Senior Vice President of Regulatory Affairs

2 weeks ago

San Diego, California, United States Radionetics Oncology, Inc. Full time
Position Overview

About Radionetics Oncology
Radionetics Oncology, Inc. is a pioneering clinical-stage organization dedicated to the innovation and advancement of cutting-edge radiopharmaceuticals aimed at treating a diverse array of oncology conditions. The company is strategically positioned to leverage the growing demand for novel radiotherapeutics and is backed by esteemed investors including Frazier Life Sciences, 5AM Ventures, DCVC Bio, Crinetics Pharmaceuticals, and GordonMD Global Investments. Radionetics is actively progressing a pipeline of first-in-class small molecule radioligands that target G protein-coupled receptors for the treatment of various cancers, such as breast and lung cancer, among others that exhibit significant unmet medical needs.

Role Summary
The Senior Vice President / Vice President of Regulatory Affairs serves as the primary leader for all regulatory initiatives within the organization. This executive is the main liaison for regulatory bodies and is responsible for all tactical regulatory activities. The individual will skillfully develop and articulate the regulatory strategy to ensure alignment with the company’s business goals. A wealth of experience in engaging with regulatory agencies, particularly the FDA, is essential, along with a proven track record of guiding organizations through successful FDA approvals, including NDAs and INDs. The VP/SVP must be highly driven, purpose-oriented, and capable of effectively leading and collaborating with cross-functional teams.

Key Responsibilities

  • Oversee all tactical and strategic regulatory affairs deliverables for the organization, including drafting and managing all regulatory submissions for each development initiative, ensuring timely execution while adhering to budgetary constraints.
  • Act as the primary contact for all regulatory authorities, including the FDA and other relevant agencies.
  • Evaluate data and the regulatory landscape to align business objectives with regulatory priorities.
  • Formulate and implement regulatory risk management strategies and contingency plans.
  • Represent the organization in regulatory discussions with both internal and external stakeholders, including board members and partners.
  • Provide training and guidance on FDA and other regulatory requirements to internal teams.
  • Contribute to senior leadership discussions, offering regulatory insights and guidance on broader corporate matters.
  • Lead, mentor, and assess direct and indirect reports, ensuring accountability in decision-making processes.
  • Collaborate with cross-functional teams on regulatory activities and submissions, fostering a cooperative environment.
  • Stay informed on regulatory requirements and best practices.
  • Fulfill additional responsibilities as required by business needs.

Qualifications

  • Ph.D., Pharm.D., or equivalent advanced degree in a scientific discipline.
  • A minimum of 15 years of relevant experience in regulatory affairs or related functions within drug development, demonstrating progressive leadership within the pharmaceutical or biotechnology sectors. At least 5 years in a regulatory leadership capacity is essential.
  • Extensive hands-on experience in leading nonclinical, clinical, and CMC strategy and documentation, with a successful history in global regulatory affairs.
  • In-depth knowledge of FDA and EMA regulations, international clinical trial regulations, and ICH GCP, GMP, GLP guidelines.
  • Exceptional interpersonal, organizational, and communication skills, both verbal and written.
  • Proven problem-solving abilities and the capacity to work independently as well as collaboratively.
  • Strong proficiency in computer skills and Microsoft 365 applications.

Work Environment
This position allows for a hybrid work model, with some responsibilities potentially performed remotely.

Compensation & Benefits
Radionetics offers a competitive compensation package that includes performance bonuses, equity options, comprehensive medical, dental, and vision insurance, life insurance, short-term and long-term disability coverage, a 401(k) retirement plan, four weeks of paid time off annually, and generous holiday benefits.

Pay Range: $290,000 - $350,000
Compensation decisions are based on various factors, including education, experience, skills, internal equity, role complexity, and market demand.

Equal Opportunity Employment
Radionetics Oncology, Inc. is committed to equal opportunity employment, ensuring that all qualified applicants receive fair consideration without regard to race, color, national origin, ancestry, religion, sex, pregnancy, marital status, sexual orientation, gender identity, age, disability, medical condition, genetic information, military status, or any other protected class.

The information provided in this job description is intended to outline the general nature and level of work performed by individuals in this role. It is not intended to be an exhaustive list of all responsibilities and requirements. Radionetics reserves the right to modify duties, education, experience, skills, or other job requirements at any time.

