Director of Regulatory
Location: Durham, NC, Seattle, WA, or remote
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 seeking a Regulatory Director to oversee the planning, scheduling, and coordination of global submissions. This role involves close collaboration with Internal Research, Nonclinical, and CMC teams, as well as external partners including contract research organizations (CROs), consultants, and collaborators. The Regulatory Director will be responsible for external vendor oversight, budget management, and the preparation and submission of global regulatory documents.
You will have the following technical responsibilities:
- Manage global submissions, including pre-planning, tracking, assembly, submission, and archiving of regulatory documents in collaboration with external CROs.
- Ensure the quality, accuracy, and compliance of submission documents, meeting 'Approved for Submission' requirements.
- Oversee external vendors, associated budgets, and timelines.
- Utilize project management and planning tools to ensure timely electronic assembly of submissions in accordance with health authority standards.
- Identify resources and business needs for regulatory activities.
- Author Standard Operating Procedures (SOPs), Work Instructions, and Workflows for the regulatory function, ensuring practices conform to current health authority and industry submission standards.
- Source, manage, and disseminate regulatory guidance relevant to submission standards cross-functionally.
- Participate in interactions with global health agencies to resolve review issues and manage submission amendments.
- Contribute to an innovative and inclusive culture within the Tune community.
The qualified candidate will possess the following education and experience:
- 8-10 years of relevant experience in the biotech or pharmaceutical industry, preferably with cell and gene therapies.
- Bachelor’s degree in Life Sciences, Biochemistry, Chemistry, Biology, or related Pharmaceutical fields.
- Strong knowledge of current drug development regulations and guidelines, including ICH, FDA, and EMA guidelines.
- Excellent written and verbal communication skills.
- Strong technical knowledge and attention to detail.
- Self-motivated, flexible, and creative leader, able to embrace risk, prioritize tasks, and thrive in a fast-paced, demanding environment.
- Science-based reasoning skills.
- Ability to travel up to 10%.
The starting compensation range for this role is from $150,000 to $190,000 annually (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.
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