Executive Director, Regulatory Affairs CMC
Company: Allakos Inc
Location: Redwood City
Posted on: May 27, 2023
Job Description:
Exec Director Regulatory Affairs/CMC
Allakos Inc. is a dynamic clinical-stage biopharmaceutical company
developing first-in-class antibody-based therapeutics to treat
allergic and inflammatory diseases.
The Executive Director, CMC Regulatory Affairs is responsible for
developing and directing the regulatory CMC strategy, objectives,
and programs pertaining to development and marketing of drug
products.
They will:
-Lead teams with regulatory CMC responsibility for support of
development, registration and life cycle support, and CMC
regulatory strategy for United States and EU.
-Partner with regulatory support functions
-Partner with Quality, Manufacturing, Process Development, and
Supply Chain
-Be the key interface between the Regulatory and the Technical
Operations functions.
Responsibilities:
- Creates and implements CMC regulatory strategies for CTA
submissions and marketing applications. This role will have
accountability for regulatory CMC as well as represents regulatory
on key internal decision making teams. This role may oversee the
work of junior CMC regulatory staff.
- Proactively partners with Technical Operations counterparts on
processes and program prioritization.
- Proactively partners with the Head of Regulatory on the
development of the regulatory strategy .
- Functions as the regulatory CMC lead , working with other
Regulatory colleagues to drive regulatory strategies.
- Provides proactive guidance to internal groups (Quality,
Manufacturing, etc) based on technical and CMC regulatory knowledge
towards development of strategic and tactical plans. Identify and
assess regulatory risks associated with assigned projects.
- Leads the development of strategic CMC plans and tactical
implementation for the creation and submission of Regulatory
documents, e.g., INDs, BLAs, CTAs, MAAs, and other relevant
regulatory filings
- Serves as corporate liaison for CMC with regulatory Health
Authority (HA) to develop effective professional relationships as
well as a positive company image.
- Effectively leads key CMC focused meetings with HAs to ensure
full discussion of issues and opportunities.
- Provides guidance to all appropriate departments to assure
compliance with applicable regulations.
- Remains knowledgeable about current regulations and guidance,
interprets and notifies appropriate personnel and works with
regulatory policy/intel as appropriate.
- Makes recommendations for regulatory department operating
procedures. May be responsible for creating and reviewing SOPs as
needed.
- Leads and/or participates in regulatory and technical operation
initiatives to improve processes and ways of working, keeping
currently with approaches to regulatory strategy and
submissions.
- Actively trains/mentors junior staff; provides broader guidance
on regulatory interpretation to staff inside and outside Regulatory
Affairs
- May supervise Regulatory Affairs team members. Qualifications
and Expertise:
- BS, BSc, MS, MSc, PhD, PharmD, in science or healthcare
preferred or equivalent relevant experience.
- 15 years of Regulatory CMC experience as well as additional
experience in the biopharmaceutical industry in other areas. The
regulatory experience should be broad (across the life cycle of
pharmaceutical products and across main regions such as US, EU,
Japan and Canada) to ensure appropriate leadership and mentoring
for regulatory staff.
- Successfully prepared and filed a BLA, preferably for a
monoclonal antibody or therapeutic protein,
- 5+ years of management experience preferred
The salary is competitive and commensurate with experience and
qualifications.
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, Redwood City , Executive Director, Regulatory Affairs CMC, Executive , Redwood City, California
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