Senior Director Or Vice President, Regulatory Affairs

This role can be based in Durham, NC, Seattle, WA, or remotely.

Tune Therapeutics is a cutting-edge biotechnology company founded by world-class leaders in epigenome editing. At Tune, we strive to develop paradigm-changing cell and gene therapies that leverage epigenetic programming for the treatment of devastating diseases. We are building a highly skilled and dynamic team with expertise that spans drug discovery through commercialization. We are passionate about the science of epigenetic editing and its potential to transform patient care.

We are looking for the Head of Global Regulatory Affairs who will be responsible for the development and submission of regulatory filings globally. They will drive innovative regulatory strategies, lead the preparation and submission of high-quality briefing documents, INDs, CTAs, and eventually marketing applications (BLAs/MAAs) in close collaboration with internal research, nonclinical, CMC teams, and external partners including contract manufacturing organizations, contract research organizations, consultants, and collaborators.

Responsibilities:

• Lead negotiations with regulatory agencies to resolve and review issues; and shepherd proactive interactions with regulators globally
• Lead global submission strategy, as well as submission planning, authoring, review, and finalization
• Drive adherence to regulatory guidelines relevant for the development of epigenetic editing therapies. Author, review and approve, as necessary, internal documentation to ensure conformance with regulations and guidance
• Recruit talent and provide training, mentorship, and development opportunities for reports and team members
• Help shape and sustain an innovative and inclusive culture as a member of the Tune community
• Lead regulatory intelligence activities; monitor regulatory guidelines and trends; obtain and interpret global regulations and guidance and provide regulatory advice to program teams and functions
• Build regulatory organization in accordance with Tune’s growing needs.

Qualifications:

• Detail oriented; strong technical knowledge and science-based reasoning skills
• Critical thinking skills
• Strong leadership qualities including strategic thinking, innovation, mentoring, scaling, collaboration, etc.
• A minimum 13-16 years of experience for Senior Director or 15-18 years of experience for Vice President of relevant biotech or pharmaceutical industry regulatory experience, preferably with experience in cell and gene therapies. A Master’s degree in life sciences in biochemistry, chemistry, biology, or related pharmaceutical field including biochemical engineering is required and a PhD is preferred
• Strong knowledge of current drug development regulations and guidelines including ICH, FDA and EMA guidelines
• Ability to travel up to 10% required
• Excellent written and communication skills

The starting compensation range for this role is from $210,000-$255,000 annually for a Senior Director or $245,000-$300,000 annually for a Vice President (adjusted for location), based on skills, education and experience that is relevant to the position. Other components of total compensation include annual bonus and stock opportunities (based on eligibility).

Tune Therapeutics is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Tune Therapeutics is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment.

Explore Passionately. Innovate Boldly. Execute Selflessly. Come bring the song to life!