Careers

Director, Regulatory Affairs

Job Description

The Sr. Director will serve as the strategic leader for defining and implementing the Regulatory strategy for the development of Apexigen’s product candidates. He/She will lead, grow and oversee all aspects of Regulatory Affairs, serve as the primary corporate liaison/contact with Regulatory Compliance activities (GcP and GLP) and provide regulatory leadership to cross-functional teams responsible for global programs ensuring effective communication with business partners and representatives of the US Food and Drug Administration and other Health Authorities worldwide. In addition, the position will assist corporate senior management in understanding Regulatory strategies/processes while developing corporate objectives and understanding the impact of decisions across therapeutic areas.

Essential Duties & Responsibilities

  • Provide regulatory strategic and tactical leadership for drug development projects, including health authority interactions, regulatory submissions and other regulatory requirements in line with corporate objectives, timelines and budgets
  • Establish and develop regulatory policies, procedures and best practices commensurate with the requirements of a rapidly growing company
  • Serve as liaison with FDA and other Health Authorities, including leading meetings and preparations to facilitate expedited approval of original applications and supplements
  • Build a strong performing regulatory team, providing leadership, and when necessary, contribute hands on support in managing, planning, coordinating, and preparing all documents submitted to FDA and other Health Authorities in support of INDs, BLAs, MAAs, DMFs, CTAs, amendments, safety reports, and annual updates
  • Ensure completeness and accuracy of information provided in regulatory submissions.
  • Continually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs. Provide training on applicable requirements for scientific staff as required
  • ISO Management Representative, host FDA, European Union, ISO and other external audits as required by Senior Management
  • Maintain, prepare, review, and implement Regulatory Affairs standard operating procedures
  • Prepare, review, implement and maintain product technical files
  • Review and monitor risk management process including post production risk
  • Prepare, review, implement, and maintain the quality manual
  • Ensure that all departments are aware of new or evolving regulations – FDA, European Union, and ISO
  • Manage the Customer Complaints Program
  • Oversee preparation of regulatory presentations for internal governance meetings

Qualifications

  • BS Required. Advanced degree is preferred (MS/PhD/PharmD)
  • 10+ years industry experience in regulatory affairs in bio/pharma industry
  • Strong knowledge of FDA regulations and EU CTA requirements
  • Delivery of a number of major applications (NDA/BLA/MAA/JNDA etc.) with both early and late stage drug development
  • Comfortable with setting strategies as well as taking a hands-on approach to all regulatory activities
  • Experience with preparing regulatory documents including new INDs, safety reports, Investigator Brochures, DSURs, PSURS, briefing packages and other regulatory submissions required
  • Experience interacting/negotiating with regulatory authorities (e.g. FDA, EMA, etc.)
  • Strong leadership and communication skills and experience in working with multiple functional areas
  • Prior experience in the immunology therapeutic area
  • Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions.
  • Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance
  • Ability to motivate and lead others
  • Team player, ability to thrive in a collaborative and fast-paced environment and work well within cross-functional teams
  • Excellent oral communication and writing skills


All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability

To Apply

Email resumes to career@apexigen.com. Please reference Job ID: Director, Regulatory Affairs

Apexigen is an equal opportunity employer