offers a competitive...Regulatory- GlaxoSmithKline in Cambridge, Massachusetts is seeking a Regulatory Affairs Manager to lead the Chemistry, Manufacturing, and Controls (CMC) regulatory strategy for vaccines. This role requires expertise in FDA regulations, strong communication skills, and experience with...Regulatory
$154.4k - $242.55k
JobRx, Inc. is seeking a Global Brand Lead (Associate Director) to drive global commercial initiatives during pre-commercialization and early... ...while ensuring compliance with Medical, Legal, and Regulatory teams. Applicants should possess at least 8 years of pharma...Regulatory$208.2k - $327.14k
A leading global R&D organization is seeking a Senior Director, Global Regulatory Lead - Oncology. This role involves leading global regulatory strategy and engaging with cross-functional teams to ensure the success of innovative oncology therapies. The successful candidate...Regulatory$174.5k - $274.23k
A leading biotechnology company is seeking a Director, Global Regulatory Lead, GI & Inflammation. The role involves defining global regulatory strategies, leading teams, and ensuring compliance with FDA regulations. Candidates should have over 8 years of pharmaceutical...Regulatory$209.35k - $258.6k
Akebia Therapeutics is seeking a Director of Regulatory Labeling in Cambridge, MA. This key role involves leading global labeling strategies across product life cycles and ensuring compliance with regulatory standards. The ideal candidate will have 10+ years of pharmaceutical...Regulatory
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