Associate Director Regulatory Affairs

3 weeks ago

San Diego, United States Partnology Full time

An exciting and innovative clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer and autoimmune disease is looking for an Associate Director in Regulatory Affairs to oversee and contribute to the strategic planning and execution of clinical regulatory activities essential for initiating and conducting clinical trials and securing marketing authorization. This role involves extensive interaction with regulatory agencies such as the FDA, EMA, and PMDA, seeking scientific advice and approvals, and provides cross-functional leadership for global filings, ensuring compliance with local regulatory requirements and authoring/reviewing submission documents for regulatory applications. The ideal candidate will have experience leading regulatory teams and a successful record of approved regulatory submissions. This is a full-time, exempt position located at our corporate headquarters in San Diego, CA.

Find out more about this role by reading the information below, then apply to be considered.

Responsibilities:

  • Contribute to strategic planning and implementation of clinical regulatory activities required to initiate and conduct clinical trials and to seek marketing authorization.
  • Interact with the FDA, EMA, PMDA, and other regulatory agencies to seek scientific and regulatory advice and obtain required approvals.
  • Provide strong cross-functional leadership for global filings including authoring/reviewing sections of IND/CTA, NDA/BLA/MAA, and other global submission documents in support of clinical trials and marketing applications, as well as their amendments, in conformance with local regulatory requirements.
  • Develop and implement cross-functional department policies, processes, work instructions, and standard operating procedures.
  • Provide regulatory leadership for due diligence activities, partnering activities, and product/company integrations.
  • Support the development and implementation of innovative systems, tools, and streamlined processes to create and maintain high-quality regulatory submissions and manage a state-of-the-art regulatory intelligence and knowledge management approach.
  • Ensure inspection readiness efforts for regulatory activities and files.
  • Participate in preparing regulatory budgets and managing vendors.
  • Maintain current expertise in regulatory trends and operations.
  • Participate as needed in technical discussions and collaborate with corresponding groups at Health Authorities to advance Regulatory Science.

Qualifications:

  • Bachelor of Science with at least eight (8) years of progressive and relevant experience. Master’s degree or PhD preferred.
  • Regulatory experience with clearing INDs and CTAs and gaining approvals of NDAs, MAAs, BLAs and/or sBLAs.
  • Demonstrated proficiencies contributing to successful health authority meetings.
  • Experience with breakthrough, RMAT, and orphan designation submissions; experience with companion diagnostic submissions (IDE/PMA) a plus.
  • Experience with cell and gene therapy products/complex biological products.
  • Experience with autoimmune products and interacting with FDA CBER and EMA; additional experience with oncology products a plus.
  • Experience in leading multidisciplinary teams desired to deliver cross-functional regulatory deliverables.
  • Strong knowledge in clinical and nonclinical regulatory science.
  • Knowledgeable regarding global regulatory submission standards and publishing best practices.
  • Ability and interest in rolling up their sleeves to perform hands-on regulatory activities while simultaneously building the department to ensure successful scalability as the programs grow.
  • Ability to influence without direct authority.

Working Conditions:

  • Travel may be required.
  • Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.

  • Associate Director Regulatory Affairs

    4 weeks ago

    San Diego, United States Partnology Full time

    An exciting and innovative clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer and autoimmune disease is looking for an Associate Director in Regulatory Affairs to oversee and contribute to the strategic planning and execution of clinical regulatory activities essential for...

  • Associate Director Regulatory Affairs

    4 weeks ago

    San Diego, United States Partnology Full time

    An exciting and innovative clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer and autoimmune disease is looking for an Associate Director in Regulatory Affairs to oversee and contribute to the strategic planning and execution of clinical regulatory activities essential for...

  • Associate Director Regulatory Affairs

    4 weeks ago

    San Diego, United States Partnology Full time

    An exciting and innovative clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer and autoimmune disease is looking for an Associate Director in Regulatory Affairs to oversee and contribute to the strategic planning and execution of clinical regulatory activities essential for...

  • Associate Director Regulatory Affairs

    1 week ago

    San Diego, United States Partnology Full time

    An exciting and innovative clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer and autoimmune disease is looking for an Associate Director in Regulatory Affairs to oversee and contribute to the strategic planning and execution of clinical regulatory activities essential for...

  • Associate Director Regulatory Affairs

    2 weeks ago

    San Diego, United States Partnology Full time

    An exciting and innovative clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer and autoimmune disease is looking for an Associate Director in Regulatory Affairs to oversee and contribute to the strategic planning and execution of clinical regulatory activities essential for...

  • Associate Director, Regulatory Affairs

    5 days ago

    South San Francisco, United States Cytokinetics Full time

    Reporting to the Senior Director, Regulatory Affairs, the Associate Director of Regulatory Affairs leads regulatory support for assigned programs to ensure sound regulatory planning and tactical implementation of US and international development strategies. **Responsibilities** - Formulate regulatory strategies, with supervisor oversight, based on current...

