Current jobs related to Senior Vice President of Regulatory Affairs - San Diego, California - Radionetics Oncology, Inc.
-
Vice President Regulatory Affairs Lead
4 weeks ago
San Diego, California, United States Trebla Talent Full timeJob Title: Vice President Regulatory AffairsCompany: Trebla TalentLocation: San Diego - HybridJob Type: Full-timeAbout the CompanyTrebla Talent is a pioneering cell therapy biotech focused on developing innovative immunotherapies for cancer treatment. With a strong 2024 performance following their IPO and announcement of their autoimmune portfolio, they've...
-
Senior Vice President of Regulatory Affairs
1 week ago
San Mateo, California, United States Aerogen Full timeAbout Aerogen PharmaAerogen Pharma is a US-based clinical-stage specialty pharmaceutical company dedicated to developing innovative inhaled drug and biologic combination products that transform the standard of care for acute and critically ill patients.Our mission is to create medically superior, proprietary, and commercially differentiated combination...
-
Vice President of Regulatory Affairs
7 days ago
South San Francisco, California, United States insitro Full timeAbout the RoleWe are seeking a highly skilled Vice President of Regulatory Affairs to join our team at insitro. As a key member of our leadership team, you will be responsible for developing and implementing global regulatory strategies to support the development of multiple therapeutics and diagnostics.Key ResponsibilitiesBuild and lead the entire...
-
San Mateo, California, United States Aerogen Full timeAbout Aerogen PharmaAerogen Pharma is a clinical-stage specialty pharmaceutical company dedicated to developing innovative inhaled drug and biologic combination products that transform the standard of care for acute and critically ill patients.Our mission is to create medically superior, proprietary, and commercially differentiated combination products by...
-
San Francisco, California, United States KMR Search Group Full timeJob SummaryThe Vice President of Regulatory Affairs & Quality Assurance is responsible for directing the Company's global regulatory and quality assurance strategies. This individual establishes the organization's goals and objectives regarding regulatory affairs and quality assurance and ensures they are achieved.Key ResponsibilitiesManages the preparation...
-
Executive Vice President of Regulatory Affairs
2 months ago
San Francisco, California, United States 5H0 Hub International Limited Full timeAbout 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...
-
San Mateo, California, United States Aerogen Full timeAbout AerogenAerogen is a US-based clinical-stage specialty pharmaceutical company dedicated to developing innovative inhaled drug and biologic combination products that transform the standard of care for acute and critically ill patients.Our mission is to create medically superior, proprietary, and commercially differentiated combination products by...
-
San Mateo, California, United States Aerogen Full timeAbout Aerogen PharmaAerogen Pharma is a clinical-stage specialty pharmaceutical company dedicated to developing innovative inhaled drug and biologic combination products that transform the standard of care for acute and critically ill patients.Our mission is to create medically superior, proprietary, and commercially differentiated combination products by...
-
San Francisco, California, United States KMR Search Group Full timeJob SummaryThe Vice President of Regulatory Affairs & Quality Assurance is responsible for directing the Company's global regulatory and quality assurance strategies. This individual is responsible for leading all submissions and communications with regulatory authorities and managing international submissions and responses. Additionally, this individual...
-
Regulatory Affairs Vice President
2 weeks ago
San Francisco, California, United States EPM Scientific Full timeJob DescriptionSeeking a highly experienced Regulatory Affairs professional to lead the NDA process through launch and provide regulatory leadership through the regulatory strategy of product development and approval.Responsibilities:Provide knowledge of global quality/regulatory guidelines and ensure requirements are met across programsPartner with internal...
-
Regulatory Affairs Specialist
4 weeks ago
San Diego, California, United States ACON Laboratories Full timeSenior Regulatory Affairs SpecialistWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at ACON Laboratories. As a key member of our regulatory affairs team, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.Key Responsibilities:Coordinate the preparation and...
-
Senior Regulatory Affairs Specialist
2 weeks ago
San Diego, California, United States BD (Becton, Dickinson and Company) Full timeJob Description SummaryAs a Senior Specialist in Regulatory Affairs, you will play a critical role in supporting the development, sustainment, and end-of-life activities of Medical Devices and Non-Medical Devices, as well as associated Software and Accessories, on a global basis from a Regulatory Affairs standpoint.About the RoleThis fully remote position...
-
Vice President, Medical Affairs Lead
3 weeks ago
South San Francisco, California, United States Alumis Full timeJob Title: Vice President, Medical AffairsAlumis Inc. is a precision medicines company with a mission to transform the lives of patients with autoimmune diseases. We are seeking a highly experienced and skilled Vice President, Medical Affairs to lead our Medical Affairs function and contribute to the development of our lead assets.Key...
-
Vice President of Academic Affairs
1 month ago
San Diego, California, United States Grossmont-Cuyamaca Community College District Full timeJob SummaryThe Grossmont-Cuyamaca Community College District is seeking a highly qualified Vice President of Academic Affairs to provide leadership and direction to college instructional programs, the library, and computer technology learning resources. This is a key leadership position that requires a strong commitment to student success, equity, and...
-
San Bernardino, California, United States California State University Full timeJob SummaryThe Associate Vice President for Student Affairs and Dean of Students is a key member of the Division of Student Affairs Leadership Team, reporting directly to the Vice President for Student Affairs. This leadership role oversees the establishment and training of hearing panels, assures the adjudication of student code of conduct violations, and...
