What are the responsibilities and job description for the Vice President, Regulatory Affairs position at Exokeryx, Inc.?
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 :
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.
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Salary : $310,000 - $350,000
