Remote Senior Manager, CMC Regulatory Affairs (Biologics)
Travere Therapeutics
Scorpion Therapeutics seeks a Senior Manager, CMC Regulatory Affairs to lead regulatory strategy for biologic drug development and lifecycle management. You will drive global CMC submissions and health authority interactions, enabling late-stage programs and rare indications.
Based remotely with up to 10% travel, you will collaborate with manufacturing, process development, and quality to ensure compliant processes and successful filings across INDs, BLAs, and NDAs.
#J-18808-Ljbffr- ...what you will doCurrently seeking a Regulatory Affairs (RA) Manager with strong CMC pre and post approval experience... ...functions, GRDRA region functions and Senior Director or Reg CMC Lead, agree on... ...flexible working arrangements, remote work options, and tax assistance...Remote workSeniorHourly payWork at officeLocal areaRelocation packageFlexible hours
$222k - $303k
...Role:We’re looking for a Senior Director, Regulatory Affairs CMC - Gene Therapy to help us... ...registration and life cycle management.What You'll Do: In this... ...Japanese regulations for biologics, including gene therapy,... ...’ll Work This is a fully remote role. It can be performed...Remote workSeniorFull timeLocal areaFlexible hours- ...Eastridge Workforce Solutions is seeking a Senior Regulatory CMC Lead to provide strategic Regulatory CMC leadership for a global biologics program. This role will lead CMC... .... Local Boston candidates are preferred; remote East Coast candidates will also be considered...Remote workSeniorLocal area
- ...Scorpion Therapeutics seeks a Director of Biologics CMC Technical Writing to lead the creation... ..., and Controls documentation for regulatory submissions such as BLA. You will translate... ...teams through reviews and approvals while remote work with roughly 10% travel. This...Remote workSenior
- ...Senior Director, Biologics CMC (4 days onsite, 1 day remote) Position Summary Reporting to the Head of CMC, the Senior... ...development, quality, regulatory CMC, and external manufacturing... ...authoring technical documents, and managing external partners. Primary...Remote workSeniorFull time
- ...Role:We’re looking for a Senior Director, Regulatory Affairs CMC – Gene Therapy to help us... ...registration and life cycle management.What You'll Do: In this... ...Japanese regulations for biologics, including gene therapy,... ...’ll Work This is a fully remote role. It can be performed...Remote workSeniorFull timeLocal areaFlexible hours
- ...Travere Therapeutics in San Diego, CA is seeking a Director of Technical Operations (Biologics CMC Technical Writing) to lead CMC documentation for regulatory submissions. The role emphasizes drafting Module 3 sections, writing drug substance/product manufacturing content...Remote work
- ...Location: North Carolina/Remote If you are interested in... ...Director/Director/Sr. Director, Regulatory CMC reports to the Vice... ...CMC and is responsible for managing the Company’s Regulatory CMC... ...experience in MSAT for MAB biological products. ~ Strong technical...Remote workFull timeContract workVisa sponsorshipWork visa
$222k - $303k
...: We’re looking for a Senior Director, Regulatory Affairs CMC to help us expand what’s... ...opportunity to plan, execute, and manage regulatory submissions... ...regulations for drugs/biologics with the ability to... ...Work This is a fully remote role. It can be performed...Remote workSeniorFull timeLocal areaWorldwideFlexible hours- ...Therapeutics is seeking a Director, Technical Operations (Biologics CMC Technical Writing) to lead authoring of CTD Module 2 and Module 3 content for regulatory submissions, including BLA. This role partners with Regulatory Affairs, SME, Quality, Manufacturing, and external...Remote work
$150k - $210k
...our expertise in muscle biology and small molecule... ...position will contribute regulatory CMC experience to Edgewise... ...with Regulatory Affairs, CMC, and Quality to ensure... ...using regulatory document management systems and archival... ...working in a remote environment. ~ Able...Remote workSeniorFull timeFor contractors- ...Providing strategic and operational leadership, the full-time remote Senior Director, Regulatory CMC will manage Regulatory CMC activities for small molecule development programs, overseeing global regulatory strategies and submissions while collaborating with internal...Remote workSeniorFull time
$143.23k - $185.35k
...Kite and help create more tomorrows.Job DescriptionThe Senior Manager, Regulatory Affairs CMC supports and drives increasingly complex CMC regulatory... ...working policy, offering a balanced approach with two days of remote working and three days working onsiteResponsibilities...Remote workSeniorFull timeFor contractorsWork at officeLocal areaRelocationFlexible hoursShift work$143.23k - $185.35k
...balanced approach with two days of remote working and three days... ...support integrated global CMC regulatory strategies for both T-cell drug... ...development and lifecycle management of the T-cell control strategy... ....Significant Regulatory Affairs CMC experience in biotechnology...Remote workSeniorFull timeFor contractorsWork at officeLocal areaRelocationFlexible hours- The Senior Manager Global Regulatory Affairs CMC - Biological & Non-Biol. Products is responsible for:Partnering closely with CSL’s R&D, Manufacturing, Quality, Regulatory Affairs stakeholders to address regulatory strategy challenges and deliver innovative, timely regulatory...SeniorFull timeLocal areaFlexible hours
