Vice President, Regulatory Affairs
Why Work for Us?
Innovation. Act with Integrity. Collaboration. Embrace Diversity. Care
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We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.
Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics, initially focused on the treatment of cancer. 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 seeking a highly motivated Vice President, Regulatory Affairs who is looking to grow their career with our company. The Vice President, Regulatory Affairs will provide strategic leadership and oversight to the Regulatory Affairs organization. This individual is responsible for providing thought leadership and advising on tactical execution for objectives, policies and programs related to marketing approval and life cycle management.
This position will report to the Senior Vice President, Regulatory Affairs and will be located in either Seattle, WA, Vancouver, BC, or remote within the United States.
Job Description and Responsibilities
- Develop strategic vision for function and drive implementation through collaboration with internal partners and across products.
- Provide cutting-edge thought leadership at all levels of the company and externally.
- Build, develop and retain a talented and engaged team of regulatory affairs professionals, set a compelling vision, and inspire teams to work effectively.
- Partner closely with commercial, clinical development and medical affairs to design and implement launch strategies and tactics on life-cycle planning.
- Establish strategic plans in partnership with SVP and oversee the implementation of Regulatory strategies across programs resulting in quality applications, including MAAs, that execute on company goals
- Create and recommend development plans incorporating regulatory strategies designed to utilize efficient regulatory pathways and to maximize chances of successful registration
- Lead the planning and implementation of meetings with regulatory agencies and ensure Zymeworks is effectively represented
- Manage the reviews of documents to be submitted to regulatory agencies, ensuring they meet the high standards of the company, and fulfil strategic goals and objectives
- Monitor current and proposed regulatory issues and trends and advise management on events of significance for Zymeworks’ business interests
- Design and implement processes, procedures, and solutions for optimization and efficiency commensurate with departmental growth
- Provide Regulatory assessment to due diligence teams in terms of risks, requirements, and opportunities associated with potential in-licensed assets
- Bachelor’s degree in a relevant scientific discipline required, advanced degree (MS, PhD, etc) preferred
- A minimum of 15 years of pharmaceutical/biotech industry experience
- A minimum of 12 years of regulatory experience in development programs,
- A minimum of 5 years recent oncology therapeutic area experience required
- Deep knowledge and understanding of the drug development process and regulatory requirements
- Significant number of years successfully working with the FDA, utilizing novel regulatory pathways (Breakthrough Therapy Designation, Real Time Oncology Review, Assessment Aid) and applying creative approaches during negotiations
- Experienced in the full range of regulatory submissions from IND to NDA/BLA and ex-US equivalents.
- Demonstrated strategic thinking ability and drive for successful outcomes
- Ability to synthesize complex problems into a strategy and tactics.
- Proven ability to thrive in a collaborative, cross-functional and dynamic environment while achieving company objectives.
- Strong verbal and written communication skills
- Demonstrated ability to lead and develop a high-performing team, with ability to mentor and inspire team members at all levels
- An equivalent combination of education and experience may be considered
- Adhere to the highest degree of professional standards and strict confidentiality on matters that require discretion
- Ability to travel as needed within the United States
NOTE TO EMPLOYMENT AGENCIES: Zymeworks values our relationships with our Recruitment Partners. We will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.