Regulatory Affairs CMC Manager - Submissions & FDA Liaison
Daiichi Sankyo
Daiichi 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 5-8 years in the pharmaceutical industry, with a bachelor's degree in a scientific discipline being essential. The position offers opportunities to influence regulatory strategy and contribute to innovative medicines while supporting the broader regulatory team. #J-18808-Ljbffr Daiichi Sankyo
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Regulatory Affairs CMC Manager - Submissions & FDA Liaison in Basking Ridge, NJ vacancy
$127.28k - $190.92k
...This position serves as the Regulatory Affairs (RA) CMC project representative to... ...broader RA team. This position manages assigned developmental and... ...team in the preparation of submission documents (e.g., IND, BLA,... ...by higher-level manager. FDA Interactions: Leads FDA interactions...Suggested$140k - $165k
...Job Description Senior Manager CMC Regulatory A Partner to Actalent is seeking... ...Manager of CMC Regulatory Affairs to lead regulatory strategy... ..., and full compliance with FDA expectations. The position... ..., drive high‑quality submissions, and collaborate effectively...SuggestedPermanent employmentTemporary workActalent
Morristown, NJ9 days ago$199.95k - $242.3k
...com/working-with-us . The GRS-CMC Director is responsible for overseeing management of multiple development and life... ...direction based on global regulatory guidelines and experience. Seeks... ...Prepare or oversee preparation of CMC submissions while ensuring thoroughness,...SuggestedHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift workBristol-Myers Squibb
Madison, NJ2 days ago- ...area. Associate Director in the Regulatory Affairs CMC Department. The successful candidate... ...applications, and post-authorization submissions for biological substances and... ...information to project teams and senior management in a timely manner. Initiates local...SuggestedContract workLocal area
Fladger Associates
Morris Plains, NJ1 day ago $165k - $220k
...health in the future. The Director, Regulatory Affairs leads global regulatory strategy,... ...crossfunctionally with Clinical, Nonclinical, CMC, Quality, Safety, and Regulatory... ...interactions, ensure highquality submissions, and manage regulatory risk across the product lifecycle...SuggestedTemporary workWork visaBausch + Lomb
Basking Ridge, NJ3 days ago- ...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...
6084-Janssen Research & Development, LLC Legal Entity
Raritan, NJ4 days ago $170k - $200k
...Description Job Description Head of Regulatory Affairs Morris County, NJ (On-Site) Our... ...compliance, product lifecycle management, and FDA alignment while partnering cross-functionally... ...full regulatory lifecycle-strategy, submissions, compliance, and post-market-...Local areaLHH US
Morristown, NJ21 days ago- ...A leading tech firm is seeking a Product Manager with extensive experience in regulatory submission processes and health authority queries. The role requires strong customer-facing skills and a deep understanding of pharma regulatory processes. Candidates with over 10...
TechDigital Group
Raritan, NJ3 days ago - ...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...
Bristol-Myers Squibb
Madison, NJ6 hours ago - ...in non-opioid pain management and regenerative... ...leadership role will drive regulatory strategy across... ...Guide complex FDA and Health... ...Development, Nonclinical, CMC, Commercial, and... ...pharmaceutical Regulatory Affairs experience ~... ...regulatory submissions and Health Authority...
Kaye/Bassman International
Parsippany, NJ4 days ago $184.24k - $276.36k
...Job Summary The Director, Regulatory Affairs Advertising and Promotion (RAAP) provides senior strategic... ...communications in alignment with FDA regulations, guidance, enforcement trends... ...Guide and support required promotional submissions, including Form FDA 2253, SubpartE/H,...Work at officeInitial Therapeutics, Inc.
Basking Ridge, NJ4 days ago- ...Senior Manager/Director, Regulatory Affairs (Generalist) Are you a regulatory affairs leader... ...on development pathways, submission strategy, and health... ...regulatory agencies, including the FDA Develop health authority... ...and milestone activities CMC Regulatory Support,...
