Director of Regulatory Strategy

1 month ago

San Diego, United States Cypress HCM Full time

The role involves providing global regulatory oversight and project leadership for assigned development products, reporting directly to the Vice President of Regulatory Affairs. The incumbent will contribute to and execute regulatory strategies to facilitate global product development, oversee regulatory communications with health authorities, and ensure adherence to regional regulations. Close collaboration with the cross-functional Development team, external consultants, and advisors is essential to seamlessly integrate regulatory plans and strategies in alignment with overall corporate objectives.

Responsibilities:

  • Represent the Regulatory Affairs department in multidisciplinary product development teams
  • Develop and execute global regulatory strategies for expedited product development across one or more programs
  • Lead preparation of global product development plans, target product profiles, orphan drug designation applications, and pediatric study plans
  • Research regulatory precedents and emerging trends for development risks and opportunities
  • Oversee the global regulatory lifecycle of assigned investigational products, managing timelines and coordinating submission content
  • Interface with the external Regulatory Operations group for document compilation and e-submission
  • Serve as the primary liaison for communication with regulatory health authorities
  • Lead milestone development meetings and prepare the team for engagements
  • Review and communicate current regulatory requirements for compliance with US and international regulations
  • Contribute to the development and review of standard operating procedures (SOPs)
  • Assist in archival and maintenance of regulatory application submissions
  • Monitor the company's progress in meeting regulatory commitments

Requirements:

  • Bachelor’s degree in life sciences; advanced degree preferred; Regulatory Affairs Certification a plus
  • Strong pharmaceutical Regulatory Affairs experience with a focus on drug/biologics development
  • Direct experience in preparing, submitting, and managing global investigational/marketing applications in eCTD format
  • Experience negotiating and interfacing with US and international regulatory authorities
  • Product development experience in dermatology, immunology, or inflammation is a plus
  • In-depth knowledge of GXP/ICH guidelines and global regulations
  • Ability to interpret and apply complex regulatory guidance
  • Strong written and verbal communication, analytical, organizational, and interpersonal skills
  • Excellent strategic planning and cross-functional project management skills
  • Ability to thrive in a dynamic environment with flexibility


Compensation:

· $165-225K

  • Director of Regulatory Strategy

    3 weeks ago

    San Diego, United States Cypress HCM Full time

    The role involves providing global regulatory oversight and project leadership for assigned development products, reporting directly to the Vice President of Regulatory Affairs. The incumbent will contribute to and execute regulatory strategies to facilitate global product development, oversee regulatory communications with health authorities, and ensure...

  • Director of Regulatory Strategy

    1 month ago

    San Diego, United States Cypress HCM Full time

    The role involves providing global regulatory oversight and project leadership for assigned development products, reporting directly to the Vice President of Regulatory Affairs. The incumbent will contribute to and execute regulatory strategies to facilitate global product development, oversee regulatory communications with health authorities, and ensure...

  • Director of Regulatory Strategy

    1 month ago

    San Diego, United States Cypress HCM Full time

    The role involves providing global regulatory oversight and project leadership for assigned development products, reporting directly to the Vice President of Regulatory Affairs. The incumbent will contribute to and execute regulatory strategies to facilitate global product development, oversee regulatory communications with health authorities, and ensure...

  • Sr. Dir/Director of Regulatory CMC

    3 weeks ago

    San Diego, United States BioPhase Full time

    Remote - Candidates must be located in the United States - Ideally Southern California The Sr. Director/Director of CMC Regulatory Affairs will be responsible for developing, leading and executing CMC regulatory strategies and activities for the organization, including the preparation and filing of BLA submissions. This position is a hands-on role, providing...

  • Executive Director, Regulatory Affairs

    7 days 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 Executive Director in Regulatory Affairs to oversee and direct the strategic planning and execution of clinical regulatory activities essential for...

  • Executive Director, Regulatory Affairs

    5 days 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 Executive Director in Regulatory Affairs to oversee and direct the strategic planning and execution of clinical regulatory activities essential for...

  • Executive 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 Executive Director in Regulatory Affairs to oversee and direct the strategic planning and execution of clinical regulatory activities essential for...

  • Executive Director, Regulatory Affairs

    1 month 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 Executive Director in Regulatory Affairs to oversee and direct the strategic planning and execution of clinical regulatory activities essential for...

  • Regulatory Affairs Director

    4 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 &...

  • Regulatory Strategy Consultant

    1 week ago

    San Rafael, United States Katalyst Healthcares and Life Sciences Full time

    Responsibilities: Provide strategic insight to the GRT regarding product development, and serve as Regulatory contributor to partner teams (eg, study execution teams, clinical development team etc.) as appropriate In collaboration with regional regulatory representatives, ensure that feedback from global Health Authorities is incorporated into the...

  • Sr. Director Regulatory Affairs

    1 month ago

    South San Francisco, United States Life Science People Full time

    Senior Director of Regulatory AffairsMenlo Park, CA Life Science People are currently working with an exciting client, looking for a Sr. Director Regulatory Affairs professional with a strong background in oncology submissions. My client is looking for someone to come in and lead their regulatory efforts in oncology as they pioneer cortisol modulation...

  • Senior Director Regulatory Affairs

    2 days ago

    San Francisco, United States SciPro Full time

    Senior Director, Regulatory AffairsSan Francisco, CA (Hybrid)Join this Bioscience company on the forefront of groundbreaking therapeutics! I'm supporting a company seeking a dynamic individual for the role of Sr. Director, Regulatory Affairs. This pivotal position offers the opportunity to spearhead regulatory strategies for our expanding CRISPR-based...

  • Senior Director Regulatory Affairs

    4 weeks ago

    San Francisco, United States SciPro Full time

    Senior Director, Regulatory AffairsSan Francisco, CA (Hybrid)Join this Bioscience company on the forefront of groundbreaking therapeutics! I'm supporting a company seeking a dynamic individual for the role of Sr. Director, Regulatory Affairs. This pivotal position offers the opportunity to spearhead regulatory strategies for our expanding CRISPR-based...

  • Director, Regulatory Affairs

    6 days 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...

  • Manager-Director, Regulatory

    4 weeks ago

    San Diego, United States Kumquat Biosciences Inc Full time

    Job DescriptionJob DescriptionDescription:Responsible for providing support in Regulatory Operations filing multiple original INDs each year and managing multiple active INDs in Phase 1/2 clinical trials (US, Canada, EU and APAC). He/she will manage day to day regulatory operations to ensure all Kumquat regulatory submissions are on time, complete, and...

  • Manager-Director, Regulatory

    2 weeks ago

    San Diego, United States Kumquat Biosciences Inc Full time

    Job DescriptionJob DescriptionDescription:Responsible for providing support in Regulatory Operations filing multiple original INDs each year and managing multiple active INDs in Phase 1/2 clinical trials (US, Canada, EU and APAC). He/she will manage day to day regulatory operations to ensure all Kumquat regulatory submissions are on time, complete, and...

  • Director, Regulatory Affairs

    6 days 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, California, 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

    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...

  • Head of Regulatory and Quality

    1 week ago

    San Diego, United States Candid Therapeutics Full time

    **Company Overview**: Candid Therapeutics is a growing biotechnology company based in San Diego, California, dedicated to improving patients’ lives by advancing novel therapies to address unmet medical needs. **Position Overview**: As the Head of Regulatory and Quality, you will be a key member of our executive leadership team, responsible for providing...