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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