Director, Regulatory Affairs

Regulatory Affairs Seattle, Washington


Description

Why Work for Us?

Innovation. Act with Integrity. Collaboration. Embrace Diversity. Care

We come from many countries, cultures, races, ethnicities, abilities and nationalities. We bring our passions including singing, biking, swimming, dancing, cooking, volunteering, parenting, coaching and much more! We are proud of our nearly equal balance of men and women and strengthened by our non-binary and transgender team members. Every employee belongs.

We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.

Company Description

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 professional who is looking to grow their career with our company. The Director/Senior Director, Regulatory Affairs is responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives, and in coordination with key internal stakeholders. The incumbent will provide leadership and strategic regulatory oversight for designated projects ensuring that the latest requirements and standards are met.

The individual will interface with outside regulatory agencies and business partners in regard to development, regulatory, and registration strategies. The Director/Senior Director of Regulatory Affairs will also provide line management, people development, and performance management as well as support/lead development and implementation of department policies. 

This position will report to the Head of Regulatory Affairs and will be based in our offices in Seattle WA.

As a condition of employment, Zymeworks requires all employees to be fully vaccinated against Covid-19 and provide verification of such. To be considered fully vaccinated, all 3 doses are required.

Key Responsibilities

  • Provides high level strategic and operational regulatory direction and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in domestic and international markets, regulatory strategic development plans and risk assessments, critical issue management and advice on Regulatory Agency interactions.
  • Provides leadership, coaching and feedback to the regulatory group; mentors and empowers personnel.
  • Uses extensive knowledge of US, EU and ICH regulatory requirements; is able to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate strategy.
  • Oversees the preparation and submission of documentation to support investigational and marketing registration packages throughout the world and ensure timelines are met.
  • Reviews sections of IND/CTA, BLA/MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements.
  • Liaises and negotiates with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite product approvals and labeling.
  • Maintains awareness of the global regulatory environment and assess the impact of changes on business and product development programs. Facilitates policy and development of the standard interpretation of global regulation.
  • Integrates functional expertise with business knowledge to solve problems and make good decisions to support overall corporate business strategy.
  • Trains, develops and manages an effective regulatory team both via direct and indirect reporting structure.
  • Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise and the provision of appropriate resources.
  • Manages the preparation of operating and personnel budgets and plans. Authorizes expenditures, oversees forecasting activities and communicates anticipated variances to senior management as required.
  • Responsible for assisting with the development, implementation and enforcement of regulatory processes.

Qualifications and Education

  • Ph.D. and 7+ years of work experience in pharmaceutical regulatory affairs, or B.S/M.S. and 10 years of work experience in biotech or pharmaceutical regulatory affairs
  • Preferred candidates will have experience working as a lead in Regulatory Affairs across two or more major geographic areas and prior experience with both small molecules and biologics. Experience in Japan and APAC region is a plus.
  • Familiarity with companion diagnostic development as part of a targeted therapeutic program while not essential, is helpful.
  • Experience in oncology required, lung, gastrointestinal (GI) or other solid tumours helpful.
Core Competencies, Knowledge and Skill Requirements
  • Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to establish and maintain effective working relationships
  • Strong leadership skills with the proven ability to manage, develop and empower employees
  • Thorough understanding of drug development processes and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends.
  • Extensive regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Regulatory Agencies, leading and managing regulatory teams, developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments.
  • Strong business acumen and ability to make sound decisions that contribute positively to the business strategy or interests.
  • Very strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (e.g., new competition, shifting market environment) and the ability to balance short-term needs with long-term vision.
  • Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism.
Communication and Interpersonal Skills
  • Excellent verbal and written skills; Able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to be internal and external stakeholders.
  • Skilled in conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussion.
  • Strong negotiating skills and ability to think creatively and develop creative solutions.
  • Ability to prioritize and handle multiple projects.
  • Proven ability to build trust and respect within the organization.
  • Ability to interact with external business partners and Regulatory Agencies.

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.

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