Associate Director, Regulatory CMC - US (Remote)
Praxis Precision Medicines, Inc.
Praxis Precision Medicines, Inc. is seeking an Associate Director, Regulatory CMC to lead planning, preparation, and execution of regulatory activities for small molecule and ASO programs. You will coordinate with cross-functional teams and external vendors to support global submissions.
The role demands hands-on CMC regulatory expertise, ownership mindset, and strong collaboration to ensure regulatory-compliant, high-quality outcomes in a fast-paced biotech environment.
#J-18808-Ljbffr$154.4k - $242.55k
....This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will... ...to line management. More about us:At Takeda, we are transforming... ..." following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA1...Remote workMinimum wageLocal areaWorldwide$150k - $210k
...Position: This position will contribute regulatory CMC experience to Edgewise cardiovascular... ...regulatory submission activities for US and global assigned products. The submissions... ...-starter with experience working in a remote environment. ~ Able to adapt to...Remote workFull timeFor contractors$188k - $215k
...someone who defies convention, join us and work alongside some of the most respected... .... What You'll Do Senior Manager / Associate Director, CMC Regulatory Sciences reports to the head of CMC... ...2-3x per week. A US-based fully remote role may be considered for the right...Remote workWork at officeLocal areaFlexible hours$177k - $221k
...organization, we seek a strategic and hands-on Associate Director, CMC Regulatory who will be responsible for executing... ...(IND, IMPD/CTA, NDA, MAA, etc.) (US, EU, APAC, LATAM). Solid... ...across departments. #LI-CT1 #LI-Remote The base pay salary range for this...Remote workFull timeWork experience placementLocal areaWorldwide$139.8k - $209.7k
Associate Director, US Regulatory CMC At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer...SuggestedWork at officeLocal area2 days per week3 days per week- ...General Information Name: Associate Director, Regulatory Affairs - CMC Ref #: 15322 Posting Date: Tuesday, July 28... ...4-08-2026 Work Schedule: Full time Remote Work: In office Job: RI - R&D, Innovation... ...of radiopharmaceuticals in the US and in EU. This global role will...Remote workPermanent employmentFull timeTemporary workWork at office
$181.16k - $224.72k
Associate Director, CMC Regulatory Affairs Job Category : Development - Ionis Requisition Number : IONIS00415... ...energy into making our onsite, hybrid and remote work environments a place where solid... ...greatest achievements are ahead of us. If you’re passionate about the...Remote workFull time- ## Associate Director, Regulatory Affairs CMCApplyremote type: Site Basedlocations: South... ...patients. As the Regulatory CMC lead for these programs, you... ...for submission to US and ex-US regulatory agencies... ...dynamic workplace that balances remote work flexibility with the benefits...Remote workContract work
$145.6k - $279.4k
Associate Director, Regulatory Affairs - Biosimilars (US) Sandoz continues to go through an exciting and transformative period... ...to 50% of their monthly workday remotely. This role will not have the... ...partnership with Clinical, Nonclinical, CMC, Analytical Development, Quality,...Remote workWork at officeRelocation packageFlexible hours- ...Ionis Pharmaceuticals, Inc. in Carlsbad, CA, is seeking an Associate Director of CMC Regulatory Affairs to establish and execute global CMC regulatory strategies for commercial compounds. The role collaborates with cross-functional teams, partners, and vendors to deliver...Remote work
- Role: Associate Director, CMC Regulatory Affairs, providing strategic and operational leadership for regulatory activities related to small molecule... ...with major international regulatory agencies. Work Setup remote with some travel (~10%), onsite presence required in San...Remote work
$142.5k - $256.5k
The RoleModerna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal role will focus on preparing and overseeing... ...in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity...Permanent employmentFull timeWork at officeWork from home$166.4k - $249.6k
...DescriptionGeneral Summary:The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and... ...can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select2. On-Site: work...Remote workFull timeSummer workFlexible hours2 days per week$143k - $233k
...team, this position will play a key role in regulatory strategy development and execution of... ...assigned Chemistry, Manufacturing and Control (CMC) programs. Your Role: With minimal... ...drug discovery and passionate about making a difference in the lives of patients, join us!- JOB SUMMARYThe Associate Director/Director of Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC) will lead global CMC regulatory strategy and execution across Iambic's... ...partners, and will support interactions with the US FDA and other global health authorities as...Work at officeFlexible hours