  • Senior Vice President of Regulatory Affairs

    7 days ago

    San Diego, California, United States Radionetics Oncology, Inc. Full time

    Job OverviewAbout Radionetics OncologyRadionetics Oncology, Inc. is a pioneering clinical-stage organization dedicated to the innovation and advancement of cutting-edge radiopharmaceuticals aimed at treating a diverse array of oncology conditions. The company is strategically positioned to leverage the growing demand for novel radiotherapeutics and is backed...

  • Senior Vice President of Regulatory Affairs

    7 days ago

    San Diego, California, United States Radionetics Oncology, Inc. Full time

    Position OverviewAbout Radionetics OncologyRadionetics Oncology, Inc. is a pioneering clinical-stage organization dedicated to the innovation and advancement of cutting-edge radiopharmaceuticals aimed at treating a diverse array of oncology conditions. The company is strategically positioned to leverage the growing demand for novel radiotherapeutics,...

  • Vice President of Regulatory Affairs

    7 days ago

    San Diego, California, United States Travere Therapeutics Full time

    Position Overview: Executive Director, Regulatory AffairsDepartment: RegulatoryLocation: San DiegoJoin a dedicated global team committed to improving the lives of individuals affected by rare diseases.At Travere Therapeutics, we understand that our remarkable team members are essential to our achievements. We are focused on addressing the distinct needs of...

  • Regulatory Affairs Senior Manager

    1 week ago

    San Diego, California, United States Contineum Therapeutics Full time

    Position Overview:Reporting directly to the Senior Vice President of Regulatory Affairs, the Senior Manager or Associate Director of Regulatory Affairs will spearhead and engage in regulatory initiatives related to IND/CTA preparations and ongoing maintenance to facilitate both new and existing development programs. This position demands a proactive,...

  • Regulatory Affairs Senior Manager

    2 weeks ago

    San Diego, California, United States Contineum Therapeutics Full time

    Position Overview:Reporting to the Senior Vice President of Regulatory Affairs, the Regulatory Affairs Senior Manager or Associate Director will spearhead and engage in regulatory initiatives related to IND/CTA preparation and ongoing maintenance to facilitate both new and existing development programs. This position necessitates a proactive,...

  • Vice President of Regulatory Affairs

    7 days ago

    San Diego, California, United States Travere Therapeutics Full time

    Director of Global Regulatory AffairsDepartment: RegulatoryLocation: San DiegoJoin a dedicated team committed to improving the lives of individuals affected by rare diseases.At Travere Therapeutics, we understand that our remarkable employees are crucial to our achievements. We are a passionate team focused on addressing the distinct needs of patients with...

  • Regulatory Affairs Leader

    1 week ago

    San Diego, California, United States Radionetics Oncology Full time

    About Radionetics OncologyRadionetics Oncology is a clinical-stage biotechnology company dedicated to the discovery and development of innovative radiopharmaceuticals for the treatment of various oncology indications. With a strong focus on novel radiotherapeutics, the company is poised to capitalize on the growing demand for effective cancer...

  • Senior Vice President of Legal Affairs

    2 weeks ago

    San Mateo, California, United States Visa Full time

    Position OverviewThe Senior Vice President of Legal Affairs at Visa will play a pivotal role in guiding our corporate strategy through comprehensive legal oversight. This position is integral to our ongoing transformation within the Corporate IT sector.Key ResponsibilitiesLead the legal department in providing strategic advice and support to various business...

  • Senior Vice President of Regulatory Strategy

    7 days ago

    San Diego, California, United States Travere Therapeutics Full time

    Director of Global Regulatory AffairsDepartment: RegulatoryLocation: San DiegoJoin a dedicated team committed to transforming the lives of individuals affected by rare diseases.At Travere Therapeutics, we understand that our remarkable workforce is crucial to our achievements. We are a passionate group focused on addressing the distinct needs of patients...

  • Executive Vice President of Regulatory Affairs

    2 weeks ago

    San Francisco, California, United States 5H0 Hub International Limited Full time

    About 5H0 Hub International Limited:5H0 Hub International Limited is a leading provider of insurance brokerage services, dedicated to equipping businesses and individuals with the necessary tools to navigate uncertainties. Our extensive network of professionals is committed to delivering customized insurance solutions that ensure peace of mind.About Our...

