Director Regulatory Site CMC (Hybrid) - Post-Approval
$174.5k - $274.23kBioSpace
A leading biopharmaceutical company is seeking a Director Regulatory Site CMC in Boston, MA. The role focuses on regulatory change control and post-approval activities, ensuring compliance across diverse modalities. Candidates should have over 10 years of experience in the biopharmaceutical industry, with a strong background in global HA requirements and regulatory strategy. This hybrid position offers a competitive salary range between $174,500 and $274,230 alongside comprehensive benefits. #J-18808-Ljbffr BioSpace
$177k - $278.08k
...therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant... ...management of regulatory change control and post‑approval activities at the site level.... ...position is currently classified as "hybrid" following Takeda's Hybrid and Remote...WebsiteMinimum wageFull timeTemporary workLocal areaRemote workWorldwide- ...historic milestone with the approval of CASGEVY® (... ...Reporting to the Head of Regulatory Affairs, you will work... ...patients. As the Regulatory CMC lead for these programs... ...: ~ Associate Director: ~12+ Years of relevant... ...at least three days on-site, creating a collaborative...WebsiteContract workRemote work
- Takeda is seeking a Director Regulatory Site CMC in Boston, MA, to lead regulatory change management activities and ensure compliance with global... ...encourages the use of automation to enhance efficiency. A hybrid work model is offered, complementing a robust compensation...Website
$207k - $253k
## Director, Regulatory Affairs CMCApplylocations: MA - Waltham -... ...: Full timeposted on: Posted 3 Days Agojob requisition... ...and only medication approved by both the FDA and... ...operational regulatory CMC leadership to support... ...our Madrigal Careers site. *Please be aware that...WebsiteMinimum wageFull timeLocal areaFlexible hours$204k - $245k
...with radical care. The Director, Regulatory CMC is responsible for leading... ...CMC regulatory strategies for approved and late-stage gene therapy... ...development and delivery of post-approval regulatory strategies... .... This is a full-time hybrid position (3 days a week) in...SuggestedFull timeWork at officeFlexible hours3 days per week$139.67k - $172.54k
Manager Regulatory Affairs, CMC Location: Cambridge, MA (later Waltham, MA) Job... ...while supporting hybrid flexibility based on role and... ...position reports to the Sr. Director, Regulatory Affairs CMC. Essential... ...Building Implement review, approval, and submission processes....WebsiteFull timeWork at officeRelocationFlexible hours$224.9k - $404.6k
...position will be based at Norwood, MA site and will be responsible for managing a team of CMC experts that prepare and oversee... ...agency correspondence and regulatory applications. This position will... ...authorities to facilitate review and approval of submissions at the expert...WebsitePermanent employment$238k - $374k
...worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination... ...and minimizing time to approval/clearance. Establish best... ...evidence, labeling/UDI, post‑market signals).... ...currently classified as "hybrid" following Takeda's Hybrid...Minimum wageFull timeTemporary workWork at officeLocal areaRemote workWorldwide$154.4k - $242.55k
...This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ..., registration and/or post-approval strategies for assigned products... ...position is currently classified as "hybrid" following Takeda's Hybrid and...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide$157.2k - $256.6k
...As an Associate Director you will lead the development and execution of global CMC regulatory strategies for the hematology and oncology... ...,, NY this role is on-site 4 days in the office and 1 day... ...initial market applications, and approval/post-approval activities. •...WebsiteWork at officeLocal areaRemote workWorldwideRelocation package3 days per week$144.4k - $195.4k
Overview The Senior Manager, Regulatory Affairs CMC Development is responsible... ...position reports to the Director of Regulatory Affairs CMC,... ...equivalent. This position is hybrid and will be primarily located... ...this role at the time of posting. Base pay will be determined...WebsiteFull timeTemporary workLocal areaFlexible hours$209.35k - $258.6k
...engagement while supporting hybrid flexibility based on... ...you? Job Summary The Director, Regulatory Affairs - Labeling is... ...development through post-marketing optimization... ..., Legal, Safety, and CMC. Facilitate alignment... ...development, review, approval, and implementation....WebsiteWork at officeLocal areaRelocationFlexible hours- ...Pharmaceuticals in Boston seeks a Director, Global Submission Management to lead global regulatory submissions across development... ...and coordinating with Strategy, CMC, Labeling, Publishing, and Advertising... ...Smartsheet, and Veeva RIM in a hybrid work environment. #J-18808-...
