Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Director Regulatory Site CMC (Hybrid) - Post-Approval

$174.5k - $274.23k

BioSpace

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

Vacancy posted 5 days ago
Similar jobs that could be interesting for youBased on the Director Regulatory Site CMC (Hybrid) - Post-Approval in Boston, MA vacancy
  • $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... 
    Website
    Minimum wage
    Full time
    Temporary work
    Local area
    Remote work
    Worldwide

    Initial Therapeutics, Inc.

    Boston, MA
    4 days ago
  •  ...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... 
    Website
    Contract work
    Remote work

    CRISPR Therapeutics

    Boston, MA
    3 days ago
  • 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

    Initial Therapeutics, Inc.

    Boston, MA
    4 days ago
  • $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... 
    Website
    Minimum wage
    Full time
    Local area
    Flexible hours

    Madrigalpharma

    Waltham, MA
    5 days ago
  • $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... 
    Suggested
    Full time
    Work at office
    Flexible hours
    3 days per week

    Genetix Biotherapeutics

    Somerville, MA
    5 days ago
  • $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.... 
    Website
    Full time
    Work at office
    Relocation
    Flexible hours

    Scorpion Therapeutics

    Cambridge, MA
    3 days ago
  • $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... 
    Website
    Permanent employment

    Initial Therapeutics, Inc.

    Norwood, MA
    2 days ago
  • $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 wage
    Full time
    Temporary work
    Work at office
    Local area
    Remote work
    Worldwide

    Initial Therapeutics, Inc.

    Boston, MA
    5 days ago
  • $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 wage
    Full time
    Temporary work
    Local area
    Remote work
    Worldwide

    Takeda Pharmaceutical Company Ltd

    Boston, MA
    6 days ago
  • $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. •... 
    Website
    Work at office
    Local area
    Remote work
    Worldwide
    Relocation package
    3 days per week

    Regeneron

    Cambridge, MA
    more than 2 months ago
  • $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... 
    Website
    Full time
    Temporary work
    Local area
    Flexible hours

    Alnylam Pharmaceuticals

    Cambridge, MA
    4 days ago
  • $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.... 
    Website
    Work at office
    Local area
    Relocation
    Flexible hours

    Akebia Therapeutics(R), Inc.

    Cambridge, MA
    4 days ago
  •  ...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-... 

    Vertex Pharmaceuticals

    Boston, MA
    15 hours ago
  • $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 wage
    Full time
    Temporary work
    Local area
    Remote work

    Takeda Pharmaceutical Company Ltd

    Boston, MA
    6 days ago
  • $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... 
    Website
    Remote work
    2 days per week

    Vertex Pharmaceuticals Inc (US)

    Boston, MA
    3 days ago
  •  ...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

    Scorpion Therapeutics

    Boston, MA
    4 days ago
  • $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 wage
    Full time
    Temporary work
    Local area
    Worldwide
    Night shift

    Takeda

    Boston, MA
    4 days ago
  • $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... 
    Website
    Full time
    Summer work
    Work at office
    Local area
    Remote work
    Flexible hours
    3 days per week

    Vertex Inc.

    Boston, MA
    17 hours ago
  • $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... 
    Website
    Full time
    Summer work
    Work at office
    Local area
    Remote work
    Flexible hours

    Vertex Inc.

    Boston, MA
    17 hours ago
  • ## 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... 
    Website
    Summer work
    Remote work
    Flexible hours
    2 days per week

    Vertex Pharmaceuticals

    Boston, MA
    3 days ago
  •  ...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... 

    Voyager Therapeutics, Inc.

    Cambridge, MA
    3 days ago
  • $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.... 
    Website
    Local area
    Relocation package

    Regeneron Pharmaceuticals

    Cambridge, MA
    2 days ago
  • $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 area
    Worldwide

    Dyne Tx

    Waltham, MA
    4 days ago
  • $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 time
    Flexible hours

    Madrigal

    Waltham, MA
    3 days ago
  • 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... 

    Vertex Pharmaceuticals Inc (US)

    Boston, MA
    5 days ago
  • $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... 

    JobRx, Inc.

    Boston, MA
    1 day ago
  •  ...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 office
    Local area
    3 days per week

    Bicara Therapeutics

    Boston, MA
    2 days ago
  • $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 time
    For contractors
    Local area
    Worldwide
    Relocation
    Visa sponsorship
    Flexible hours
    Shift work

    Merck & Co.

    Cambridge, MA
    9 days ago
  • **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... 
    Website
    Summer work
    Remote work
    Flexible hours
    2 days per week
    3 days per week

    Vertex Pharmaceuticals

    Boston, MA
    1 day ago
  • $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... 
    Website
    Local area
    Remote work
    Flexible hours
    2 days per week
    3 days per week

    Vertex Pharmaceuticals Inc (US)

    Boston, MA
    5 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Director Regulatory Site CMC (Hybrid) - Post-Approval. Be the first to apply!