CMC Regulatory Leader for Biologics & ATMPs
Biogen, Inc.
Biogen seeks a Head of Regulatory CMC - Biologics & Advanced Therapy Medicinal Products to lead the regulatory strategy across biologics and ATMPs. Based in Cambridge, MA, you will align regulatory science with development, manufacturing, and governance, driving timely approvals and lifecycle management. You will manage a global team, influence external Health Authorities, and partner with Operations, Quality, and Supply Chain to deliver on portfolio objectives. #J-18808-Ljbffr Biogen, Inc.
- Biogen in Cambridge, MA is seeking a Head of Regulatory CMC for Biologics & ATMPs. This hybrid role leads a global CMC regulatory strategy, aligning... ...Technical Operations, Quality, and Supply Chain. A senior leader with depth in regulatory sciences and biologics/ATMPs is...Regulatory
$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... ...business timelines.Who You Are:You are a visionary leader with a deep understanding of regulatory sciences...RegulatoryFull timeTemporary workLocal area$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$148.5k - $214.5k
Job title: CMC dossier leaderLocation: Framingham, MAAbout the jobAre you ready to shape... ...CMC dossier Sciences team as CMC dossier leader and you’ll contribute to the CMC... ...leading the preparation of CMC dossiers for regulatory submissions to enable advancement of company...RegulatoryFull time- Moderna is seeking an Associate Director, Global Regulatory, CMC to coordinate regulatory CMC activities across product lifecycles and develop... ...approvals. The role requires 8+ years in pharma/biotech with biologics CMC regulatory experience, strong CTD knowledge, and...Regulatory
$238k - $374k
...will have a dedicated group of experienced biologic drug hunters with the autonomy of a... ...candidates based on scientific, clinical, CMC, and commercial considerations; balance potency... ...; strong business acumen including regulatory (BLA/MAA pathway) and commercial awarenessAdditional...RegulatoryMinimum wageTemporary workLocal areaRemote work$163.5k - $281.6k
...and strategic Director/Senior Director, Regulatory CMC to lead and execute regulatory CMC strategies... ...therapeutic medicinal products (ATMPs).Lead and mentor junior regulatory CMC professionals... ...(e.g., Biochemistry, Molecular Biology, Chemistry, Pharmacy, Chemical Engineering...RegulatoryFor contractorsWork at officeFlexible hours$136.51k - $204.77k
...Job Title: Associate Director, CMC Lead Introduction to... ...IND/IMPD Readiness: Lead CMC regulatory strategy; guide and contribute... ...sections for IND/IMPD filings for biologics, conjugates, or complex... ...scientists, clinicians, and CMC leaders who challenge assumptions and...RegulatoryHourly payTemporary work- 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
- Moderna seeks an Associate Director, Global Regulatory-CMC in Norwood, Massachusetts. This role involves coordinating regulatory CMC activities... ...have at least 8 years in the biotech space, particularly in biologics-focused regulatory CMC. The position offers a competitive...Regulatory
$148.5k - $214.5k
Sanofi is seeking a CMC dossier leader to manage the preparation and development processes within the CMC Dossier Sciences team. This role... ...focuses on leading cross-functional teams and ensuring timely regulatory submissions while leveraging digital tools and AI solutions....Regulatory- ...options plan Scientist/Senior Scientist, Biology Lead – Kidney Experience About the... ...· Serve as a scientific leader across biology, platform, and therapeutic... ...with chemistry, delivery, translational, regulatory, and external teams · Help define...Regulatory
- ...seeks an Executive Director or VP of CMC to drive portfolio-level CMC strategy... ...multiple emerging modalities. This senior leader will shape long-range CMC strategy,... ...experience in both small molecules and biologics with regulatory and portfolio management expertise. #J...Regulatory
$170.9k - $231.3k
Overview The Associate Director, Regulatory Affairs CMC Development is responsible for developing and... ...a broad scientific foundation in biologics and/or complex modalities, along with... ...Careers website: About AlnylamWe are the leader in RNAi therapeutics - a revolutionary...RegulatoryFull timeTemporary workWork at officeLocal areaFlexible hours$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... ...:BS/MS, Ph.D., in Biology, Chemistry, Chemical Engineering...RegulatoryFull time$190.4k - $285.6k
...Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible for developing... ...skills.Ability to influence senior leaders and governance committees.Strong organizational... ...:Bachelor’s Degree in Chemistry, Biology, Pharmacy, Regulatory Affairs,...RegulatoryFull timeSummer workRemote workFlexible hours2 days per week$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... .... Globally influence and serve as a key opinion leader and resource within Takeda and externally with stakeholders...RegulatoryMinimum wageFull timeTemporary workLocal areaWorldwideNight shift- ...analytical method development for critical quality attributes in biologics. You will guide LC/MS workflows, peptide and disulfide mapping... ...characterization, strong communication, and ability to drive regulatory submissions across cross-functional teams. #J-18808-Ljbffr...Regulatory
$204k - $245k
...Director, Regulatory CMC Somerville, MA At Genetix Biotherapeutics every role has meaning, every team member is respected, and every... ...Master's degree in life sciences (biochemistry, chemistry, biology, biochemical engineering, or related field) Minimum of 10–...RegulatoryFull timeWork at officeFlexible hours3 days per week$150k - $211k
...further establish ourselves as leaders and innovators in Oncology.... ...Director of Drug Substance (Biologics), MSAT, this role is an individual... ...cycle management, and global regulatory submissions of complex... ...various SMEs from MSAT, QA, QC, CMC, External Manufacturing, internal...RegulatoryTemporary workRemote workWorldwideFlexible hours$238k - $374k
...DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you looking for a... ...and submissions for small molecule and biologic products through Phase 2 development.... ...execution.• Serves as an influential leader internally and externally, shaping early...RegulatoryMinimum wageTemporary workLocal areaRemote work$130.8k - $209.4k
...scientific and operational stability leader to support stability strategy... ...-life recommendations, and regulatory support for assigned... ...Collaborate across cross-functional CMC teams to align study... ...supporting stability programs for biologics, vaccines, or other complex drug...RegulatoryPermanent employmentWork at officeWork from home- ...enable innovation in drug development, biologics, and advanced therapies.About HEDWe are... ...evolving industry. The Life Science Sector Leader is responsible for driving the strategic... ...projects.Monitor industry trends and regulatory changes to ensure compliance and innovation...Regulatory
$181k - $208k
...Us: Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin... ...positive company culture. Job Title: Associate Director, Regulatory CMC (Biologics) Location: Hybrid – Waltham, MA ....RegulatoryFull time- ...Associate Director, Regulatory Affairs CMC Founded over a decade ago, CRISPR Therapeutics is a... ...research-stage organization into an industry leader, marking a historic milestone with the... ...required in biochemistry, chemistry, biology, or related pharmaceutical fields...RegulatoryContract workRemote work
$148.5k - $214.5k
Job Title: MSAT Industrialization Leader, Drug Product SyntheticsLocation: Cambridge, MAAbout... ...of Manufacturing & Supply (M&S) within CMC projects from Phase 2 Development to TT... ...other related fields.7+ years of experience Regulatory CMC, Process / Pharmaceutical...RegulatoryFull timeContract workWorldwide- ...Vice President of Regulatory Affairs, Founding Regulatory Leader, Ophthalmology & Retina About the Company Well-funded clinical-stage biotech in ophthalmology... ...a strategic thinker, capable of influencing clinical, CMC, and organizational direction, and be comfortable in a...Regulatory
- ...Therapeutics in Cambridge, MA is seeking an Associate Director of Regulatory Data Management & Intelligence to define data strategy,... ...Tableau. Collaboration across Regulatory Affairs, Operations, CMC, and Digital is essential. #J-18808-Ljbffr Moderna TherapeuticsRegulatory
- ...Associate Director, Cell Therapy CMC & Manufacturing We are... ...highly experienced and visionary leader of CMC & Manufacturing to lead... ...transfer. Contribute to regulatory filings (CMC sections of IND/CTA... ...PhD (preferred) or MS in Cell Biology, Immunology, Bioengineering, or...Regulatory
$212k - $333.19k
...us as a Senior Director, Global Program Leader - Oncology, Solid Tumors in our Cambridge... ...leadersCommitted to simultaneously driving regulatory approval as well as launch and global... ...Commercial Subteam, Pharmaceutical Sciences (CMC) Subteam, etc. to the GPT through...RegulatoryMinimum wageTemporary workWork at officeLocal areaRemote workNight shift
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