Star Therapeutics
VP Regulatory Affairs (Contractor)
Star Therapeutics, South San Francisco, California, us, 94083
We are seeking a strategic and results-oriented VP, Regulatory Affairs leader (Contractor) to oversee all regulatory activities for our hematology/immunology pipeline, with an initial focus on the Phase 3 clinical trial for our lead candidate, VGA039. You will be responsible for developing and implementing comprehensive regulatory strategies to ensure timely and successful interactions with global health authorities. This role involves close collaboration with cross‑functional project teams in planning and execution of development strategies while providing leadership to global regulatory submissions. This position reports to the Chief Development Officer.
OUR CORE VALUES
Patients Are Our Center of Gravity: We partner with patients in unique ways, to uncover and address their unmet needs.
Propelled by Data, Guided by Intuition, Informed by Expertise: We boldly explore new diseases, novel biology, and smart ways of working with a sense of urgency.
Mission Ready Crew: With courage and agility, we opportunistically challenge conventional wisdom and foster an environment of respect and continuous growth.
RESPONSIBILITIES
Lead the development and execution of global regulatory strategies for each of Star’s programs/molecules.
Contribute to company culture, strategy, and operations as member of the Star Management Team.
Strategize, lead, write, and/or supervise the development and submission of documents or plans (e.g. Orphan, Break‑Through, Fast‑Track, Accelerated‑Approval, Diversity, and Pediatric Plans) to regulatory agencies to support development goals.
Serve as the primary point of contact for global regulatory authorities (e.g., FDA, EMA, PMDA, etc.), leading all communications and meetings.
Collaborate with cross‑functional teams (Clinical Development, CMC, Quality Assurance) to ensure regulatory compliance throughout the development process and ensure cross‑functional alignment during key steps across multiple projects simultaneously.
Oversee the preparation and submission of all global regulatory filings, including INDs, CTAs, Investigator’s Brochures (IBs), DSURs, and NDAs.
Inform leadership team of regulatory status of products and significant regulatory issues, including partnering with departments outside of Regulatory, who are responsible for the content for a submission, to ensure quality Regulatory submissions are made on time.
Provide regulatory guidance to ensure trials are conducted in accordance with regulatory standards.
Build and maintain relationships with key stakeholders in the regulatory community.
Stay current on relevant evolving global regulations and guidance.
Collaborate with Clinical Development teams to ensure regulatory compliance in clinical trial design, conduct and reporting.
Provide interpretation of FDA and other regulatory issues to ensure trials are conducted in accordance with regulatory standards.
Provide expert regulatory guidance, training and support to internal stakeholders on all regulatory matters.
Develop and manage the Regulatory Affairs department budget.
Manage contract staff and vendors as needed to support regulatory activities.
Perform other related duties as assigned.
EDUCATION, EXPERIENCE & QUALIFICATIONS
Advanced Degree (PhD, PharmD, MD) in a scientific discipline (pharmacology or toxicology preferred) or equivalent experience.
Minimum 15 years of progressive advancement and experience in global regulatory affairs within the pharmaceutical or biotechnology industry.
Minimum of 5 years experience with rare disease.
Demonstrated strong track record of success in late‑stage drug development.
In‑depth knowledge of global regulatory requirements with a particular focus on the FDA, EMA, and PMDA.
Extensive experience in the preparation and submission of INDs, CTAs, and other regulatory filings (e.g. Orphan, Break‑Through, Fast‑Track, Accelerated‑Approval, Diversity, and Pediatric Plans) including for global development; strongly prefer previous Phase 3 NDA/global submission experience.
Excellent writer and oral communicator; strong interpersonal, leadership, and people‑management skills.
Experience directly writing submission documents that support regulatory filings and clinical trials.
Must be comfortable and effective as BOTH an individual contributor and collaborative team player in a fast‑paced and dynamic small‑biotech environment, and throughout the company’s growth.
Flexible, creative thinker and problem‑solver.
Excellent organizational skills and attention to detail.
Excellent time‑management skills with a proven ability to meet deadlines.
Proficient with Microsoft Office Suite or related software.
ABOUT STAR THERAPEUTICS Star Therapeutics is a Phase 3 clinical‑stage biotechnology company that aims to discover and develop best‑in‑class antibody therapies to transform the lives of patients with serious diseases. Founded by former True North executives, Star has built a team with significant scientific, clinical, regulatory, and commercial experience that has a demonstrated track record of success and is backed by top‑tier biotech investors. We pride ourselves on our collective passion in bringing innovative therapies to the clinic and are committed to patients for whom no or limited treatment options exist.
Equal Opportunity Employer We are an equal‑opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender identity, sexual orientation, age, marital status, veteran status, or disability status.
Compensation We anticipate the hourly pay for the VP, Regulatory Affairs (Contractor) position in our South San Francisco, CA office to range from $175 to $210 per hour and will depend on current market data and the candidate’s qualifications for the role, including education, experience and geographic location. The compensation described above is subject to change and could be higher or lower than the range described based on several factors.
