Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company’s Native Complex Platform™ recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular context. This approach enables novel access to modern structural and screening technologies used in industrial-scale drug discovery for the entire class of GPCRs. Septerna has an emerging pipeline of GPCR-targeted small molecule programs with potential for growth to target many GPCRs that have been undruggable and unexploited to date.
We are excited to expand our multidisciplinary team of individuals focused on creating revolutionary medicines to address the unmet needs of patients. At Septerna we strive to embrace diversity of thought, expertise, and background through collaboration. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission. We share a fearless pursuit of ground-breaking innovations and cultivate an environment where our employees succeed by learning from each other and working as a team.
We are committed to the development of meaningful therapeutics for patients with indications of high unmet need. This is a tremendous opportunity to work with talented individuals on the frontlines of therapeutic discovery and development. You will directly help move therapies through preclinical research, positioning them for success in the clinic. The successful candidate will add their passion, unique talents, and expertise to a dynamic team motivated to discover new disease-modifying therapeutics for patients in a fast-paced environment.
For more information see: www.septerna.com.
About The Role
Septerna has an exciting new opportunity to join the team as a Vice President, Regulatory Affairs. Reporting to the Chief Medical Officer. The VP, Regulatory Affairs will join the Senior Leadership Team and provide key leadership for all Regulatory Affairs activities for Septerna to drive product development plans, develop innovative global regulatory strategies, and ensure compliance with regulatory guidelines. Responsible for regulatory negotiations and the preparation and submission of high-quality briefing documents, INDs, CTAs, and marketing applications (BLAs/MAAs), in close collaboration with Nonclinical, CMC, Quality, and Clinical teams, as well as external consultants and collaborators, as needed. Must be a dynamic leader with outstanding strategic, communication, and collaboration skills.
Key Responsibilities:
- Serve as primary corporate interface for regulatory authorities, within and outside the U.S.
- Drive the planning and implementation of meetings with regulatory authorities and effectively represent Septerna in regulatory interactions.
- Understand and interpret complex scientific issues for assigned projects as they relate to regulatory requirements and strategy, providing guidance on appropriate regulatory strategy.
- Proactively identify regulatory issues and offer creative solutions and risk mitigation strategies.
- Manage and implement the planning, authoring, and submission of high-quality briefing documents and clinical trial applications across the US, EU, Japan, and ROW.
- Be accountable for all submissions and approvals for assigned project(s).
- Serve as the direct point of contact with health authorities; lead and manage FDA/global health authority interactions and meetings for project responsibilities and prepare and submit responses to queries.
- Ensure adherence to global regulatory guidelines for the development of oncology products; author, review, and approve internal documentation to ensure regulatory compliance.
- Accountable for the accuracy of regulatory submissions and communications with health authorities.
- Partner closely with Nonclinical, CMC, Quality, and Clinical teams to meet submission deadlines and achieve timely approvals for clinical trial applications.
- Monitor global regulatory guidelines and anticipate trends that may impact the regulatory landscape to strengthen the product development plan and adopt regulatory strategies accordingly.
- Identify and implement processes, procedures, and systems that are appropriate for Septerna’s size and stage of growth.
- Provide regulatory assessments to due diligence teams, evaluating risks, requirements, and opportunities associated with collaborations.
- Accountable for timely adverse event reporting to regulatory authorities
- Ensure compliance with SOPs, ICH, GCP, and other national and international regulatory requirements.
- Undertake additional duties and responsibilities as required.
What You Bring:
- Bachelor’s degree in life sciences, biochemistry, chemistry, biology, or a related pharmaceutical field, including biochemical engineering; Master’s degree or Ph.D. preferred.
- Minimum 15 years of relevant biopharmaceutical industry experience, with at least 10 years management role in Regulatory Affairs (precision medicine experience preferred).
- Experience in all phases of regulatory submissions and interactions; international experience also required, along with direct contact and negotiation experience with the FDA.
- Strong experience interacting with regulatory health authorities and submitting CTA/IND and BLA/MAA filings.
- Rare disease experience is preferred.
- Familiarity with Chemistry, Manufacturing, and Control (CMC), Pharmacovigilance, and Quality, and how they intersect with Regulatory Affairs.
- Strong knowledge of drug and small molecule development regulations and guidelines, including ICH, FDA, and EMA.
- Excellent written and verbal communication skills, with strong technical and regulatory writing expertise.
- Strong leadership qualities, including strategic thinking, innovation, mentoring, and collaboration.
- Thrives in a highly entrepreneurial biotech environment.
The anticipated salary range for candidates who will work in South San Francisco, CA is $310,000 - $350,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.
Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited. We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Septerna participates in the E-Verify program. California Consumer Privacy Act Privacy Notice For Job Applicants. If you are a California resident, click here for our CCPA Notice. 
