Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

CMC Regulatory Director - Gene Therapy Submissions

$204k - $244k

Scorpion 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

Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the CMC Regulatory Director - Gene Therapy Submissions in Cranbury, NJ vacancy
  • $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

    Jobleads-US

    Cranbury, NJ
    1 day ago
  • $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,... 
    Suggested
    Temporary work

    Scorpion Therapeutics

    Cranbury, NJ
    1 day ago
  • $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

    Rocket Pharmaceuticals

    Cranbury, NJ
    1 day ago
  •  ...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... 
    Suggested
    Flexible hours

    Bristol-Myers Squibb

    New Brunswick, NJ
    2 days ago
  •  ...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

    Jobleads-US

    Plainsboro, NJ
    1 day ago
  • $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 contractors
    Local area

    Taiho Oncology, Inc.

    Princeton, NJ
    1 hour ago
  • $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 work
    Local area
    Shift work

    Rocket Pharmaceuticals

    Cranbury, NJ
    1 day ago
  • $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 area
    Flexible hours
    Night shift

    Merck & Co. Inc

    Plainsboro, NJ
    1 day ago
  • $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 office
    Remote work

    NACBA

    Princeton, NJ
    1 day ago
  • $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 office
    Local area
    Flexible hours
    Night shift

    Initial Therapeutics, Inc.

    Plainsboro, NJ
    2 days ago
  •  ...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... 

    Careers Integrated Resources Inc

    Hightstown, NJ
    1 day ago
  • $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 work
    Work at office
    Flexible hours

    Ascendis Pharma A/S

    Princeton, NJ
    2 days ago
  •  ...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

    Lynkx Staffing LLC

    Princeton, NJ
    a month ago
  •  ...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 work
    Work at office
    Local area

    Kyowa Kirin

    Princeton, NJ
    8 days ago
  • $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 time
    Work at office
    Shift work

    Tris Pharma

    Monmouth Junction, NJ
    2 days ago
  • $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 work
    Work at office
    Local area
    Flexible hours

    Otsuka America Pharmaceutical Inc.

    Princeton, NJ
    2 days ago
  •  ...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)... 

    Lupin

    Somerset, NJ
    3 days ago
  • $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 work
    Work visa

    Bausch + Lomb

    Princeton, NJ
    4 days ago
  •  ...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... 

    Vibrant Ingredients

    Cranbury, NJ
    2 days ago
  • $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 pay
    Full time
    Temporary work
    Part time
    For contractors
    Summer work
    Work at office
    Remote work
    Worldwide
    Flexible hours

    Bristol Myers Squibb

    Princeton, NJ
    1 hour ago
  • $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... 

    Summit Therapeutics

    Princeton, NJ
    6 days ago
  • $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 pay
    Full time
    Temporary work
    Part time
    For contractors
    Summer work
    Live in
    Work at office
    Local area
    Remote work
    Flexible hours
    Shift work

    Bristol Myers Squibb

    Princeton, NJ
    1 day ago
  • $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

    Eclaro

    Lawrence, NJ
    4 days ago
  • $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 pay
    Full time
    Temporary work
    Part time
    For contractors
    Summer work
    Live in
    Work at office
    Local area
    Remote work
    Flexible hours
    Shift work

    Bristol-Myers Squibb Company

    Princeton, NJ
    6 days ago
  • $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 office
    Remote work
    Relocation package
    Flexible hours

    Sandoz

    Princeton, NJ
    4 days ago
  •  ...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 work
    Local area
    Worldwide

    TechDigital Group

    New Brunswick, NJ
    1 day ago
  • 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...

    Initial Therapeutics, Inc.

    Plainsboro, NJ
    1 day ago
  • $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 pay
    Full time
    Temporary work
    Part time
    For contractors
    Summer work
    Live in
    Work at office
    Local area
    Remote work
    Flexible hours
    Shift work

    Bristol-Myers Squibb Company

    Princeton, NJ
    4 days ago
  • $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 pay
    Full time
    Temporary work
    Part time
    For contractors
    Summer work
    Live in
    Work at office
    Local area
    Remote work
    Flexible hours
    Shift work

    Bristol-Myers Squibb Company

    Princeton, NJ
    4 days ago
  • $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

    First Commerce Bank

    Dayton, NJ
    4 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to CMC Regulatory Director - Gene Therapy Submissions. Be the first to apply!