CMC Regulatory Affairs Manager — Drive Submissions & FDA Interactions
Initial Therapeutics, Inc.
Initial Therapeutics, Inc. is seeking a Manager of Regulatory Affairs - CMC. This role involves managing developmental and post-marketing projects while ensuring compliance with US regulations. The manager will oversee the preparation of submission documents and lead FDA interactions. The ideal candidate will have significant experience in the pharmaceutical industry, particularly in CMC regulatory roles, with a Bachelor's degree in a scientific discipline being necessary. A blend of expertise in both regulatory affairs and project management will be essential for success in this position. #J-18808-Ljbffr Initial Therapeutics, Inc.
- ...Sankyo in Basking Ridge, New Jersey, is seeking a Manager for Regulatory Affairs - CMC. The role involves managing developmental and post marketing projects, preparing submission documents, and leading FDA interactions under supervision. The ideal candidate will have 5...Suggested
- EmergencyMD is seeking a regulatory CMC specialist to provide global regulatory support... ..., New Jersey. The role involves managing high-quality CMC regulatory submissions and ensuring timely execution of... ...and the ability to interpret FDA regulations. #J-18808-Ljbffr EmergencyMDSuggested
$199.95k - $242.3k
## Director, Regulatory CMC - Cell TherapyMadison - Giralda... ...for overseeing management of multiple development... ...oversee preparation of CMC submissions while ensuring... ...independently* Ability to interact with CMC technical... ...demonstrated ability to drive quality decision-...SuggestedHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$127.28k - $190.92k
Job Title: Manager, Regulatory Affairs - CMC Job Requisition ID: 1525 Posting Start Date: 6/1/26 At Daiichi... ...team in the preparation of submission documents (e.g., IND, BLA, IB, NDA... ...review by higher‑level manager. FDA Interactions: Lead FDA interactions with a high...Suggested- ...collaboration, determination and a relentless drive to make a difference. Every member of... ...of patients for generations to come. Regulatory Submission Management acts as a partner for strategic... ...trusted companion across Regulatory Affairs, bridging strategy and execution...SuggestedFull timeFor contractorsWork at officeLocal areaWorldwideFlexible hours
$184.24k - $276.36k
Job Summary The Director, Regulatory Affairs Advertising and Promotion (RAAP... ...in alignment with FDA regulations, guidance, enforcement... ...required promotional submissions, including Form FDA 2253, Subpart... .... Support ad/promo interactions with OPDP and other regulatory...Work at office- HUTCHMED is seeking a (Sr.) Director of Regulatory Affairs to establish and lead the Regulatory Affairs function. This role involves supporting... ...provide regulatory guidance leveraging their expertise, manage submissions, and develop timelines in coordination with global...
- ...Entity is seeking a Director, Technology Product Group Leader for Submission Excellence. This role involves overseeing the development,... ...engineering, and global operationalization of solutions to accelerate regulatory submissions. The ideal candidate will have extensive...
- ...Head of Regulatory Affairs About the Company Respected... ...pivotal leadership role in driving U.S. regulatory... ...that all products meet FDA standards and are in... ...end-to-end lifecycle management, and partnering with... ...regulatory strategy, submissions, and compliance. Strong...
- Bristol-Myers Squibb is seeking a Director, Regulatory CMC for Cell Therapy in Madison, NJ. In this pivotal role, you will oversee multiple development and lifecycle management projects, ensuring regulatory compliance and strategic direction in alignment with global guidelines...
- ...Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL... ...regulatory requirements. Manages compounds through all phases... ...regulatory position in interactions at Joint Governance. Make... ...operating with integrity, driving innovation, transforming lives...Local areaWorldwide
$122.25k - $176.58k
Job Title Manager Regulatory Affairs Advertising and Promotion Location Morristown, NJ & Cambridge, MA... ..., AI‑powered research. In R&D, you’ll drive breakthroughs that could turn the impossible... ...and be the primary liaison with FDA on advertising and promotional compliance...$225k - $305k
...promotional activities—driving both operational... ...Provide management, leadership, and development... ...expert on FDA regulations, guidance... ..., ensuring timely submissions. Develop and implement... ...as the senior regulatory representative on... ...within the Regulatory Affairs area and with...Permanent employmentContract workWork at office- ...Job Description The Senior Manager, Regulatory Affairs US Advertising and Promotion... ...Federal Regulations (CFR), FDA guidance documents, PhRMA... ...fostering mutually beneficial interactions and exchange. This role... ...operating with integrity, driving innovation, transforming lives...
