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Associate Director, Regulatory Affairs - CMC

Company: IowaLifeScience
Location: Vancouver
Posted on: November 24, 2022

Job Description:

Associate Director, Regulatory Affairs - CMCWhy Work for Us?Innovation. Act with Integrity. Collaboration. Embrace Diversity. CareWe 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 DescriptionZymeworks 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 Associate Director, Regulatory Affairs-CMC will provide guidance to cross-functional teams on CMC regulatory strategy and regional regulatory requirements and will be a key interface between CMC subject matter experts (SMEs) and Regulatory Affairs/Operations. Key responsibilities will include development and submission strategies for CMC modules/updates, including manage dossiers in eCTD format, life cycle management; and generation of submission-ready content for the Quality/CMC sections of all clinical trial and marketing authorization applications.This position will report to our Executive Director in Regulatory Affairs and can be based in our offices in Vancouver BC or Remote (Canada).As a condition of employment, Zymeworks requires all employees to be fully vaccinated against Covid-19 and provide verification of such.Key Responsibilities

  • Manage planning, preparation and internal review of CMC documentation for Clinical Trial Applications/IMPDs, IND submissions and amendments, marketing applications, and other communications with regulatory authorities.
  • Attend project team meetings and provide CMC-related regulatory guidance to other functional areas, including Manufacturing, Quality, and Commercial Operations.
  • Coordinate, manage and lead CMC regulatory projects including management of timelines, and submission planning.
  • Manage preparation and internal review of Module 2 (QOS) and Module 3 documents in accordance with Common Technical Document (CTD) guidance and company standards.
  • Manage preparation of responses to Health Authority comments and questions pertaining to CMC issues.Qualifications and Education
    • Bachelor's degree in a scientific discipline is required, advanced degree (MS or PhD) is preferred.
    • 5-8 years of experience in regulatory affairs with a focus on CMC documentation and CMC lifecycle management within the pharmaceutical or biotechnology industry is a must; experience with monoclonal antibodies and/or antibody drug conjugates (ADCs) desired.
    • Experience in preparation and submission of CMC modules in eCTD format, including variations and supplements, in the US, EU and at least one international region (e.g., LATAM, APAC) is required.
    • Working knowledge of FDA, EMA and ICH CMC guidance documents and regulations as well as working knowledge of international (e.g., LATAM and APAC) CMC requirements for investigational and marketed products is required.How to ApplyNOTE 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.Zymeworks is an Equal Opportunity Employer

Keywords: IowaLifeScience, Vancouver , Associate Director, Regulatory Affairs - CMC, Executive , Vancouver, Washington

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