-
Vice President of Academic Affairs
2 weeks ago
San Diego, California, United States Grossmont-Cuyamaca Community College District Full timeJob SummaryThe Grossmont-Cuyamaca Community College District is seeking a highly qualified Vice President of Academic Affairs to provide leadership and direction to college instructional programs, the library, and computer technology learning resources. This is a key leadership position that requires a strong commitment to student success, equity, and...
-
Senior Regulatory Affairs Specialist
1 month ago
San Diego, California, United States BioTalent Full timeSenior Regulatory Affairs SpecialistWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at BioTalent. This is a hybrid on-site role that requires at least 5-7+ years of hands-on Regulatory experience, including 510(k) authorship.Key Responsibilities:Document Coordination: Coordinate submission and review of documents for...
-
Senior Director of Regulatory Affairs
2 weeks ago
San Diego, California, United States Ignite Human Capital Full timeJob OverviewIgnite Human Capital is seeking a seasoned Senior Director of Regulatory Affairs to spearhead regulatory strategies and activities concerning the development and approval of cell therapy products.This pivotal role will provide strategic leadership, ensuring compliance with global regulatory standards while supporting organizational objectives.Key...
-
Senior Vice President Compliance
4 weeks ago
San Francisco, California, United States 5H0 Hub International Limited Full timeAbout 5H0 Hub International LimitedAt 5H0 Hub International Limited, we are committed to providing our clients with the best possible service and support. Our team of experts is dedicated to helping our clients achieve their goals and overcome any challenges they may face.Job Title: Senior Vice President ComplianceWe are seeking a highly skilled and...
-
Vice President, US Medical Affairs Director
1 month ago
San Francisco, California, United States Daiichi Sankyo, Inc. Full timeJob Title: Vice President, US Medical AffairsAbout the Role:Daiichi Sankyo, Inc. is seeking a highly skilled and experienced Vice President to lead our US Medical Affairs organization. As a key member of our Executive Leadership team, you will be responsible for creating, championing, and executing the strategic direction and long-term vision for our Company...
Senior Vice President of Regulatory Affairs
2 months ago
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, supported by esteemed partners including Frazier Life Sciences, 5AM Ventures, DCVC Bio, Crinetics Pharmaceuticals, and GordonMD Global Investments, alongside a collaborative agreement with Eli Lilly.
Role Summary
The Senior Vice President / Vice President of Regulatory Affairs (SVP/VP) serves as the principal leader overseeing all regulatory functions for the organization. This role acts as the primary liaison with regulatory bodies and encompasses comprehensive tactical regulatory responsibilities. The SVP/VP is proficient in formulating and articulating the regulatory strategy to align with corporate objectives, possessing substantial experience in engaging with regulatory agencies, particularly the FDA, and has successfully guided organizations through numerous FDA approvals, including NDAs and INDs. The ideal candidate is driven, purpose-oriented, and capable of effectively leading and collaborating with cross-functional teams.
Key Responsibilities
- Oversee all strategic and operational regulatory affairs tasks for the organization, serving as the principal author and facilitator for all regulatory submissions across development programs, ensuring timely execution and adherence to budgetary constraints.
- Act as the primary contact for all regulatory authorities, including the FDA and other relevant agencies.
- Evaluate data and assess the regulatory landscape to ensure alignment with business priorities.
- Develop 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 external partners.
- Provide training and interpretation of regulatory requirements to internal teams.
- Contribute as a member of the senior leadership team, offering regulatory guidance and participating in discussions on broader corporate strategies.
- Lead, mentor, and evaluate both direct and indirect reports, ensuring accountability in decision-making processes.
- Collaborate with cross-functional teams on regulatory activities and submissions, fostering a cooperative environment.
- Maintain up-to-date knowledge of regulatory standards and best practices.
- Fulfill additional responsibilities as required by business needs.
Qualifications
- Ph.D., Pharm.D., or an equivalent advanced degree in a scientific field.
- A minimum of 15 years of relevant experience in regulatory affairs or related areas within drug development, demonstrating progressive leadership roles in the pharmaceutical or biotechnology sectors, including at least 5 years in a regulatory leadership capacity.
- Extensive hands-on experience in regulatory strategy and documentation across nonclinical, clinical, and CMC domains, with a proven track record in global regulatory affairs.
- In-depth knowledge of FDA and EMA regulations, as well as international clinical trial regulations and ICH GCP, GMP, GLP guidelines.
- Exceptional interpersonal, organizational, and communication skills, both verbal and written.
- Strong problem-solving abilities and the capacity to work independently and collaboratively.
- Proficient in computer skills and Microsoft 365 applications.
Work Environment
This position may involve a flexible work schedule, with the possibility of remote work arrangements.
Compensation and Benefits
Radionetics offers a competitive compensation package, including bonus opportunities, equity, 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 paid holidays.
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 a policy of equal opportunity, ensuring that all qualified applicants receive equal consideration for employment without regard to race, color, national origin, ancestry, religion, sex, pregnancy, marital status, sexual orientation, gender identity and expression, age, physical and medical disability, medical condition, genetic information, military or veteran status, or any other protected class.
The above job description is intended to convey the general nature and level of work performed by individuals in this role and is not an exhaustive list of all responsibilities and requirements. Radionetics reserves the right to modify duties, education, experience, skills, or other requirements at any time.
