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Senior Vice President / Vice President of Regulatory Affairs

Company: Allakos, Inc.
Location: San Carlos
Posted on: May 16, 2022

Job Description:

Senior Vice President / Vice President of Regulatory Affairs Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases. Allakos is committed to developing innovative therapies that transform patients' lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients. Position Summary: The Senior Vice President / Vice President of Regulatory Affairs will be responsible for setting regulatory strategy and will serve as a primary liaison with global regulatory agencies. This position is a successor for Head of Regulatory Affairs at Allakos. Your Role: Primary responsibilities include, but are not restricted to, the following:

  • Influence, develop and implement drug development approach to support worldwide registration policy. Promote and execute a productive relationship with regulatory and other health authorities.
  • Develop new approaches in anticipation of the evolving regulatory landscape.
  • Principle focus will be clinical trials OUS, global preparation for marketing applications and readiness for commercial activities.
  • Establish and maintain strong relationships with health authorities. Act as a credible, influential, and respected corporate spokesperson for interactions and negotiations with regulatory agencies on all matters relating to drug development, compliance and safety.
  • Develop strong and productive working relationships with key stakeholders throughout company. Communicate effectively to ensure an effective understanding of regulatory sciences and compliance.
  • Foster individual and group development by identifying and arranging appropriate assignments, formal training or other experiences. Prepare others to assume new or increased responsibilities in the future. Serve as role model in terms of coaching and providing development opportunities.
  • Work closely with marketing and other constituencies to help manage the product lifecycle of current products. Qualifications and Expertise:
    • PhD or MS with other relevant degree
    • Deep expertise in understanding and leading a biopharmaceutical regulatory function nonclinical, clinical and quality
    • Minimum of 15 years in the pharmaceutical field
    • BLA/NDA approvals; experience with post-marketing regulatory issues
    • Experience building a high-performance organization and developing people
    • Past experience in monoclonal antibodies, Pediatric Investigation Plans, and expedited approval pathways The salary is competitive and commensurate with experience and qualifications. The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

Keywords: Allakos, Inc., San Francisco , Senior Vice President / Vice President of Regulatory Affairs, Executive , San Carlos, California

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