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

Senior Manager, Regulatory Affairs - CMC (Hybrid)

Shionogi Inc.

Shionogi is seeking a Senior Manager, Regulatory Affairs, Chemistry, Manufacturing, and Controls in Florham Park, NJ. The hybrid role blends strategic regulatory leadership with hands-on CMC submissions and compliance activities. You will coordinate cross-functional teams, prepare filings, and ensure timely approvals to support product development and lifecycle management. The position requires extensive regulatory experience in CMC, strong collaboration, and a proven track record of delivering #J-18808-Ljbffr

Vacancy posted 8 hours ago
Similar jobs that could be interesting for youBased on the Senior Manager, Regulatory Affairs - CMC (Hybrid) in Florham Park, NJ vacancy
  • Shionogi Inc. in Florham Park, NJ, seeks a Senior Manager, Regulatory Affairs CMC to lead strategy and coordination of CMC regulatory activities under...  ...requires five years in regulatory affairs with CMC focus; hybrid work 2-3 days on-site at US HQ; travel as needed. #J-18... 
    Senior

    Shionogi Inc. (U.S.)

    Florham Park, NJ
    4 days ago
  • $140k - $170k

     ...Overview The Senior Manager, Regulatory Affairs CMC supports the CMC team under the guidance of the Senior Director, CMC. In this role, the Senior...  ...Ability to travel via automobile and/or airplane. Hybrid work arrangements will allow work from home combined with... 
    Senior
    Full time
    Local area
    Work from home
    2 days per week
    3 days per week

    Shionogi Inc.

    Florham Park, NJ
    4 days ago
  • $140k - $200k

    Overview The Senior Manager/Associate Director, Regulatory Affairs CMC is a strategic and hands on regulatory contributor responsible for defining and executing global CMC regulatory strategies for assigned investigational and/or marketed assets. The role partners closely... 
    Senior
    Full time
    Work at office
    Local area

    Shionogi Inc.

    Florham Park, NJ
    4 days ago
  •  ...Instagram ,  X and  YouTube. Job Description The  Senior Manager Regulatory Affairs US Advertising and Promotion-Immunology combines knowledge...  ...interactions and exchange. This role will work a hybrid work schedule (3 days in office & 2 days remotely) from one... 
    Senior
    Full time
    Work at office
    Local area
    Remote work

    AbbVie

    Florham Park, NJ
    1 day ago
  •  ...Instagram, X and YouTube. Job Description The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada is responsible for the development...  ...Dossier Program (QDP). This role will work a hybrid work schedule (3 days in office, 2 days remotely) from... 
    Senior
    Work at office
    Remote work

    AbbVie

    Florham Park, NJ
    10 hours ago
  •  ...Job Title: Global Regulatory CMC Manager Location: Giralda Farms, NJ , 07940 Duration: 6 Months Hybrid- 50% onsite Hours: Mon-Fri 8am-5pm Summary: The GRS-CMC...  ...Development Operations (CTDO). The GRS-CMC Senior Manager II will assess Manufacturing... 
    Full time

    Sunrise Systems, Inc.

    Madison, NJ
    3 days ago
  •  ...pending and approved applications. Lead, guide, and train the CMC team to ensure highly qualified personnel that can perform to...  ...and monitoring of PLAIR activities, prior to new product launch Manage regulatory correspondence mainly to CDER, FDA, User fee staff, drug... 
    Senior
    Local area

    Katalyst Healthcares & Life Sciences

    Madison, NJ
    8 days ago
  •  ...Kite, a Gilead subsidiary, seeks a Manager in Regulatory Affairs focused on Chemistry, Manufacturing, and Controls (CMC) for cell and gene therapies. The role involves preparing regulatory submissions, developing CMC strategies, and collaborating across functions to support... 

