Director/Sr. Director Regulatory Affairs CMC
Director/Senior 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 Director/Senior 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.
-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.
·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 current 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.