Position Summary 

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.  

Primary Responsibilities 

(not limited to the below and may evolve over time and change depending on business needs and individual expertise):  

  1. Lead the development and execution of global regulatory strategies for each of Star’s programs/molecules.  

  1. Contribute to company culture, strategy, and operations as member of the Star Management Team. 

  1. 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. 

  1. Serve as the primary point of contact for global regulatory authorities (e.g., FDA, EMA, PMDA, etc.), leading all communications and meetings.  

  1. 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. 

  1. Oversee the preparation and submission of all global regulatory filings, including INDs, CTAs, Investigator's Brochures (IBs), DSURs, and NDAs.  

  1. Build and maintain relationships with key stakeholders in the regulatory community.   

  1. Stay current on relevant evolving global regulations and guidance. 

  1. Collaborate with Clinical Development teams to ensure regulatory compliance in clinical trial design, conduct and reporting. 

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

  1. Provide expert guidance and support to internal stakeholders on all regulatory matters.  

  1. Develop and manage the Regulatory Affairs department budget. 

  1. Manage contract staff and vendors as needed to support regulatory activities 

  1. 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. 

  1. Performs other related duties as assigned. 

Requirements: 

  • 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. 

  • Performs other related duties as assigned. 

Education & Professional Experience 

  • Advanced Degree 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,  

  • 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.  

Salary Range  

The hiring salary range for candidates residing in California for this position is $252,000 to $315,000 annually.  This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation geographic location, individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data.  This position is also eligible for bonus, benefits, and participation in the Company’s stock option plan.  

*Please note the preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive listing of all activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.  

Star Therapeutics is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.  Star is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status.