  • Senior Vice President, Medical Affairs

    2 days ago

    South San Francisco, California, United States TBWA\Chiat\Day Full time

    Job SummaryWe are seeking a highly experienced and skilled Senior Vice President, Medical Affairs to lead our medical strategy and scientific communications efforts. This is a critical role that will require a deep understanding of the biopharmaceutical industry, medical affairs, and scientific communications.Key ResponsibilitiesDevelop and execute a...

  • Executive Vice President, Head of Medical Affairs

    2 weeks ago

    San Diego, California, United States Halozyme Full time

    Position OverviewAs the Executive Vice President, Head of Medical Affairs, you will play a pivotal role in shaping the medical strategy for our organization. This leadership position is essential for guiding our initiatives in Subcutaneous Drug Development, Regulatory Affairs, and Drug Safety.About HalozymeAt Halozyme, we are dedicated to transforming the...

  • Vice President of Scientific Affairs

    2 weeks ago

    San Diego, California, United States PharmaScouts Inc Full time

    We present a unique opportunity for a Vice President of Scientific Affairs who is passionate about influencing drug development methodologies and regulatory approvals. Our organization collaborates with consortia that include industry specialists, healthcare professionals, patient advocacy groups, and regulatory authorities, all committed to accelerating the...

  • Executive Director, Regulatory Affairs Strategist

    1 day ago

    San Diego, California, United States Travere Therapeutics Full time

    Job SummaryWe are seeking a highly experienced and skilled Executive Director, Regulatory Affairs to join our team at Travere Therapeutics. As a key member of our Regulatory Affairs department, you will be responsible for developing and executing global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease.Key...

  • Head of Regulatory Affairs

    7 days ago

    San Diego, California, United States Travere Therapeutics Full time

    Director of Global Regulatory AffairsDepartment: RegulatoryLocation: San DiegoJoin a global team dedicated to transforming the lives of individuals affected by rare diseases.At Travere Therapeutics, we understand that our outstanding workforce is crucial to our achievements. We are a committed group focused on addressing the specific needs of patients with...

  • Vice President of Regulatory Affairs

    2 weeks ago

    San Mateo, California, United States Gilead Sciences Full time

    About the Role Gilead Sciences is seeking a dynamic and experienced professional to lead our Regulatory Affairs Business Operations. This role is pivotal in ensuring that our talented workforce operates in an environment that fosters excellence and innovation. Key Responsibilities Oversee the strategic direction of Regulatory Affairs, ensuring...

  • Senior Vice President of Quality Management

    2 weeks ago

    South San Francisco, California, United States Hibio Full time

    POSITION TITLE:Senior Vice President of Quality ManagementDIVISION:Regulatory AffairsEMPLOYMENT TYPE:Full-TimeHI-Bio, Inc. is a pioneering biotechnology firm located in South San Francisco, California. Our collective mission is to revolutionize the treatment of patients suffering from severe immune-mediated disorders by creating innovative targeted therapies...

  • Chief Regulatory Affairs Officer

    7 days ago

    San Diego, California, United States Travere Therapeutics Full time

    Director of Global Regulatory AffairsDepartment: RegulatoryLocation: San DiegoJoin a dedicated team committed to improving the lives of individuals affected by rare diseases.At Travere Therapeutics, we value our outstanding employees as the cornerstone of our achievements. Our team is passionately focused on addressing the distinct needs of patients with...

  • Senior Vice President of Operations

    2 weeks ago

    San Diego, California, United States Helix Electric Full time

    Position Overview:The Senior Vice President of Operations is tasked with driving sustainable growth through the effective management of the initiation, development, and execution of new Commercial & Industrial (C&I), energy generation, and energy storage initiatives.Key Responsibilities:The Senior Vice President will oversee all operational functions,...

  • Senior Vice President of Quality Assurance

    5 days ago

    South San Francisco, California, United States Annexon Bioscience Full time

    Job SummaryWe are seeking a highly experienced and skilled Senior Vice President of Quality Assurance to join our team at Annexon Biosciences. As a key member of our leadership team, you will be responsible for overseeing and implementing our quality management systems, ensuring compliance with regulatory requirements, and driving continuous improvement...