Associate Director, Regulatory Affairs CMC - Submissions
Crinetics Pharmaceuticals
Crinetics Pharmaceuticals in San Diego is seeking an Associate Director, Regulatory Affairs CMC to support regulatory strategy implementation for development programs. This role requires overseeing regulatory submissions and ensuring compliance with ICH and FDA regulations. The ideal candidate will have 10 years of Regulatory Affairs experience and strong leadership skills. The position offers a competitive salary along with health insurance and generous PTO. #J-18808-Ljbffr
$150k - $194k
...we transform the lives of others.Position Summary:The Associate Director, Regulatory Affairs CMC will be responsible for supporting regulatory... ...Regulatory Affairs CMC to lead and prepare regulatory submissions (authoring, timeline planning, etc.), to support regulatory...SuggestedContract workLocal area$176.4k - $228.25k
...development and implementation of CMC regulatory strategy for small molecule investigational... ..., and best practices for CMC submissions and meetings. * Strategize, plan... ...The Team You’ll Join As Manager/Director CMC Regulatory Affairs you will be an essential member of...SuggestedLocal areaRemote workWork from homeWorldwide- ...Position Summary AD, Regulatory Affairs CMC is responsible for developing and implementing global regulatory CMC strategies to secure and... ...supplements/variations, clinical trial applications, and other CMC submissions. Author and lead CMC content for Health Authority meeting...SuggestedContract workLocal area
$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 portfolios... ..., mentor CMC Regulatory Affairs (RA) staff, supporting... ...regulatory impact and associated submission requirements for clinical...SuggestedWork at officeLocal areaRemote workWorldwideRelocation package3 days per week$130k - $200k
...Join to apply for the Associate Director Regulatory Affairs role at Tonix Pharmaceuticals Join to apply for the... ...develop regulatory strategies and submission plans. This position would be responsible... ..., Gene Therapy Associate Director, CMC Regulatory Affairs United States $17...SuggestedFull timeTemporary workWork at officeLocal areaRemote workFlexible hours- ...Associate Director/Director for Regulatory Affairs Padagis US LLC is seeking an experienced and dynamic Director or Associate... ...overseeing regulatory strategies, submission requirements and writing for... ...requirements for preclinical, clinical, and CMC submissions. Exceptional project...Remote work
- ...Description About the Role Late clinical‑stage rare disease company preparing for NDA & global submissions and commercial readiness is seeking a Director/Senior Director, Regulatory Affairs to join as their second regulatory hire. Reporting to the VP of Regulatory Affairs,...
$176.4k - $207.5k
...potential drug candidates to the clinic. We are seeking an Associate Director of Regulatory Affairs who will play a critical role in supporting global... ..., orphan drug designation applications, pediatric submissions, etc.). Create, collaborate and comply with disclosure...Odd jobWork at officeLocal areaImmediate startRemote workWork from home- ...Job Description This position in Regulatory Affairs involves the ability to integrate/apply... ...Management of regulatory activities associated with Company development programs.... ...completeness and accuracy of all regulatory submissions. Supervisory responsibility for the...Local areaRelocation package
$120k - $140k
...travel as needed. Position Summary Praxis’s Regulatory team is seeking an astute Senior Regulatory Submissions Manager who will oversee the operational aspects... ...plans in conjunction with Regulatory Affairs strategy and CMC leads, cross‑functional colleagues, and global...Work at officeLocal areaRemote workFlexible hours$115k - $145k
...excessive daytime sleepiness associated with narcolepsy and... ...a Manager/Senior Manager, Regulatory CMC. This role provides regulatory... ...will report to the Executive Director, Regulatory CMC. This... ...~ Tracks and archives submissions, correspondences, and commitments...Work at officeLocal areaRemote work3 days per week$125k - $145k
...bladder cancer treatment seeks a Manager of Regulatory Affairs. This remote role requires overseeing regulatory strategies and submissions while collaborating with cross-functional... ...regulatory experience, and knowledge of CMC and clinical requirements. The position offers...Remote workFlexible hours$274.8k - $354.8k
...BeiGene, Ltd. is seeking an Executive Director of Regulatory Affairs, CMC, to lead the U.S. Biologics Regulatory team. This pivotal role includes... ...activities for biologics, ensuring compliance and high-quality submissions across the product lifecycle. The ideal candidate will...Remote work$125k - $145k
...from you. About The Role The Manager, Regulatory Affairs will support the development and execution... ...programs, with a balanced focus on CMC and Clinical Regulatory Affairs. This role... ...IND through post‑approval). Regulatory Submissions & Documentation Draft, review, and...Contract workRemote workFlexible hours- ...seeking a highly organized and detail-oriented Senior Regulatory Affairs Associate to serve as a Regional Submission Coordinator . This is a key operational role... ...effective communication among all stakeholders including CMC, labelling, RRL, Local Regulatory Representative (...Work at officeLocal area