G&L Scientific
Madison, NJ6 hours ago - ...be identifying and assessing regulatory and quality risks during site... ...inspection program. They will manage routine use of the Cellares... ...implementation plans Contribute to CMC sections of regulatory... ...in preparing regulatory submissions and response to health authorities...Flexible hours
Cellares
Bridgewater, NJ20 days ago $175k - $210k
...Medical Science Liaison The Medical Science Liaison... ...of the Medical Affairs Organization that supports... ...relationship building and management of KOLs providing for... ...-initiated research submissions studies. Delivers,... ...internal groups (Clinical, Regulatory, Commercial (Sales and...Full timeLocal areaFlexible hours3 days per week$185k - $215k
...Medical Science Liaison - Southeast Region (FL, GA,... ...Ipsen's U.S. Medical Affairs Neuroscience team. This... ...and complies with all regulatory and compliance requirements... ...in disease state management, emerging therapies, and... ...ISS) and supports ISS submissions, initiation and...Temporary workWork experience placementLocal areaHome officeFlexible hours- ...Medical Science Liaison, Rare Disease (Central) Ipsen... ...Ipsen's U.S. Medical Affairs Rare Disease team.... ...and complies with all regulatory and compliance requirements... ...in disease state management, emerging therapies, and... ...ISS) and supports ISS submissions, initiation and closure...Work experience placementLocal areaHome office
$185k - $215k
Medical Science Liaison - Midwest Region (IL, WI, IA... ...Ipsen’s U.S. Medical Affairs Neuroscience team. Responsible... ...compliance with regulatory and internal standards... ...and support ISS submissions, initiation, and closure... ...fundamentals. Excellent project management ability. Strong...Temporary workWork experience placementLocal areaHome officeFlexible hours$185k - $215k
Medical Science Liaison - Tristate / Pennsylvania Region... ...Ipsen’s U.S. Medical Affairs Neuroscience team.... ...regarding operational management. Partner with Medical... ...and adherence to legal, regulatory and Ipsen guidelines.... ...(ISS) and support ISS submissions, initiation and closure...Temporary workLocal areaFlexible hours$185k - $215k
Medical Science Liaison - South Region (TX, MO, LA,... ...within the U.S. Medical Affairs Neuroscience team,... ...information in compliance with regulatory and internal... ...studies (ISS) through submissions, initiation and closure... ...research and project management ability. Strong oral and...Temporary workWork experience placementLocal areaFlexible hours$185k - $215k
Medical Science Liaison - Mid‑Atlantic Region (NC, SC... ...Ipsen’s U.S. Medical Affairs Neuroscience team. The... ...feedback on operational management to ensure optimal site... ...adherence to legal, regulatory, and Ipsen guidelines,... ...(ISS) and support ISS submissions, initiation, and closure...Temporary workWork experience placementLocal areaHome officeFlexible hours$185k - $215k
Medical Science Liaison - Great Lakes Region Position... ...Ipsen’s U.S. Medical Affairs Neuroscience team. The... ...and adherence to legal, regulatory, and Ipsen guidelines... ...(ISS) and support ISS submissions, initiation, and... ...communications. Strong project‑management abilities. Thorough...Work experience placementLocal areaHome office$185k - $215k
...Summary Medical Science Liaison - Southern California... ...Ipsen’s U.S. Medical Affairs Neuroscience team, responsible... ...adherence to legal, regulatory, and Ipsen guidelines.... ...(ISS) and support ISS submissions, initiation, and... ...environment. Excellent project management and leadership...Temporary workWork experience placementLocal areaFlexible hours$130k - $200k
...August 2025, Tonix received FDA approval for Tonmya™ (cyclobenzaprine... ...Director Thought Leader Liaison (TLL), Fibromyalgia, will... ...engagement, executive encounter management, and supporting the... ...Understanding of legal and regulatory issues impacting pharmaceutical...Temporary workWork at officeLocal areaFlexible hoursNight shiftTonix Pharmaceuticals
Berkeley Heights, NJ1 day ago- ...Head of Regulatory Affairs About the Company Respected provider of top... ...that all products meet FDA standards and are in line with... ...owning end-to-end lifecycle management, and partnering with cross-functional... ...in regulatory strategy, submissions, and compliance. Strong...
$127.53k - $236.84k
...protocol and budget development to submission and completion for Phase IV... ...sales and Corporate Account Managers (CAM's) Document and forward... ...organizations Assist Medical Affairs as well as agency personnel... ...skills Working knowledge of FDA and OIG requirements as well...Full timeTemporary workLocal area$205k - $341.6k
...The Director Regulatory Affairs will provide leadership on global regulatory... ...supervise IND/CTA and BLA submissions activities. In this role,... ...excellent negotiation and project management skills as evidenced by past... ...strong understanding of US FDA and international...Local areaRelocation packageRegeneron Pharmaceuticals
Warren, NJ2 days ago$215k - $240k
...dermatology by driving regulatory strategy for LEO Pharma... ...primary U.S. Regulatory Affairs representative for... ...Global Regulatory Lead. Manage the coordinated preparation and timely submission and approval of regulatory... ...leadership of Health Authority (FDA) interactions. Provide...Permanent employmentContract workWork at officeLocal areaJobRx, Inc.
Madison, NJ4 days ago- ...Job Description Title: Regulatory Manager Location: Warren, NJ 0... ...Description: Regulatory Affairs Senior Manager Job Purpose... ...deliver timely approvals for US submissions and OTC Monograph product... ...affairs Experience working on FDA applications, OTC monograph...Work at officeLocal areaDay shift
Lancesoft INC
Warren, NJ15 days ago - ...via Aqua-Swirl, Aqua-Filter, and Aqua-Ponic products. The Regulatory Manager will support the commercial growth of its stormwater... ...and approval Prepare, coordinate, and track regulatory submissions across municipalities, agencies, and certification programs...
Komline Sanderson
Peapack, NJ7 days ago - ...vascular access and medication management. Our mission is to improve... ...: The Director, Regulatory Affairs is responsible for leading and... ...direct authorship of complex submissions (e.g., 510(k)s), regulatory... ...preparation and management of U.S. FDA and global regulatory...Worldwide
Spectrum Vascular
Warren, NJ26 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs CMC Manager - Submissions & FDA Liaison. Be the first to apply!
Related searches
- senior medical science liaison Basking Ridge, NJ
- regulatory law Basking Ridge, NJ
- regulatory contract Basking Ridge, NJ
- regulatory Basking Ridge, NJ
- compliance lead Basking Ridge, NJ
- pharmaceutical regulatory affairs Basking Ridge, NJ
- customs compliance Basking Ridge, NJ
- vendor compliance Basking Ridge, NJ
- regulatory affairs assistant Basking Ridge, NJ
- regulatory affairs Basking Ridge, NJ