Jobs
>
New York City

    Director of Regulatory Affairs Strategy - New Jersey, United States - Meet

    Meet
    Meet New Jersey, United States

    Found in: Appcast US C2 - 6 days ago

    Default job background
    Description

    We are partnering with an exciting oncology biotech that is looking for an accomplished Director of Regulatory Affairs Strategy to lead within their Regulatory Affairs team. The ideal candidate will be responsible for developing and executing regulatory strategies that drive the successful development, registration, and commercialization of products in their Oncology portfolio.

    Responsibilities:

    • Develop and implement comprehensive regulatory strategies aligned with business objectives and regulatory requirements to support product development and commercialization.
    • Provide strategic leadership and guidance on regulatory matters to cross-functional teams, including R&D, Clinical Development, Quality Assurance, and Commercial teams, throughout the product lifecycle.
    • Lead regulatory interactions and negotiations with health authorities, including preparation and submission of regulatory filings, meeting packages, and responses to regulatory queries.
    • Stay abreast of evolving regulatory landscape and proactively assess potential impacts on product development and commercialization strategies.
    • Drive continuous improvement initiatives to enhance regulatory processes, systems, and capabilities, ensuring compliance with applicable regulations and guidelines.
    • Mentor and develop regulatory affairs team members, fostering a culture of excellence, innovation, and professional growth.

    Qualifications:

    • Bachelor's degree in life sciences or related field required; advanced degree (e.g., Master's, PhD, PharmD) preferred.
    • Minimum of 8 years of progressive experience in regulatory affairs and a minimum of 10 years in the pharmaceutical or biotechnology industry.
    • at least 5 years of regulatory in Oncology required
    • Expert knowledge of global regulatory requirements and guidelines for drug development and commercialization, including FDA, EMA, and other major regulatory agencies.
    • Proven track record of successfully leading regulatory activities for pharmaceutical products across multiple therapeutic areas and geographic regions.
    • Exceptional leadership, communication, and influencing skills, with the ability to collaborate effectively with internal and external stakeholders at all levels.
  • SciPro

    Director, Regulatory Affairs Strategy

    Found in: Appcast Linkedin GBL C2 - 1 day ago

    SciPro New Jersey, United States

    Our client, a Reputable, Global Pharmaceutical Company, is seeking a Regulatory Affairs Strategy professional at the Director level. This role will advise, develop and implement regulatory strategies for specific assets within Oncology. The position will report directly into the ...

  • Attaineo Search, Inc.

    Director, Regulatory Affairs Strategy

    Found in: Lensa US 4 C2 - 1 day ago

    Attaineo Search, Inc. New York, United States

    Job Description · Position: Director, Regulatory Affairs Strategy · Location: New York City, NY (Remote) · Overview: · The Director of Regulatory Affairs Strategy will take a lead role in crafting and executing global and regional regulatory strategies for a range of projects ...

  • NS Pharma, Inc.

    Director, Regulatory Affairs Strategy

    Found in: Appcast US C2 - 5 days ago

    NS Pharma, Inc. Paramus, United States

    Responsible for developing and implementing short and long term global regulatory strategies that support the success of investigational and marketed pharmaceutical products throughout their life cycle. The Director will manage and lead regulatory strategy and submission related ...

  • NS Pharma Inc

    Director, Regulatory Affairs Strategy

    Found in: Lensa US 4 C2 - 3 days ago

    NS Pharma Inc Paramus, United States

    Responsible for developing and implementing short and long term global regulatory strategies that support the success of investigational and marketed pharmaceutical products throughout their life cycle. The Director will manage and lead regulatory strategy and submission related ...

  • NS Pharma Inc

    Director, Regulatory Affairs Strategy

    Found in: Lensa US 4 C2 - 4 days ago

    NS Pharma Inc Paramus, United States

    Responsible for developing and implementing short and long term global regulatory strategies that support the success of investigational and marketed pharmaceutical products throughout their life cycle. The Director will manage and lead regulatory strategy and submission related ...

  • Daiichi Sankyo

    Director, US Regulatory Affairs Strategy

    Found in: Jooble US O C2 - 1 day ago

    Daiichi Sankyo Basking Ridge, United States Full time

    Join a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class scie ...

  • Regeneron Pharmaceuticals, Inc

    Director, Regulatory Affairs Strategy, Hematology

    Found in: Talent US C2 - 5 days ago

    Regeneron Pharmaceuticals, Inc Bernards, United States Full time

    The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so res ...