$238k - $374k
...best of my knowledge. Job Description Executive Director, Global Regulatory Affairs CMC Early Development Are you looking for a patient-... ...strategies. This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work...Minimum wageFull timeTemporary workLocal areaRemote work$192k - $288k
Overview The Director, Regulatory Data is responsible for leading the strategy, governance,... ...maintenance, and reporting based on approved sources of truth. Accountable for... ...bonus and equity awards. Flexibility Hybrid‑Eligible or On‑Site Eligible: Choose up to two remote...WebsiteRemote work2 days per week- ...development and implementation of regulatory strategies for pure device and... .... Maintain and communicate CMC/quality guidance and... ...global health authorities. Review/approve device design control and Human... .../NDA/510(k), technical files, post-approval submissions); strong...Night shift
$212k - $333.19k
...to patients worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations... ...global health authorities. Review and approve medical device development design... ...Technical File submissions, global post‑approval submissions, etc.) is...Minimum wageFull timeTemporary workLocal areaWorldwideNight shift$196.8k - $295.2k
...General Summary: The Regulatory Strategy Director will be responsible... ...strategy. This is a hybrid position requiring 3... ...from first-in-human to post marketing application... ...-Eligible Or On-Site Eligible Flex Eligibility... .... The company has approved medicines that treat...WebsiteFull timeSummer workWork at officeLocal areaRemote workFlexible hours3 days per week$232k - $348k
Job Description The Regulatory Strategy Senior Director is a regulatory leader... ...strategy. This is a hybrid position requiring 3... ...first-in-human to post marketing application... ...-Eligible Or On-Site Eligible Flex Eligibility... .... The company has approved medicines that treat...WebsiteFull timeSummer workWork at officeLocal areaRemote workFlexible hours- ## Director, Regulatory Data Management (Boston, MA)Applylocations: Boston... ...: Full timeposted on: Posted Yesterdayjob requisition... ...regulatory information based on approved sources of truth.*... ...more.**Flex Designation:**Hybrid-Eligible Or On-Site Eligible**Flex Eligibility...WebsiteSummer workRemote workFlexible hours2 days per week
- ...The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising... ...and late stage programs to secure approval of the manufacturing process and... ...INDs, CTAs, BLAs and MAAs including post-approval supplemental applications and...
$205k - $341.6k
...The Director Regulatory Affairs will provide leadership on global regulatory... ...submissions required for regulatory approval. Work with project teams... ...required to be performed on-site. Please speak with your... ...For jobs in Canada: this posting is for an existing position....WebsiteLocal areaRelocation package$196k - $240k
...and Facebook . Role Summary The Director, Regulatory Affairs – Chemistry, Manufacturing, and Controls (CMC) is responsible for defining... ...development, through and beyond product approval. This role plays a critical... ...IND, IMPD, BLA/MAA, and post-approval lifecycle management...Local areaWorldwide$207k - $253k
...associated steatohepatitis (MASH). This role provides strategic, tactical and operational regulatory CMC leadership to support clinical trial applications, market registrations and post‑approval submissions, and manages day‑to‑day regulatory CMC activities for assigned...Full timeFlexible hours- Vertex Pharmaceuticals Inc (US) is seeking a Regulatory Strategy Senior Director to lead the development of regulatory strategies for complex projects... ...leadership in a matrix environment. Vertex offers a hybrid work arrangement and competitive benefits. #J-18808-Ljbffr...
$177k - $278.08k
JobRx, Inc. is seeking a Regulatory Affairs professional in Boston, MA to manage regulatory CMC strategy for pharmaceutical products. The role requires 10+ years of experience... ...regulatory compliance. This position offers a hybrid work model and a competitive salary ranging from...- ...strategic and experienced Senior Director of Regulatory Affairs to lead and execute... ...through BLA submission and approval. You will manage a small... ...Boston office and follows a hybrid schedule, with three in-office... ...(Clinical, Nonclinical, CMC, Biostatistics, Clinical Operations...Work at officeLocal area3 days per week
$190.8k - $300.3k
...Description Principal Scientist / Director, GLOBAL REGULATORY CMC Biologics (R5) Under general... ...CMC guidelines regarding IND/BLAs or post approval changes. The CMC Project Lead is... ...0% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid...Full timeFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work- **Job Description**The Director, Global Regulatory Affairs Process Excellence & Transformation... .... This is a Boston based, hybrid position requiring 3 days/... ...this job at the time of posting. This role is eligible for... ...:**Hybrid-Eligible Or On-Site Eligible**Flex Eligibility...WebsiteSummer workRemote workFlexible hours2 days per week3 days per week
$232k - $348k
Regulatory Strategy Senior Director The Senior Director of Regulatory Strategy leads the development... ...role is based in Boston, hybrid (3 days onsite per week),... ...(from first‑in‑human to post‑marketing application stage... ...per week, or select On‑Site: work five days per week on...WebsiteLocal areaRemote workFlexible hours2 days per week3 days per week
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