- ...Are you ready to make an impact at DTCC? As an Associate Director within DTCC's Regulatory Relations department, you will play a key role in shaping... ...: Tracking requests and ensuring timely submission of materials to regulators. Coordinating responses...Work at officeRemote workFlexible hours
$126k - $184.8k
...unmet needs. Position Overview The Associate Director, CMC Development will be responsible for the... ..., Supply Chain, R&D, Finance, and Regulatory to ensure delivery of CMC milestones... ...in support of IND, CTA and BNDA/MAA submissions. Partner closely with Development and...Full timeH1bWork at officeFlexible hours3 days per week$125k - $190k
...Opportunity? RBC Capital Markets (RBC CM) is looking for a regulatory data specialist responsible for simplifying complex FINRA regulatory... ...technology teams to remediate breaks and maintain regulatory submission accuracy. What will you do? * Analyze FINRA reporting...Full timeFlexible hours$142.8k - $192.8k
...fighting cancer.General Description:The Associate Director, Regulatory Business Operations will play a... .... Sitting within the Regulatory Affairs organization, this role serves as the... ...processes across clinical development, CMC, and submissions.Experience with dashboards,...Hourly payLocal area$165k - $220k
...globe. We have long been associated with many of the most significant... ...in the future. The Director, Regulatory Affairs leads global regulatory... ...with Clinical, Nonclinical, CMC, Quality, Safety, and... ...interactions, ensure highquality submissions, and manage regulatory...Temporary workWork visa- ...Job Title: Director, Regulatory Affairs Location: Remote Duration -3 months Description: Provides senior... ...hands-on leadership for regulatory submissions and interactions (e.g., FDA, EMA), including... .... Act as key liaison with clinical, CMC, and executive teams in a high-...Interim roleRemote work
- ...A leading generic pharmaceutical company is seeking an experienced Associate Director/Director of Regulatory Affairs to oversee regulatory strategies and manage submissions for pharmaceutical products. The role requires strong leadership in navigating FDA requirements,...Remote work
- ...tax compliance processes, including preparation and review of tax filings and document submissions. Manage tax withholding, reporting, and documentation processes to ensure regulatory compliance and operational accuracy. Oversee internal controls, risk assessments,...Local area
- ...Associate Director-Quality Assurance (QA-CMC) Company is seeking a highly experienced, motivated, and innovative quality leader with strong experience... .... This individual will partner with CMC, Clinical, Regulatory Affairs, and other corporate stakeholders to ensure Company...Contract workFor contractorsFlexible hours2 days per week1 day per week
$228k - $233k
...parenteral support. Job Overview The Director, Global Regulatory Affairs will lead Protara’s ex‑US regulatory... ...provide leadership on regulatory submissions (IND/CTA) outside the United States,... ...meetings. Strong understanding of CMC, nonclinical, and clinical requirements...Remote work- ...activities including assessments, strategies, submissions and agency interactions, applying expert knowledge in core area of regulatory practice (e.g., CMC, Medical Devices, CTAs, US etc.) and... ...of relevant experience in regulatory affairs or related functions in pharmaceutical...Local area
$155k - $205k
...significant progress toward our first regulatory approvals, with additional submissions targeted in the near future.... ...We’re seeking an experienced Director Regulatory Affairs, Clinical to serve as Loyal’s... ...across functions (including R&D, CMC, and commercial) throughout the...Home officeWeekend work$246.33k - $304.29k
Regulatory Affairs Remote - ID: 25R-27 - Full-Time/Regular This position is... .... We are seeking a Senior Director, Regulatory Affairs to play... ...oversee IND/CTA and NDA/sNDA submissions, and represent Regulatory Affairs... ...(e.g., Product, Clinical, CMC). Proactively identify and...Full timeWork at officeRemote workRelocationFlexible hours$270k - $300k
...Title: Executive Director, Regulatory Affairs Location: Remote (West Coast hours preferred) Reports to... ...while partnering closely with Clinical, CMC, Commercial, Market Access, and Legal... ...to the preparation, review, and submission of INDs, CTAs, BLAs/MAAs, briefing packages...Remote work$90 - $100 per hour
...Key Duties & Responsibilities Manages portfolio views of upcoming submissions and publishing interdependencies and serves as Global Regulatory Publishing subject matter expert Serve as primary point of contact between cross‑functional team and regulatory publishing vendor...Contract workRemote workMonday to FridayShift work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Associate Director, Regulatory Affairs CMC - Submissions. Be the first to apply!
- associate director New York, NY
- associate director marketing New York, NY
- associate brand manager New York, NY
- associate media manager New York, NY
- associate client manager New York, NY
- associate media director New York, NY
- associate creative manager New York, NY
- associate creative director copy New York, NY
- associate medical director New York, NY
- associate strategy director New York, NY