    Gilead Sciences

    Parsippany, NJ
    20 days ago
  • $133.2k - $172.37k

     .... Job Description This is an office based/hybrid position. The Manager, Regulatory Affairs CMC is located in Philadelphia PA, El Segundo, CA or Thousand...  ...global CMC regulatory strategies under guidance of senior staff for both cell therapy products and lentiviral... 
    Full time
    Contract work
    For contractors
    Work at office
    Local area
    Remote work
    Relocation
    Flexible hours

    Gilead Sciences

    Parsippany, NJ
    a month ago
  • AXIS Capital is seeking a Senior Manager for Quality Assurance and Compliance in North America Claims. The role...  ...across multiple lines of business, with a focus on regulatory compliance and operational excellence in a hybrid in-office setting. #J-18808-Ljbffr AXIS (AXIS... 
    Senior
    Work at office

    AXIS (AXIS Capital)

    Short Hills, NJ
    2 days ago
  • $139.8k - $209.7k

    Associate Director, US Regulatory CMC At Bayer we’re visionaries, driven...  ...Associate Director US Regulatory Affairs CMC is responsible for...  ...Note: This position is a Local Hybrid role reporting out of Whippany...  ...interactions on assigned projects; Manage virtual and/or cross... 
    Work at office
    Local area
    2 days per week
    3 days per week

    Bayer

    Whippany, NJ
    1 day ago
  •  ...Senior Manager Regulatory Affairs Advertising and PromotionLocation: Morristown, NJ/Cambridge, MAAs the Senior Manager, Regulatory Affairs Advertising and Promotion within our GRA Advertising and Promo Team, you will be responsible for conducting the independent review... 
    Senior
    Work experience placement

    Sanofi

    Morristown, NJ
    5 days ago
  • $108k - $176k

    Manager, CMC Regulatory Affairs - BiologicsAt Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager, CMC Regulatory Affairs - Biologics to join our CMC Regulatory Affairs team, supporting our... 
    Full time
    Worldwide

    Regeneron Pharmaceuticals

    Basking Ridge, NJ
    4 days ago
  • IPolarity LLC in New Jersey is seeking an experienced SAP Test Lead for a contract role in New Brunswick (Hybrid). You will drive test strategy, oversee SIT and UAT, and ensure quality across SAP S/4HANA projects. Must have 12-15+ years SAP testing, strong FICO expertise... 
    Senior
    Remote job
    Contract work

    iPolarity

    Whippany, NJ
    1 day ago
  •  ..., U.S. Ethics & Compliance Advisor, Medical Affairs, to anchor ethics/compliance across US Medical Affairs activities. This hybrid role reports into the ED, US Ethics & Compliance...  ...compliant practices. The role requires senior-level experience in regulated industries, with... 
    Senior

    Gilead Sciences Inc.

    Parsippany, NJ
    2 days ago
  •  ...AbbVie in Florham Park, NJ seeks an Associate Director of Regulatory Affairs Advertising & Promotion - Oncology to lead cross-functional teams...  ...guide multinational initiatives. The position features a hybrid schedule (3 days in office, 2 remote) with opportunities to influence... 
    Senior
    Work at office
    Remote work

    AbbVie

    Florham Park, NJ
    3 days ago
  •  ...collaborate with a top-tier real estate-focused legal team. You will work with families offices, institutions, lenders, and private real estate investors on a wide variety of matters. The role supports a hybrid work environment and ongoing practice growth. #J-18808-Ljbffr
    Senior

    Considine Search

    Livingston, NJ
    4 days ago
  •  ...Bankruptcy and Corporate Restructuring practice in the New York, NY or Livingston, NJ area. This role offers hybrid and remote working opportunities and a platform to manage a portable book of business. The firm provides comprehensive legal counsel on bankruptcy matters,... 
    Senior
    Remote work

    Considine Search

    Livingston, NJ
    3 days ago
  •  ...Industries, Inc. is seeking a Water Resources Project Manager in Parsippany, NJ. This hybrid role focuses on full lifecycle management of water and...  ...construction, with collaboration across design teams and regulatory sites. You will own scope, schedule, and budget, coordinate... 
    Senior

