Senior Director, Regulatory Affairs
Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics. Zymeworks’ suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates.
Zymeworks is looking for a Senior Director of Regulatory Affairs to join our growing Clinical department. This position will report to the Chief Medical Officer and will be based in Seattle, WA.
- Establishes department’s mission and goals and inspires an environment of shared purpose to accomplish goals through teamwork and across functional boundaries.
- Leads Regulatory Affairs’ activities with an emphasis on global regulatory strategy and the preparation, review and submission of documents to the FDA and other regulatory authorities.
- Develops and implements regulatory strategies and objectives based on current regulatory intelligence and collaboration with key stakeholders.
- Builds, grows and manages a high-functioning department with a focus on staff development and appropriate succession planning. Provides leadership, coaching and feedback; mentors and empowers personnel.
- Manages and coordinates the preparation of dossiers for various submissions types including INDs, CTAs, NDAs, amendments, supplements and annual reports.
- Tracks recurring regulatory activities and manages submission timelines ensuring all applications are filed in accordance with predetermined timelines.
- Provides support for drug safety regulatory interactions.
- Oversees interactions with FDA and other global regulatory agencies on product approvals, compliance issues and during audits/inspections.
- Interacts effectively with functional business units to secure acceptable documentation required for submissions. Ensures accuracy and compliance with current regulations and FDA guidance.
- Identifies and resolves issues with regulatory submissions.
- Oversees development of regulatory affairs quality systems, including standard operating procedures, document management, personnel training, and quality control processes.
- Responsible for oversight over regulatory operations, including preparation and submission of electronic dossiers, either through internal and/or external resources.
- Fosters effective and collaborative working relationships with fellow employees, management and external partners.
Qualifications and Experience
University degree in Pharmaceutical Sciences, Biology or Chemistry and considerable senior regulatory management experience or an equivalent combination of training and experience. RAC certification required.
Skills and Abilities
- Proven leadership skills with the ability to manage, develop and empower employees as well as create and sell a vision/strategy
- Excellent organizational skills and the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment
- Ability to think and act strategically, anticipate road-blocks and map out next steps
- Demonstrated high level of integrity and ethics
- Previous experience in leading submission activities, including IND submissions, IND maintenance (e.g. DSUR) (recent NDA or BLA experience a plus)
- Solid knowledge of USFDA and ICH guidelines and regulations. Prior experience interacting with Health Canada and EMEA required. Prior experience with ROW including China, South Korea, Taiwan and Singapore a plus
- Working knowledge of CMC regulatory requirements, with recent experience in clinical stage biologics development preferred
- Knowledge regarding internal and external options for electronic Regulatory publishing tools and MS Office
- Excellent communication skills—written, oral and presentation
- Flexible, cooperative approach to problem solving and excellent conflict resolution skills
- Highly detail-oriented
Why Work for Us?
Zymeworks’ employees are passionate, engaged and extremely motivated to succeed. We are excited by the cutting-edge science and technology, the endless possibilities this union holds and the sheer opportunity to be a part of something big. To learn more about Zymeworks Inc. and our current openings, please visit our website at www.zymeworks.com.
We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.