CMC Regulatory Director - Gene Therapy Submissions
$204k - $244kScorpion Therapeutics
Scorpion Therapeutics is seeking a Director, Regulatory Affairs – CMC in Cranbury Township, New Jersey. This role involves developing and executing global Regulatory-CMC strategies for gene therapy products, leading the preparation and review of submission documents, and interacting with health authorities. The ideal candidate will have 12 years of Regulatory Affairs experience, including at least 8 years focused on CMC, preferably within the pharmaceutical industry. A competitive salary range of $204,000 to $244,000 is offered, alongside comprehensive benefits including bonuses, medical, and retirement plans. #J-18808-Ljbffr
$360k - $400k
...Rocket Pharmaceuticals is seeking a Senior Vice President (SVP) of Regulatory Affairs to drive regulatory strategies for innovative gene therapies. This key leadership role involves overseeing regulatory interactions with global health authorities and guiding regulatory...Suggested$204k - $244k
...Director, Regulatory Affairs – CMC (Chemistry, Manufacturing, and Controls) Responsibilities Work collaboratively... ...of Regulatory-CMC strategies for gene therapy products. Develop, propose, and... ...Lead the preparation/review of CMC submission documents, registration dossiers,...SuggestedTemporary work$232k - $277k
...Rocket Pharmaceuticals is seeking a Senior Director, Quality Assurance - Commercial &... ...ensuring compliance with commercial and regulatory standards, and overseeing all Quality Assurance functions related to gene therapies. The ideal candidate will have over 15 years...Suggested- ...Bristol-Myers Squibb is seeking a Manager for CMC Documentation in New Brunswick, NJ. The role involves compiling and authoring CMC sections of regulatory submissions, coordinating with various teams to ensure timely document delivery. Ideal candidates will have a degree...SuggestedFlexible hours
- ...Merck & Co. is seeking a Head of Regulatory Affairs in Plainsboro Township, NJ. This role involves defining and leading regulatory strategy for product submissions and approvals, and engaging with the U.S. FDA to ensure compliance. Candidates must have a doctorate or...Suggested
$212.5k - $250k
...Join Taiho Oncology as Director for Regulatory CMC Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology... ...a pivotal and visible role in advancing CMC strategy and submissions of developmental, life cycle and post approval projects...For contractorsLocal area$232k - $277k
...-stage biotechnology company advancing gene therapies with curative potential for patients with... ...benefits. Position Summary The Senior Director, Quality Assurance - Commercial &... ...responsible for all Quality interactions with regulatory health authorities. Responsibilities...Temporary workLocal areaShift work$187.1k - $327.5k
...accountable every step of the way as we develop therapies and bring them to market. At Novo... ...? The Position Reporting to the Senior Director, Ethics & Compliance (E&C), this role serves... .... Continuously monitor the external regulatory landscape to anticipate emerging risks and...Local areaFlexible hoursNight shift$132.48k - $198.72k
...commercialization of transformative therapies.We are seeking an... ...thinking Senior Manager, Medical, Regulatory and Legal (MeRL) Operations,... ...position reports to the Director of MeRL Operations within Genmab... ...Ensure timely and compliant submission, routing, review, and...Work at officeRemote work$153k - $267k
...Affairs professionals ensure that the latest therapies and products reach the people who need... ...broader framework established by the Director of Program Management. This role is responsible... ...impact timelines Oversee the structured submission process for project proposals, ensuring...Work at officeLocal areaFlexible hoursNight shift- ...IT), Clinical Research, Rehabilitation Therapy and Nursing./ph3Job Description/h3p Create... ...approach to the company quality and regulatory system./pp Ensure all GMP, GLP, GCP operations... ...to approval./pp Prepare and submit submissions and ensure compliance with all...
