Senior Manager/Associate Director, Regulatory Affairs

Position: Senior Manager/Associate Director, Regulatory Affairs

Function: Clinical Development and Operations

Company: Phanes Therapeutics, Inc.

Location: San Diego, CA

Phanes Therapeutics is a clinical stage biotech company focused on innovative discovery research and clinical development in oncology. The company received three IND clearances from the FDA this year: PT199 for solid tumors, PT886 for pancreatic, GEJ and gastric cancers, and PT217 for small cell lung cancer (SCLC). In addition, both PT886 and PT217 have received orphan drug designations from the FDA. We are looking for motivated and passionate people to join us to help discover and develop new medicines and improve healthcare. We believe that innovative thinking, seamless execution, teamwork, and integrity are key values for building success. Our mission is to become a major source of innovation in the biotech and pharma industry.

At Phanes, we understand that scientific innovation is a challenging task and that’s why we are looking for exceptionally talented people to join us on our mission. We are committed to fostering an innovative and fun working environment where individuals can pursue creative ideas and deliver results, because we know that our success depends on how to realize the true potential of our people. We offer competitive compensation and excellent medical, dental and vision benefits, and excellent career growth opportunities.

This position is in the clinical development and operations function located at our R&D site in San Diego, CA. The candidate should have solid training and/or broad experiences in regulatory affairs, especially with regards to the development of oncology therapeutics. The candidate will work with project teams to advance preclinical lead molecules into the IND stage and coordinate regulatory activities. In addition, the candidate is expected to be skillful in integrating information from various functions and be articulate in communicating company regulatory strategy to internal and external stakeholders.

The candidate must be a team player and is expected to work with other scientific and clinical staff in advancing our programs through the clinic. Leadership skills in managing internal and external projects are required. Compensation will be commensurate with experience and skillset.

Key responsibilities:

  • Responsible for developing and implementing regulatory strategy.
  • Lead and review the preparation of content for INDs, BLA and/or NDA. Manage timelines and document workflow from draft through finalization for regulatory submissions.
  • Perform critical reviews of submission documents to ensure compliance with FDA and/or EMA regulatory requirements. Work with external regulatory partners as needed.
  • Serve as Health Authority point of contact and interface for meetings, teleconferences, etc. Prepare company personnel for interactions with health authorities and lead and participate in meetings with regulatory agencies as appropriate. Ensure that responses to FDA/EMA questions are handled in a timely manner. Begin developing effective relationships with Health Authorities.
  • Maintain working knowledge of regulatory guidance’s, laws and requirements related to Oncology, in addition to general regulatory knowledge.
  • Provide input to Standard Operating Procedure documents to ensure regulatory compliance.
  • Assist with all regulatory obligations at the clinical trial site level, as needed.

Qualifications:

  1. Bachelor's degree or higher with a minimum of 8 years of health regulatory biotech or pharmaceutical industry experience.
  2. A solid understanding of the drug product lifecycle from discovery to clinical trials to regulatory approval is required.
  3. Oncology clinical development and regulatory experience is highly preferred.
  4. Understanding of ICH and FDA regulatory requirements and guidelines specific to the areas of clinical research and development is required.
  5. Experience with preparation and critical review of initial INDs, IND amendments, DSURs and meeting briefing documents is required.
  6. Understanding of the regulatory submission and approval process along with experience interacting with health authorities is required.
  7. Proven ability to interact and work with external partners (consultants and CROs) with regards to IND and other regulatory filings.
  8. A proven track record of successfully working within a collaborative team environment and building positive relationships as an individual contributor is required.
  9. Excellent oral and written communication skills and strong organizational skills are required.