Lycia Therapeutics, Inc. is a biotechnology company leveraging its lysosomal targeting chimera (LYTAC) platform from Founder and Chemistry Nobel Laureate 2022, Carolyn Bertozzi, to discover and develop first-in-class therapeutics that degrade extracellular and membrane-bound proteins. Lycia’s next generation degraders harness the cell’s endogenous lysosomal trafficking and degradation machinery with the potential to degrade targets previously considered to be intractable, across a spectrum of indications. After raising $105 million in capital in 2021, Lycia is advancing an internal pipeline of novel degraders and has entered a strategic collaboration with Eli Lilly to address key unmet medical needs. In May 2024, Lycia Therapeutics completed a $106.6 million series Series C financing to advance its pipeline of LYTAC extracellular protein degraders to the clinic. Lycia is headquartered in South San Francisco. Lycia is headquartered in South San Francisco. Visit https://lyciatx.com/ for more information.
The Role:
Lycia Therapeutics is seeking an innovative Head of Regulatory Affairs with a strong background in global regulatory strategy development to support the development of Lycia programs. 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 Head of Regulatory Affairs will work in conjunction with various stakeholders across functional areas within the company and with external partners. This role will serve as the primary point of contact for assigned regulatory agencies. At Lycia, you will be instrumental in shaping the development trajectory of our innovative therapeutic candidates and bringing transformative therapies to patients in need.
Key Responsibilities:
Oversees all global regulatory strategy and operations planning for related activities
Directs the strategy (time, tone, and content) of interactions with the respective regulatory health authorities’ including the request, preparation and execution of meetings with regulatory authorities for product specific issue and policy related issues.
Develop and execute innovative regulatory strategies for each program’s drug development that can include multiple parallel disease indications, including obtaining global health authority designations to support expedited pathways.
Provides leadership in the design and execution of strategies for complex regulatory submissions in close collaboration with other company functions.
Stays informed of global regulatory requirements.
Acts as the liaison between FDA and other global health authorities
Compile and author documents for submission to regulatory agencies
Lead the authoring, review, approval, and submission process for IND and CTA submissions.
Play a key role in planning, preparation, drafting, and review of regulatory documentation, including IND/CTA/GMO/BLA/MAA submissions, regulatory interactions, and responses to queries from competent authorities as required for the investigation and registration of drugs in the US and ex-US countries.
Ensure cross-functional alignment among stakeholders involved during key steps across multiple projects simultaneously
Requirements:
B.A./B.S. required; M.S., Ph.D., PharmD, MD, or other related advanced scientific degree strongly preferred
Over 10 years of progressive advancement within global regulatory affairs in the pharmaceutical /biotech industry.
Prior regulatory experience in drug development with demonstrated leadership of successful submissions to FDA (e.g., INDs, briefing packages, NDAs) and other regulatory agencies (e.g., EMA)
A thorough understanding of the drug development process along with knowledge of the developing regulations and guidelines.
Familiar with current regulatory legislation, industry trends, and health care business practices in the global arena, including but not limited to the US.
Ability to build collaborative relationships both internally and externally.
Flexible and dynamic interpersonal approach, entrepreneurial by nature, a collaborative team player who works well with physicians, scientists, managers, peers, and staff.
Ability to manage in a consensus environment through teamwork, trust and shared expectations, influencing strategic direction of complex global regulatory issues, solicit information, listen well, persuade others, make important decisions and shape outcomes
The expected base salary range for this role is $X-$X t. We encourage candidates of all levels to apply as there is often flexibility on job title and responsibilities. Compensation will be based on a variety of factors, including experience, qualifications and internal equity. Lycia offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package. 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, sexual orientation, age, marital status, veteran status, or disability status.