$160k - $175k
...and potentially best-in-class therapies to address unmet medical... ...and develop their skills. The Regulatory Project Manager will be an integral... ...to key global regulatory submissions across the Ascendis pipeline... ...Partner or Human Resources Director) is not allowed. If this...Temporary workWork at officeFlexible hours- ...Description Our Pharmaceutical client is seeking a Director Regulatory Affairs Chemistry Manufacturing & Controls (CMC) to guide global teams through the development... ...required. Prior experience with authoring, submission, and approval process of a major marketing...Work at office
- ...Associate Director, Regulatory Affairs Advertising & Promotion Compliance Princeton, New Jersey... ...science into smiles by delivering therapies where no adequate treatments currently... ...preparation of FDA Form 2253 submissions and any requests for advisory comment...Summer workWork at officeLocal area
$200k - $245k
...Junction, NJ offices for an experienced Regulatory Affairs Director to support a 505(b)(1) New Chemical... ...responsibility for day-to-day NDA submission management and delivery. You will function... ...Regulatory Lead across Clinical, CMC, Nonclinical, Biostatistics, Medical...Full timeWork at officeShift work$150.03k - $224.25k
...Provides critical support in developing global regulatory strategy, planning and execution of... ...and marketed prescription drug submissions and manages lifecycle activities for all... ...global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory...Temporary workWork at officeLocal areaFlexible hours- ...Senior Director, Regulatory Affairs Date: May 23, 2026 Location: Somerset, NJ, US Company: Lupin... ...and HORA, reviewing ANDAs pre- or post-submission, proactively working with cross-functional... ...Drug development experience required (CMC and PK/PD Clinical development)...
$165k - $220k
...advancement of eye health in the future. The Director, Regulatory Affairs leads global regulatory... ...with Clinical, Nonclinical, CMC, Quality, Safety, and Regulatory Operations... ...authority interactions, ensure highquality submissions, and manage regulatory risk across the...Temporary workWork visa- ...our innovation team to discover new, on trend solutions. As a Regulatory Manager , you will oversee day-to-day regulatory operations,... ..., Kosher/Halal certs, COO, Prop 65, flavor labeling, TTB submissions, and more). Support global market-entry requirements through...
$200.43k - $242.87k
...Director, Compliance and Ethics Organization - Commercial, CV Working with Us Challenging... ...to the latest breakthroughs in cell therapy, this is work that transforms the lives... ...Medical, R&D, Global Drug Development, Regulatory, IT, Audit, Finance and HR to build and...Hourly payFull timeTemporary workPart timeFor contractorsSummer workWork at officeRemote workWorldwideFlexible hours$245k - $307k
...Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China's National... ...of Market Access, the Executive Director, US Market Access Strategy is... ...Regulatory, Legal, Finance, Brand, CMC, Marketing, Sales, and Commercial...$258.68k - $313.46k
...Senior Director, Global Regulatory Strategy, Neuroscience This role will require neuroscience experience... ...the regulatory product managers (submissions) and regulatory operations group, for... ...or more key areas Drug Development/CMC/Pharmtox/Biopharmaceutics/Clinical/Promotional...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$75.83 - $80.43 per hour
...Regulatory & Medical Affairs - Project Manager Job Number: 26-00704 Be part of a company that delivers life-changing healthcare solutions... ...commercial operations processes. Experience with specific therapy area launches (oncology, immunology, etc.). Familiarity with UI...Shift work$251.08k - $304.25k
...latest breakthroughs in cell therapy, this is work that... ...reimbursement positioning. Guide HTA submissions and payer negotiations for... .... Ensure adherence to regulatory and corporate standards across... ...Ripley. R1601103 : Executive Director, RayzeBio Market Access...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$145.6k - $279.4k
...Description: Leads and manages the preparation, review, and submission of regulatory applications, including product registrations, progress... ...leadership and guidance in partnership with Clinical, Nonclinical, CMC, Analytical Development, Quality, Pharmacovigilance, Medical...Work at officeRemote workRelocation packageFlexible hours- ...Regulatory Operations/Affairs Manager Onsite role New Brunswick, NJ... ...report directly to the Associate Director, Regulatory Affairs and will... ...plans, and regulatory submission plans. Maintains strong communication... ...and global personnel such as CMC. Participating in other QA...Contract workLocal areaWorldwide
- Initial Therapeutics, Inc. is seeking a strategic compliance advisor to work closely with senior leaders across various functions, including Legal and HR. The ideal candidate will have over 12 years of experience in compliance and legal roles within the life sciences sector...
$202.03k - $244.81k
...optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the... ...personal lives. Read more: careers.bms.com/working-with-us . The Director, Portfolio Governance & Congress Strategy provides department‑...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$229.38k - $277.96k
...optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the... ...inform and shape long-range portfolio strategy. The Senior Director, Strategic Alliances is an enterprise level leadership role within...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$90k
...minimum of seven (7) years of equivalent experience in banking and regulatory compliance required. Certified Regulatory Compliance Manager (... ...personal communications beginning with the Board of Directors. First Commerce Bank is an Equal Opportunity Employer. All...Local area
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