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
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Global Biologics CMC Regulatory Lead in Boston, MA vacancy
- Biogen in Cambridge, MA is seeking a Head of Regulatory CMC for Biologics & ATMPs. This hybrid role leads a global CMC regulatory strategy, aligning development, manufacturing, and regulatory activities to ensure timely approvals and lifecycle progression. You will guide...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
- Takeda is seeking a senior Regulatory CMC lead in Boston, hybrid: you will own global CMC strategy and drive major submissions across development and lifecycle. You will collaborate with Regulatory, Development, and Commercial teams, negotiate with Health Authorities,...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
- Biogen seeks a Head of Regulatory CMC - Biologics & Advanced Therapy Medicinal Products to lead the regulatory strategy across biologics and ATMPs. Based in Cambridge,... ...approvals and lifecycle management. You will manage a global team, influence external Health Authorities,...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 is seeking an Associate Director, Global Regulatory-CMC to coordinate regulatory CMC activities across product lifecycles, develop global... ...agency correspondence and regulatory applications. The role leads interactions with health authorities, manages multiple...Regulatory
- Moderna is seeking an Associate Director, Global Regulatory, CMC to coordinate regulatory CMC activities across product lifecycles and develop... .... The role requires 8+ years in pharma/biotech with biologics CMC regulatory experience, strong CTD knowledge, and excellent...Regulatory
- Moderna is seeking an Associate Director, Global Regulatory, CMC to coordinate CMC regulatory activities across product lifecycles and to develop global strategies that align with business priorities. You will guide product teams, prepare CMC and Quality submissions, and...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
$166.4k - $249.6k
...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$241k - $332k
About This Role:As the Head of Regulatory CMC - Biologics & Advanced Therapy Medicinal Products (ATMP), you will lead a dynamic team within the PO&T function, driving the regulatory... ...Biogen’s portfolio. Your role encompasses global, regional, and local accountability for all...RegulatoryFull timeTemporary workLocal area$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
...knowledge.Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you looking for... ...submissions for small molecule and biologic products through Phase 2 development.... ..., EU, Japan, China).ACCOUNTABILITIES Leads and develops a team of regulatory...RegulatoryMinimum wageTemporary workLocal areaRemote work$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 wageTemporary workLocal areaRemote workWorldwide- ...Therapeutics, based in Boston, is seeking an Associate Director for Regulatory Affairs CMC to oversee regulatory strategies for innovative gene... ...extensive experience in CMC regulatory requirements for biologics and gene therapies. The ideal candidate will have over 1...RegulatoryRemote workFlexible hours
- 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
$196k - $269.5k
...realize our ambitions, the argenx Global Commercial Team is looking... ...Director, Global Indication Lead, Rheumatology.In this key... ...sciences or additional education in biology, chemistry, life sciences... ...understanding of the legal, regulatory and commercial environment across...RegulatoryFull timeTemporary workWork at officeRemote work$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$154.4k - $242.55k
...Translational Pharmaceutical Sciences and Precision MedicineThe Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies... ...is desired.Experience in plasma-derived therapies and biologics preferred.Bachelor’s or Master’s degree required....RegulatoryMinimum wageTemporary workLocal area$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- 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 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...Regulatory
$142.5k - $256.5k
The RoleThe Associate Director, Global Regulatory, CMC will be responsible for coordinating regulatory... ...Qualifications)BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical... ...in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure...RegulatoryPermanent employmentFull timeWork at officeWork from home$212k - $333.19k
...therapies to patients worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations Human Factors, you will... ...driving prospective and proactive implementation. Globally influence and serve as a key opinion leader and resource...RegulatoryMinimum wageFull timeTemporary workLocal areaWorldwideNight shift$208.2k - $327.14k
Global Therapeutic Research Lead - Immunology Job Description At Takeda, we are a forward‑looking, world‑... ...assets, must include experience with biologics and preferably across multiple... ...pharmaceutical industry, including regulatory requirements and commercial considerations...RegulatoryFull timeTemporary workFor contractorsLocal areaRemote workWorldwide$142.5k - $256.5k
Role Overview The Associate Director, Global Regulatory-CMC will coordinate regulatory CMC activities... ...with health authority guidelines. Lead regulatory CMC discussions and interactions... ...Qualifications BS, MS, or PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical...Regulatory$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
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Biologics CMC Regulatory Lead. Be the first to apply!
Related searches