  • Regulatory Affairs Associate

    2 weeks ago

    South San Francisco, United States Cytokinetics Full time

    Reporting to the Senior Director of Regulatory Affairs, the Regulatory Affairs Associate is responsible for coordination and preparation of a variety of regulatory submissions and for assisting the Regulatory Affairs team with various projects. **Responsibilities** - Prepare and/or coordinate and comply routine regulatory submissions and other...

  • Regulatory Affairs Director

    2 months ago

    San Francisco, United States BioLink 360 Full time

    Company Location: Bay Area Comp: 150K-220K Position Reports to: VP of Regulatory and Quality Director of Regulatory Affairs -San Francisco We are seeking a highly motivated and experienced Senior Director of Regulatory Affairs for a Medical Device Orthopedic Portfolio. This person will lead interactions with regulatory agencies globally and help develop &...

  • Regulatory Affairs Director

    2 weeks ago

    San Francisco, United States BioLink 360 Full time

    Company Location: Bay Area Comp: 150K-220K Position Reports to: VP of Regulatory and Quality Director of Regulatory Affairs -San Francisco We are seeking a highly motivated and experienced Senior Director of Regulatory Affairs for a Medical Device Orthopedic Portfolio. This person will lead interactions with regulatory agencies globally and help develop &...

  • Associate Director, Regulatory Affairs Cmc

    1 week ago

    South San Francisco, United States ALX Oncology Inc. Full time

    We are looking for an** Associate Director/Director, Regulatory Affairs CMC **to join our team. **Responsibilities**: These include but are not limited to: - Providing dynamic regulatory leadership to project teams and working collaboratively with cross-functional team members and external contractors/vendors/consultants to identify optimum and workable...

  • Head of Regulatory Affairs

    4 days ago

    San Diego, United States KayeBassman Full time

    Position Title: Head of Regulatory Affairs Location: Southern California Company Overview: We are partnered with a cutting-edge pre-IPO cell therapy company dedicated to transforming the lives of patients with cancer and autoimmune diseases. There innovative pipeline harnesses the power of cellular therapies to provide groundbreaking treatment options. As...

  • Director, Regulatory Affairs

    1 month ago

    South San Francisco, United States Maze Therapeutics Full time

    The Position: Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global Program Lead, you will...

  • Director, Regulatory Affairs

    2 weeks ago

    South San Francisco, United States Maze Therapeutics Full time

    The Position: Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global Program Lead, you will...

  • Head of Regulatory Affairs

    2 weeks ago

    San Diego, United States KayeBassman International Full time

    Position Title: Head of Regulatory AffairsLocation: Southern CaliforniaCompany Overview: We are partnered with a cutting-edge pre-IPO cell therapy company dedicated to transforming the lives of patients with cancer and autoimmune diseases. There innovative pipeline harnesses the power of cellular therapies to provide groundbreaking treatment options. As they...

  • Head of Regulatory Affairs

    2 weeks ago

    San Diego, United States KayeBassman International Full time

    Position Title: Head of Regulatory AffairsLocation: Southern CaliforniaCompany Overview: We are partnered with a cutting-edge pre-IPO cell therapy company dedicated to transforming the lives of patients with cancer and autoimmune diseases. There innovative pipeline harnesses the power of cellular therapies to provide groundbreaking treatment options. As they...

  • Head of Regulatory Affairs

    1 week ago

    San Diego, United States KayeBassman International Full time

    Position Title: Head of Regulatory AffairsLocation: Southern CaliforniaCompany Overview: We are partnered with a cutting-edge pre-IPO cell therapy company dedicated to transforming the lives of patients with cancer and autoimmune diseases. There innovative pipeline harnesses the power of cellular therapies to provide groundbreaking treatment options. As they...

  • Head of Regulatory Affairs

    1 week ago

    San Diego, United States KayeBassman International Full time

    Position Title: Head of Regulatory AffairsLocation: Southern CaliforniaCompany Overview: We are partnered with a cutting-edge pre-IPO cell therapy company dedicated to transforming the lives of patients with cancer and autoimmune diseases. There innovative pipeline harnesses the power of cellular therapies to provide groundbreaking treatment options. As they...

  • Director, Regulatory Affairs

    1 month ago

    South San Francisco, United States Maze Therapeutics Full time

    Job DescriptionJob DescriptionThe Position:Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global...

  • Director, Regulatory Affairs

    1 month ago

    South San Francisco, United States Maze Therapeutics Full time

    Job DescriptionJob DescriptionThe Position:Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global...

  • Director, Regulatory Affairs

    1 week ago

    South San Francisco, United States Maze Therapeutics Full time

    Job DescriptionJob DescriptionThe Position:Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global...