VP. Regulatory Affairs

VP, Regulatory Affairs

We are seeking a strategic and results-oriented leader to oversee all regulatory activities for our hematology/immunology pipeline, with an initial focus on the upcoming 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. The position will report to the Chief Development Officer.

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.
• 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 regulatory guidance to ensure trials are conducted in accordance with regulatory standards.
• Provide expert guidance 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

Supervisory Responsibilities

• People managers at Star practice effective employee engagement, strategy implementation, and team building. Managers provide teams with the clarity and context they need to make good decisions. Actively coach employees/team and stay involved in the work being done around them. Motivate direct reports by providing positive feedback and skills development. Act as a liaison with senior level management and other department managers by developing productive, collaborative relationships and utilizing clear and effective communication. Uphold the mission, vision and values of the company.
• Performs other related duties as assigned.
• Attract, hire, and develop top talent, coaching your team to grow and excel.
• Provide clarity and strategic direction, empowering your team to make smart decisions and stay deeply engaged with their work.
• Motivate direct reports by providing positive feedback and skills development.
• Cultivate a positive, high-performing environment through active engagement and team building.
• Build productive and collaborative relationships across the business and embody Star's company values in every interaction.

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 rate 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.

Our Core Values

The below core values drive all that we do here at Star. We are looking for like-minded individuals that feel passionately about these same values to join our team.

• 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.

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.

Star is headquartered in South San Francisco, CA. More information about Star can be found on our website.

Star offers a competitive salary and benefits package and we take pride on being a best place to work. We're also a company where you can flourish and grow your career, learn and explore, and make connections.

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.

We anticipate the base salary for the VP, Regulatory Affairs position in our South San Francisco, CA office to range from $276,000 to $345,000 annually and will depend on current market data and the candidate's qualifications for the role, including education, experience and geographic location. This position is also eligible for bonus, benefits, and participation in Company's equity plan. The compensation described above is subject to change and could be higher or lower than the range described based on several factors.

Qualified candidates should apply via our careers page.