  • Ferring Pharmaceuticals Inc.

    Senior Manager, Regulatory Affairs Therapeutic Area Strategy

    Found in: Lensa US 4 C2 - 4 days ago

    Ferring Pharmaceuticals Inc. Parsippany, United States

    As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that Regulatory Affairs, Strategy, ...

  • Ferring Pharmaceuticals Inc.

    Associate Director, Regulatory Affairs Therapeutic Area Strategy

    Found in: Lensa US 4 C2 - 4 days ago

    Ferring Pharmaceuticals Inc. Parsippany, United States

    As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that Regulatory Affairs, Director, ...

  • ACE Partners

    Senior Regulatory Affairs Specialist

    Found in: Appcast US C2 - 4 days ago

    ACE Partners New York, United States

    Our customer is looking for a Senior Regulatory Affairs Specialist to join a team of 7 and supporting the product submissions, regulatory guidance, and registering products. · Duties Include: · Maintain and establish regulatory functions for medical device and environmental comp ...

  • Leaman Life Sciences

    Medical Affairs Director Neurodegeneration

    Found in: Appcast US C2 - 1 day ago

    Leaman Life Sciences New Jersey, United States

    This is a new exciting opportunity to work for a global pharmaceutical company that is making significant progress and changes for patients worldwide who suffer from diseases related to Neurology. · This role is for a Medical Director, a strategic role where you have control and ...

  • Grnwestpalmbeach

    Driven Vice President, Regulatory Affairs

    Found in: Lensa US 4 C2 - 2 days ago

    Grnwestpalmbeach New York, United States

    ** Driven Vice President, Regulatory Affairs & Quality Assurance-NYNY** · **Required Experience:** · Leads/participates in development and execution of regulatory strategy · Interacts with regulatory agencies · **Required Education:** · BA/BS (or equivalent) in pharmacy, che ...

  • Daiichi Sankyo, Inc.

    Director, Medical Development, Oncology

    Found in: One Red Cent US C2 - 18 hours ago

    Daiichi Sankyo, Inc. New Jersey, United States

    Join a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class scie ...

  • Hanson Search

    Senior Account Manager, Corporate Communications

    Found in: Appcast Linkedin GBL C2 - 5 days ago

    Hanson Search New York, United States

    I am seeking a dynamic and experienced Senior Account Manager, Corporate Communications to join the New York office of a Global Corporate Communications and Public Affairs Agency. My client specializes in strategic corporate communications, public affairs, with an international p ...

  • Daiichi Sankyo, Inc.

    Director, Medical Office

    Found in: One Red Cent US C2 - 18 hours ago

    Daiichi Sankyo, Inc. New Jersey, United States

    Join a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class scie ...

  • Daiichi Sankyo, Inc.

    Associate Director, GMA Oncology

    Found in: One Red Cent US C2 - 18 hours ago

    Daiichi Sankyo, Inc. New Jersey, United States

    Join a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class scie ...

  • ForceBrands

    Regulatory Manager

    Found in: Appcast US C2 - 3 days ago

    ForceBrands New York, United States

    **THIS IS NOT A ROLE WITH FORCEBRANDS** · This position requires being on-site in SoHo every Tuesday, Wednesday, and Thursday. · Responsibilities: · Regulatory Compliance: Ensure compliance with local, national, and international regulations and standards, while developing and ex ...

  • Daiichi Sankyo, Inc.

    Director Managed Care Medical

    Found in: One Red Cent US C2 - 12 hours ago

    Daiichi Sankyo, Inc. New Jersey, United States

    Join a Legacy of Innovation 110 Years and Counting Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class scienc ...

  • BioTalent

    Director, Regulatory Affairs, Advertising and Promotion

    Found in: Lensa US 4 C2 - 4 days ago

    BioTalent New York, United States

    Director, Regulatory Affairs, Advertising and Promotion (Ad/Promo) · Remote · – United States · Seeking a Director of Regulatory Affairs for Advertising and Promotion to lead commercial regulatory strategy and leadership for the US business for a commercialized biopharmaceutical ...

  • Columbia University

    Senior Director of Student Affairs

    Found in: One Red Cent US C2 - 6 hours ago

    Columbia University New York, United States

    Job Type: Officer of Administration · Bargaining Unit: · Regular/Temporary: Regular · End Date if Temporary: · Hours Per Week: 35 · Standard Work Schedule: · Building: · Salary Range: $110,000-$130,000 · The salary of the finalist selected for this role will be set based on a var ...