Biologics CMC Regulatory Lead — Associate Director
Planet Pharma
Planet Pharma is seeking a Senior Manager, CMC Regulatory Affairs in San Diego to lead global regulatory strategies for biologics development and lifecycle management. You will guide regulatory submissions and coordinate with cross-functional teams to align with regulatory requirements.
Ideal candidates have 7+ years in regulatory affairs with CMC for biologics, experience with global submissions, and a track record in Phase 3 programs and complex biologics.
#J-18808-Ljbffr$150k - $195k
...to pursue our vision of becoming a leading biopharmaceutical company dedicated... ...rare patients.Position Summary:The Associate Director, CMC Regulatory Affairs is responsible for providing... ...lifecycle management activities for biologic products, with a strong focus on late...SuggestedFull timeTemporary workRemote work$132k - $172k
...Position Summary The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic... ...and commercial programs. This role leads the development and execution of global... ...and lifecycle management activities for biologic products, with a strong focus on late-stage...SuggestedRemote workWorldwide$132k - $172k
...Senior Manager, CMC Regulatory Affairs (Small Molecules) Position Summary The Senior Manager... ...and commercial programs. This role leads the development and execution of global... ...lifecycle management. Experience supporting biologics or biotechnology products is considered...SuggestedRemote work- JOB SUMMARYThe Associate Director/Director of Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC) will lead global CMC regulatory strategy and execution across Iambic's development programs. The role will prepare and oversee high-quality CMC content for regulatory...SuggestedWork at officeFlexible hours
$227.42k - $275.58k
...expertise and resources of a leading innovator in oncology. Our... ...scientific leader to lead our biology organization. This... ...environment.Position Summary:The Director, Biology Group Lead will lead... ...Toxicology, Clinical Pharmacology, Regulatory, and CMC teams.Ensure biology data...SuggestedHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaImmediate startRemote workFlexible hours$150k - $195k
...staffingfuture.comPosition Summary:The Associate Director, Technical Operations, Biologics Drug Substance Manufacturing is... ...Operations, Quality, and Regulatory Affairs on manufacturing processes... ...technical documentation supporting CMC sections of IND, BLA, and regulatory...Contract work- ...Operations, Quality Assurance, Regulatory Affairs, Process Development... ...functions to ensure that all CMC deliverables are on track, technically... ...impact. Organize and lead internal project meetings, prepare... ...field (e.g., Chemistry, Biology, Immunology, Microbiology) and...Full timeContract workFlexible hours
$149.2k - $223.8k
...patients, their families, and society.Job SummaryThe Associate Director, Automation Scientist — Biology is a senior technical expert role within the Smart Research... ...development, automation, and functional expertise to lead assigned research programs, and workflow...$150k - $195k
...pursue our vision of becoming a leading biopharmaceutical company... ...patients.Position Summary:The Associate Director, Technical Operations (Small Molecule CMC) will provide technical oversight... ...partner closely with Quality, Regulatory Affairs, Clinical, and Supply Chain...Full timeContract workTemporary workRemote work$150k - $195k
...pursue our vision of becoming a leading biopharmaceutical company... ....Position Summary:The Associate Director, Technical Operations is responsible... ...analytical operations of a biologics product and serves as an... ...cGMP and international regulatory standards. The candidate must...Full timeTemporary workRemote work- ...and oversee method development, validation, and transfer for biologics products at CDMOs/CROs.Oversee specification setting of drug substance... ...act as the technical subject matter expert in preparation of regulatory submissions related to drug substance and drug product...
$155k - $190k
...can utilize in a community setting. Our lead product candidate, AlloNK®, is a non-genetically... ...: We are seeking an experienced CMC Project Management professional to lead the... ...could affect PPQ timing or downstream regulatory and clinical supply needs, and flag them...Flexible hours$170k - $275k
...are currently seeking a highly motivated, creative CMC formulation professional at associate director or director level to join our CMC team in San Diego.... ...in support of life cycle of quality improvement and regulatory filing/updates. Work closely with a cross-functional...- Job DescriptionOur Company is preparing for the potential US launch of an oncology mRNA-based individualized neoantigen therapy for early stage melanoma which involves operational complexities for treatment sites and requires close coordination with cross-functional partners...Full time
$150k - $170k
...addressable by small molecules and biologics. Arrowhead is leading the field in bringing the... ...in need. The PositionThe Associate Director, Global Strategic... ...ensure contracts reflect regulatory, compliance, and IP... ...partner to Global Operatoins, CMC and other leaders.Advise...Contract workWork at office- Job Description:We are seeking a Director, CMC-Drug Substance to join our growing organization... ...with corporate strategic goals, regulatory guidance documents regarding pharmaceutical... ...commercial supplyProvide deep expertise in biologics manufacturing platforms (e.g., CHO cell...Full timeContract workTemporary workLocal areaMonday to FridayFlexible hoursShift work
- ...Planet Pharma is seeking a Senior Manager, CMC Regulatory Affairs (Small Molecules) in the United States. The role drives global CMC regulatory... ...on oral solids and manufacturing processes. You will lead cross-functional teams, coordinate global submissions, and provide...