$145.6k - $279.4k
...Job Description Summary The Associate Director, Regulatory Affairs – Biosimilars (US) leads U.S. regulatory strategy and... ...0% of the monthly workday can be remote). The role is not eligible for remote... ...with Clinical, Nonclinical, CMC, Analytical Development, Quality,...Work at officeVisa sponsorshipWork visaRelocation package- ...Padagis US LLC is seeking an experienced and dynamic Director or Associate Director of Regulatory Affairs that will be responsible for overseeing... ...entry. Note: This is a remote workplace eligible position... ...preclinical, clinical, and CMC submissions. Exceptional...Remote work
$142.5k - $256.5k
The Role Moderna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal role will focus on preparing and overseeing... ...in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an...Permanent employmentWork at officeLocal areaWork from home$141.5k - $268.5k
...Associate Director, Regulatory Affairs US Advertising and Promotion - Immunology Full-time Salary Min: 141500 Therapy Area: Immunology Salary... ...work a hybrid work schedule (3 days in office, 2 days remotely) from our Mettawa, IL; Florham Park, NJ or Irvine, CA...Remote workFull timeWork at officeLocal area$222k - $303k
...progress. That commitment has earned us recognition as Science magazine’s No.... ...the Role:We’re looking for a Senior Director, Regulatory Affairs CMC - Gene Therapy to help us expand what... ...desired.Where You’ll Work This is a fully remote role. It can be performed effectively...Remote workFull timeLocal areaFlexible hours$246.98k - $299.29k
...aren’t words that are usually associated with a job. But working at... ....bms.com/working-with-us.The GRS-CMC Director is responsible for overseeing... ...direction based on global regulatory guidelines and experience.... ...capability centers. Employees in remote-by-design or lab-based...Remote workHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work- ...Associate Director, Regulatory Affairs US Advertising and Promotion - ImmunologyAbbVie's mission is to discover and deliver innovative medicines and... ...work a hybrid work schedule (3 days in office, 2 days remotely) from our Mettawa, IL; Florham Park, NJ or Irvine, CA...Remote workWork at office
- ...progress. That commitment has earned us recognition as Science magazine’s No.... ...the Role:We’re looking for a Senior Director, Regulatory Affairs CMC – Gene Therapy to help us expand what... ...desired.Where You’ll Work This is a fully remote role. It can be performed effectively...Remote workFull timeLocal areaFlexible hours
$180k - $241k
...Description Primary Function: The Associate Director, Regulatory Affairs supports the... ...Regulatory Affairs and is based remote. Major Responsibilities and... ..., Medical Writing, CMC, and other functions. Partner... ...Notice available upon request. #J-18808-Ljbffr Zai Lab (US) LLCRemote workWorldwideRelocation package$140k - $200k
Overview The Senior Manager/Associate Director, Regulatory Affairs CMC is a strategic and hands on regulatory contributor responsible for defining and executing... .... Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence...Full timeWork at officeLocal area$162.5k - $227.5k
...coordinate, and drive cross-functional CMC activities supporting early-... ...Development, Quality, Regulatory, and Supply Chain to ensure successful... ..., strategic alliances, and remote or global teams is... ...Biotechnology and do not obligate us to pay fees should we hire from...Remote workFull timeWork at officeWork visa3 days per week- ...application process. Associate Director, Manufacturing... ...Full Time Malvern, PA, US 30+ days ago Requisition... ...Manufacturing, and Controls (CMC) project management... ...Development, Quality, Regulatory Affairs, Clinical... ...time in the office, and remote employees are expected...Remote workFull timeContract workWork at officeLocal area
$177k - $278.08k
...therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management... ...global HA requirements, beyond EU/US. who has an understanding of scientific... ...hybrid" following Takeda's Hybrid and Remote Work policy. #LI-Hybrid #LI-AA1 Takeda...Remote workMinimum wageFull timeLocal areaWorldwide$150k - $195k
...patients.Position Summary:The Associate Director, Technical Operations (Small Molecule CMC) will provide technical... ...closely with Quality, Regulatory Affairs, Clinical, and... ...-to-date knowledge of US and EU GMP requirements... ...is expected to be 100% remote.Travere is an EEO/AA/...Remote workFull timeContract workTemporary work$222k - $303k
...progress. That commitment has earned us recognition as Science magazine’s No... ...Role: We’re looking for a Senior Director, Regulatory Affairs CMC to help us expand what’s possible for... ...Where You’ll Work This is a fully remote role. It can be performed effectively...Remote workFull timeLocal areaWorldwideFlexible hours
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