- The (Sr.) Director, Regulatory Affairs role will establish Regulatory Affairs... ..., approval and timely submission of regulatory filings, including... ...contact for HUTCHMED with US FDA and other health authorities... ...global product team and management of communications with health...
- ...Financial Planning and Analysis Manager is responsible for providing... ...flow, and sales outlook for submission to management and global FP&A... ...skills with the ability to interact with all levels of the organization... ...and business acumen, able to drive projects from start to finish...Flexible hours
$150k - $240k
...payment solutions. You will guide regulatory strategy for embedded... ...program capabilities clearly. Drive alignment across compliance,... ..., Finance, Law, Risk Management or related field or equivalent... ...Fiserv does not accept resume submissions from agencies outside of existing...Temporary workH1bWork at officeMonday to Friday$153.6k - $230.4k
...Strategic Partner Management Job Requisition ID... ..., and proactively drive operational... ...Pharmacovigilance Practice and regulatory compliance in such... ..., Regulatory Affairs Facilitate... ...Safety Information submission to Health Authorities... ...GVP) Knowledge of FDA regulations, clinical...Contract workLocal area$225k - $275k
...Senior Director of Regulatory Affairs - Cluster (North America... ...authorities (e.g., FDA and Health Canada),... ..., market risk management, and submission readiness, working in... ...business partnering Drive alignment and ways of... ...including health authority interactions. ~ Strong...Work at officeLocal areaRemote work2 days per week- ...access and medication management. Our mission is to... ...Description: The Regulatory Affairs Manager is a seasoned... ...current and new product submissions in the US and globally... ...submissions, interact with regulatory agencies... ..., and maintenance of FDA 510K filings in accordance...Work at officeLocal areaRemote workWorldwide
- ...access and medication management. Our mission is... ...The Director, Regulatory Affairs is responsible for... ...of complex submissions (e.g., 510(k)s),... ...assessments, and agency interactions. This individual... ...management of U.S. FDA and global... ...notified bodies. Drive regulatory strategy...Worldwide
- ...to serve as Summer Employment Operations Manager. This seasonal leadership role (... ...onboarding requirements before Day 1. Regulatory Oversight Execute a comprehensive compliance... ...enrollment‑based pay to ensure accuracy before submission to HR Services. Maintain Greenhouse as...Hourly payFull timeSummer workSeasonal workImmediate start
$145k - $240k
...implementing, and defending tax planning initiatives. This will require interaction and alignment with various groups across the enterprise. The... ..., acquisition strategies, and other initiatives to drive shareholder value. Lead technical tax research, calculation, and...Temporary workH1bWork at officeMonday to Friday$119.5k - $179k
...TX / Morristown, NJ Title: Compliance Manager - Spinnaker Location: Austin, TX / Dallas... ..., NJ (hybrid) Reports To: Director, Regulatory Compliance About Hippo Hippo exists to... ...jurisdictions Own the preparation, validation, and submission of recurring monthly, quarterly, and...Work at office- ...appropriate Quality Management System (QMS)... ...ensuring compliance with FDA, EMA, all... ...external audits. Drive inspection readiness... ...audits, responses to regulatory inspections,... ...Lead preparation, submission and maintenance of... ...and/or Regulatory Affairs within regulated advanced...Contract workWork at officeRelocationFlexible hours
$100k - $150k
...deliver highly personalized risk and claims management through a blend of expert independent... ...Curiosity, creativity, and a drive to challenge the status quo Collaboration... ...opportunity employer. Responsibilities As our Regulatory Compliance Manager , you’ll report to the...Full timeWork at officeRemote work$122.25k - $176.58k
Job Title: Senior Manager, Regulatory Affairs Advertising and Promotion Location: Morristown, NJ / Cambridge, MA About the Job As the Senior Manager... ...and development projects, and be the primary liaison with FDA on advertising and promotional compliance for assigned...$184.24k - $276.36k
Merck & Co. is seeking a Director, Regulatory Affairs Advertising and Promotion to provide strategic regulatory leadership for U.S. promotional... ...involves guiding compliant communications in alignment with FDA regulations while leading cross-functional collaboration. The...$122.25k - $176.58k
Sanofi is seeking a Manager for Regulatory Affairs Advertising and Promotion in Morristown, NJ. As the regulatory lead, you will oversee the independent... ...strategies and act as the primary contact with the FDA for compliance matters. This position offers a competitive...$150k - $258.75k
...compliance efforts, ensure effective risk management and drive operational excellence for MedTech... ...health care products and services, interactions with health care professionals (HCPs... ...appropriate individuals within HCC, Regulatory Affairs, Government Contracting & Compliance...Full timeLocal areaImmediate start
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