$150k - $170k
...addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of... ...patients in need. The PositionThe Associate Director, Operations Network and Strategy is... ...aspect of technical operations or CMC.Demonstrated ability to effectively...Work at office- ...Description Job Description Lead the global chemistry, manufacturing, and controls (CMC) strategy, process optimization... ...cGMP and phase-appropriate regulatory guidelines. Author, review,... ...collaborating closely with Discovery Biology, Translational Research,...Contract workLocal area
$205.1k - $307.7k
...offices.Key Responsibilities:Leading legal projects and... ...exhaustive, list of the usual duties associated with the position. Changes to... ...of genetics and other biological sciences is beneficial.All listed... ...salary range for the Associate Director, Legal (San Diego/Hybrid)...Full timeWork at officeLocal areaMonday to Friday2 days per week3 days per week$190.54k - $230.89k
...expertise and resources of a leading innovator in oncology. Our... ...RayzeBio: RayzeBio is seeking an Associate Director, In‑Vivo Pharmacology to... ...operations, animal welfare, and regulatory compliance (IACUC/AALAC).... ..., imaging, radiochemistry, biology and DMPK teams to align in‑vivo...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaImmediate startRemote workFlexible hours$172k - $258k
...seeking a dynamic and experienced Associate Director of Laboratory Engineering and Technology Site Lead West Coast (LE&W) to join our... ...operations align with regulatory standards while leveraging digital... ...scientific discipline (e.g., Biology, Chemistry,); Master’s degree...Full timeSummer workLocal areaRemote workFlexible hours2 days per week$201.59k - $244.28k
...changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers... ...medicinal chemist who is seeking to lead and contribute to the drug discovery portfolio... ...approaches, integrating structural biology, ADME, and computational insightsPartner...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$200k - $214k
...Therapeutics is seeking a highly motivated Associate Director, Immunology with demonstrated skills in... ..., auto-immunity, and/or immune cell biology. The incumbent will ideate, develop,... ...development and troubleshooting, as well as leading a small team of scientists in...Full timeSummer workRelocationFlexible hours- ...are seeking a strategic and experienced Associate Director of Immunology to help drive our efforts... ...individual will serve as an immunology lead and bring strong scientific expertise,... ...in Immunology, Microbiology, Molecular Biology, or a related field with 10 + years of...Summer holidayLocal area
$176.6k - $294.3k
...ROLE SUMMARY Discovery Network (DN), External Science Lead Biologics Discovery and Design supports Pfizer's broad strategic objectives... ...disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement...Permanent employmentFull timeH1bLocal areaVisa sponsorshipWork visaRelocation package2 days per week$173.22k - $209.9k
...expertise and resources of a leading innovator in oncology. Our... ...more about RayzeBio: The Associate Director of Clinical Science plays a... ...preparation/review of INDs, regulatory documents, IND annual report... ...experience OR BS in Biological Sciences, health care, or a...Hourly payFull timeContract workTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaImmediate startRemote workFlexible hours- ...Neomorph in San Diego seeks an Associate Director of Immunology to lead discovery programs in autoimmunity and inflammation, shaping strategic drug development... ...an ability to drive cross‑functional teams across chemistry, biology, and translational science. #J-18808-Ljbffr...
$175k - $185k
...can utilize in a community setting. Our lead product candidate, AlloNK, is a non-... ...SVP, Research & Early Development, the Associate Director, Biomarker Operations is responsible for... ...entities.Bachelor’s or Master's degree in biology, immunology, or related fields and/or...Contract workFlexible hours$185k - $205k
...are seeking an experienced, strategic Associate Director to lead Atrium's Translational Medicine... ...clinical study reports (CSRs), and other regulatory submission documents Lead the publication... ...: ~ PhD in Cardiovascular Biology, Molecular Biology, Physiology, or a...Summer holiday
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