    KLA Industries

    Parsippany, NJ
    8 hours ago
  •  ...Senior Manager position overseeing US advertising and promotion regulatory compliance at AbbVie. Manages regulatory staff, monitors policy...  ...office locations with hybrid scheduling. Responsibilities...  ...5-7 years relevant regulatory affairs experience Demonstrated experience... 
    Senior
    Work at office

    AbbVie

    Florham Park, NJ
    a month ago
  •  ...Piper Companies seeks a Senior Product Manager to support brand strategy and execution for a global pharmaceutical organization within Oncology. This hybrid role is based in Nutley, NJ, with 3 days onsite and strong collaboration across marketing, finance, and external... 
    Senior

    Piper Companies

    Nutley, NJ
    3 days ago
  • $240k

     ...SEC external reporting and oversee SOX/internal controls. The role reports to the VP, Global Controller and is hybrid (3 days on site per week). You will manage the SEC reporting calendar, coordinate audits, and guide technical accounting for complex transactions while... 
    Senior
    3 days per week

    GSP International

    Whippany, NJ
    2 days ago
  •  ...Coaction Global, Inc. is seeking a Senior Claims Examiner in Morristown, NJ, to manage first and third-party Ocean Marine and Energy claims in a hybrid work model. The role requires strong claims handling skills and the ability to coordinate investigations, reserves... 
    Senior

    Coaction Global, Inc.

    Convent Station, NJ
    2 days ago
  • Accenture seeks a Sales Capture Senior Manager to lead end-to-end PVT AI deal shaping and sales pursuit for strategic client opportunities....  ...maintain governance, and drive value-based propositions in a hybrid U.S. environment. Strong leadership and negotiation skills are... 
    Senior

    Accenture

    Convent Station, NJ
    1 day ago
  • $127.28k - $190.92k

     ...SummaryThe purpose of the Project Manager (RACMC) function is to lead...  ...with technical and regulatory standards. This role involves...  ...manager.Coordinate biologics CMC change control activities and...  ...of experience in regulatory affairs required Project Management knowledge... 

    Daiichi Sankyo

    Basking Ridge, NJ
    3 days ago
  •  ...Shionogi Inc. (U.S.) is seeking a Senior Manager/Associate Director, Regulatory Affairs CMC to define and execute global CMC regulatory strategies for investigational and/or marketed assets. The role partners with technical, quality, supply and program teams to deliver... 
    Senior

    Shionogi Inc.

    Florham Park, NJ
    10 hours ago
  • Beacon Hill is seeking a Senior Benefits & Retirement Administrator for a temporary assignment in Hanover, New Jersey. Start date is early...  ...with the assignment through about May 14, and the role offers a hybrid schedule in Whippany, NJ. The position involves supporting... 
    Senior
    Temporary work

    Beacon Hill

    Whippany, NJ
    2 days ago
  • $155k - $170k

     ...communication skills. Responsibilities include drafting pleadings, conducting legal research, and preparing for depositions. The firm offers a hybrid work model, competitive salary ranging from $155k to $170k, and a comprehensive benefits package including paid time off and 401K... 
    Senior

    Nukk-Freeman & Cerra, PC Employment Attorneys

    Chatham, NJ
    2 days ago
  •  ...account entry, prospecting, and building executive relationships with a team of SMEs to deliver tailored professional services. This hybrid office-based position requires a stable work history, with at least ten years in direct B2B sales and a proven track record of... 
    Senior
    Work at office

    Aspire Talent Solutions

    Convent Station, NJ
    2 days ago
  •  ...mid-market clients across Tax, Assurance, Advisory, and Wealth Management — with a focus on relationships, not transactions. Wiss is actively...  ...any fees related to unsolicited resumes. All unsolicited resumes will become the property of Wiss. #LI-HYBRID #J-18808-Ljbffr... 
    Senior

    Wiss & Company, LLP

    Florham Park, NJ
    3 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Senior Manager, Regulatory Affairs - CMC (Hybrid). Be the first to apply!