Application Information Qualified candidates should apply via our careers page at:
https://star-therapeutics.com/our-careers/ . Please note this is not a fully remote position. NO PHONE CALLS or AGENCIES, please.
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OUR CORE VALUES
Patients Are Our Center of Gravity: We partner with patients in unique ways, to uncover and address their unmet needs.
Propelled by Data, Guided by Intuition, Informed by Expertise: We boldly explore new diseases, novel biology, and smart ways of working with a sense of urgency.
Mission Ready Crew: With courage and agility, we opportunistically challenge conventional wisdom and foster an environment of respect and continuous growth.
RESPONSIBILITIES
Lead the development and execution of global regulatory strategies for each of Star’s programs/molecules.
Contribute to company culture, strategy, and operations as member of the Star Management Team.
Strategize, lead, write, and/or supervise the development and submission of documents or plans (e.g. Orphan, Break‑Through, Fast‑Track, Accelerated‑Approval, Diversity, and Pediatric Plans) to regulatory agencies to support development goals.
Serve as the primary point of contact for global regulatory authorities (e.g., FDA, EMA, PMDA, etc.), leading all communications and meetings.
Collaborate with cross‑functional teams (Clinical Development, CMC, Quality Assurance) to ensure regulatory compliance throughout the development process and ensure cross‑functional alignment during key steps across multiple projects simultaneously.
Oversee the preparation and submission of all global regulatory filings, including INDs, CTAs, Investigator’s Brochures (IBs), DSURs, and NDAs.
Inform leadership team of regulatory status of products and significant regulatory issues, including partnering with departments outside of Regulatory, who are responsible for the content for a submission, to ensure quality Regulatory submissions are made on time.
Provide regulatory guidance to ensure trials are conducted in accordance with regulatory standards.
Build and maintain relationships with key stakeholders in the regulatory community.
Stay current on relevant evolving global regulations and guidance.
Collaborate with Clinical Development teams to ensure regulatory compliance in clinical trial design, conduct and reporting.
Provide interpretation of FDA and other regulatory issues to ensure trials are conducted in accordance with regulatory standards.
Provide expert regulatory guidance, training and support to internal stakeholders on all regulatory matters.
Develop and manage the Regulatory Affairs department budget.
Manage contract staff and vendors as needed to support regulatory activities.
Perform other related duties as assigned.
EDUCATION, EXPERIENCE & QUALIFICATIONS
Advanced Degree (PhD, PharmD, MD) in a scientific discipline (pharmacology or toxicology preferred) or equivalent experience.
Minimum 15 years of progressive advancement and experience in global regulatory affairs within the pharmaceutical or biotechnology industry.
Minimum of 5 years experience with rare disease.
Demonstrated strong track record of success in late‑stage drug development.
In‑depth knowledge of global regulatory requirements with a particular focus on the FDA, EMA, and PMDA.
Extensive experience in the preparation and submission of INDs, CTAs, and other regulatory filings (e.g. Orphan, Break‑Through, Fast‑Track, Accelerated‑Approval, Diversity, and Pediatric Plans) including for global development; strongly prefer previous Phase 3 NDA/global submission experience.
Excellent writer and oral communicator; strong interpersonal, leadership, and people‑management skills.
Experience directly writing submission documents that support regulatory filings and clinical trials.
Must be comfortable and effective as BOTH an individual contributor and collaborative team player in a fast‑paced and dynamic small‑biotech environment, and throughout the company’s growth.
Flexible, creative thinker and problem‑solver.
Excellent organizational skills and attention to detail.
Excellent time‑management skills with a proven ability to meet deadlines.
Proficient with Microsoft Office Suite or related software.
ABOUT STAR THERAPEUTICS Star Therapeutics is a Phase 3 clinical‑stage biotechnology company that aims to discover and develop best‑in‑class antibody therapies to transform the lives of patients with serious diseases. Founded by former True North executives, Star has built a team with significant scientific, clinical, regulatory, and commercial experience that has a demonstrated track record of success and is backed by top‑tier biotech investors. We pride ourselves on our collective passion in bringing innovative therapies to the clinic and are committed to patients for whom no or limited treatment options exist.
Equal Opportunity Employer We are an equal‑opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender identity, sexual orientation, age, marital status, veteran status, or disability status.
Compensation We anticipate the hourly pay for the VP, Regulatory Affairs (Contractor) position in our South San Francisco, CA office to range from $175 to $210 per hour and will depend on current market data and the candidate’s qualifications for the role, including education, experience and geographic location. The compensation described above is subject to change and could be higher or lower than the range described based on several factors.
Application Information Qualified candidates should apply via our careers page at:
https://star-therapeutics.com/our-careers/ . Please note this is not a fully remote position. NO PHONE CALLS or AGENCIES, please.
#J-18808-Ljbffr