Manager, Regulatory Affairs

Seattle, United States

Zymeworks

Posted on: October 16, 2020

Closing: November 15, 2020

Salary: Undisclosed

Position Type: Full Time

Job 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.

About the Position

The Regulatory Affairs Manager will be responsible for leading regulatory efforts for early stage products as well as for indications as they advance to Phase 3. Regulatory representation on cross-functional teams, oversight of routine and key submissions in the US and globally, and leading Regulatory Agency interactions are within the scope of this role.

This position will report to the Director, Regulatory Affairs and will be based in Seattle, WA.

Key Responsibilities

  • Oversee the preparation of regulatory submissions including IND submissions, clinical trial applications, and their amendments
  • Contribute and support major submissions including BLA and other marketing applications
  • Manage responses to Regulatory Agency queries in a timely manner
  • Act as the sponsor contact with Health Authorities
  • Prepare documents for and lead Regulatory Agency interactions
  • Represent regulatory in cross-functional teams and communicate regulatory requirements to ensure execution of the regulatory strategy
  • Develop and implement regulatory strategies to meet project deliverables and mitigate potential regulatory risks
  • Contribute to establishing department processes and participate in SOP and other process development

Qualifications and Education

  • Minimum 5-8 years of relevant experience in regulatory affairs with drug or therapeutic biologic products. Experience in oncology strongly preferred.
  • Experience in the preparation and submission of regulatory documentation to support clinical applications, including US IND; oversight of CROs performing submissions on behalf of the sponsor
  • Requires knowledge of global health authority regulations and guidelines including FDA, EMA, Health Canada and ICH
  • BS in a life sciences discipline; advanced degree preferred but not required
  • Excellent verbal and written communication skills
  • Strong technical/analytical skills to identify and solve problems independently
  • Proven ability to manage multiple projects, identify and resolve regulatory issues
  • Ability to work independently with minimal supervision or direction
  • Excellent organizational skills, able to work on a number of projects under tight timelines
  • Excellent verbal and written communication skills
  • Ability to work independently with minimal supervision or direction

Why work for us?

Innovation. Act with Integrity. Collaboration. 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.

Zymeworks

Posted on: October 16, 2020

Closing: November 15, 2020

Salary($): Undisclosed

Position Type: Full Time

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Career Focus: Regulatory/Compliance

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