Sr Director/Director Regulatory Affairs – Job #1027
This is an individual contributor role that will be responsible for setting global regulatory strategy. Additionally this individual will be the primary liaison with global regulatory agencies.
- 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 in-line brands and products.
- Monitors the Quality Assurance programs and activities; this includes Contract Services Provider auditing programs, as well as the review and approval of Standard Operating Procedures, investigations, specifications, methods, reports (analytical and process), product complaints and manufacturing records.
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.
Interested applicants please send resume to firstname.lastname@example.org and reference Job #1027.
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.