$133.5k - $213.6k
Job Description:The Senior Manager of CMC Regulatory Affairs will be responsible for creating CMC regulatory development plans and for successful execution... ....Diverse technology experience (small molecules, biologics, parenteral and oral dosage forms)Must have a minimum...SeniorFull timeTemporary workWork at officeLocal areaNight shiftWeekend workAfternoon shift3 days per week$133.2k - $172.37k
## Manager, Regulatory Affairs CMCApply: Onsite - Hybrid Eligible: United States -... ...Manager, Global Regulatory CMC will support Kite’s autologous... ...approach with two days of remote working and three days... ..., Chemistry, Biochemistry, Biology, Chemical Engineering, or related...Remote workFull timeWork at officeRelocationFlexible hours- ...that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of... ...bring new therapies to patients in need. The Position The Sr Manager Regulatory CMC ensures efficient and compliant management of regulatory change...Senior
$108k - $176k
Manager, CMC Regulatory Affairs - BiologicsAt Regeneron, we use science and innovation to develop life-changing medicines for people with serious... ...diseases. We are seeking a Manager, CMC Regulatory Affairs - Biologics to join our CMC Regulatory Affairs team, supporting our...Full timeWorldwide$160k - $190k
...Fate Therapeutics is looking for Senior Manager, Regulatory Affairs CMC to help advance innovative cell therapy products from early development through... ...compliance. Qualifications Bachelor’s degree in biological, pharmaceutical, chemical, or engineering sciences...SeniorFull time$166.4k - $249.6k
...Manufacturing Controls (CMC) Associate... ...and executes global regulatory CMC strategies across... ...focusing on biologics. This role is accountable... ..., and lifecycle management of CMC sections of... ..., Regulatory Affairs, or related life science... ...: 1. Hybrid: work remotely up to two days per...Remote workFull timeSummer workFlexible hours2 days per week$230k - $270k
...autoimmune disease. Led by a management team with significant... ...seeking a highly motivated Senior Director, CMC Regulatory Affairs in the Global Regulatory... ...San Francisco and may be remote up to 2 days per week.... ...Practices (GMP), drug and biologics development regulations and...Remote workSeniorFull timeContract workInternshipLocal area2 days per week- ...Regeneron seeks a Manager of CMC Regulatory Affairs for biologics to lead regulatory strategy and compliance activities across product development, submissions, and post-market programs. The role involves collaborating with regulatory and CMC teams to ensure compliance...Worldwide
- ...Seeking a full-time Senior Manager Regulatory Affairs in Advertising & Promotion, this remote position will manage regulatory activities related to the advertising and... ...Experience with pharmaceutical products; biologics experience is a plus Ability to interact with...Remote workSeniorFull time
$160k - $274k
...biotechnology company is seeking a Senior Director, Mid-Atlantic CMC, to provide technical and portfolio leadership in a remote capacity. The ideal... ...must have strong project management skills and the ability to... ...range of $160,000 - $274,000. J-18808-Ljbffr WuXi Biologics GroupRemote jobSenior- ...implement comprehensive regulatory strategies for new... ...productlife cycle management, and post-market... ...junior regulatory affairs professionals,... ...Engineering, Chemistry, Biology) required.... ...in a leadership or senior role.Demonstrated... ...work-life balance. Remote or field-based positions...Remote workSeniorFull timeWork at office
- ...Travere Therapeutics seeks a Senior Project Manager in Technical Operations to drive CMC strategy for biologics programs, ensuring alignment with product development, clinical... .... You will partner across Quality, Regulatory, Supply Chain, and Clinical Supply to reach...Remote workSenior
$210k - $320k
...serious diseases.Position Overview: The Regulatory Director/Sr. Director Regulatory CMC will be responsible for preparing... ...(IND/CTA/MF and BLA/MAA).Plan and manage activities for the preparation of... ....Diverse experience including biologics in the cell therapy space, drugs,...SeniorFull timeShift work3 days per week1 day per week- ...in Shaping the Future of Regulatory Services. knoell is one of... ...seeking an experienced Senior Manager of Regulatory Affairs to join our North American... ...Bachelor’s degree required in Biology, Chemistry, Toxicology,... ...working policy and is a remote-first company, where you...Remote workSeniorPart timeWork at officeLocal areaWork from homeFlexible hoursShift work
- ...Shionogi is seeking a Senior Manager, Regulatory Affairs, Chemistry, Manufacturing, and Controls in Florham Park, NJ. The hybrid role blends strategic regulatory leadership with hands-on CMC submissions and compliance activities. You will coordinate cross-functional teams...Senior
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