Regulatory Affairs Project Manager, CMC/TA

Hiring By - Biostaffic

 BioPharma

Canada

Job Highlights

Not Disclosed

Associate

Posted 4 months ago
Job details
At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.
Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.
About the role:
The Regulatory Affairs Project Manager, CMC/TA is a hybrid role working in both the CMC and Therapeutic Area functions. This role will provide leadership and/or support on regulatory CMC and Therapeutic Area (non-CMC including clinical, non-clinical and labelling) matters to deliver optimal Health Canada approvals (time and quality), maintain compliance, and maximise a product’s potential and lifecycle in the Canadian marketplace. Actively support the Regulatory Affairs department to maximize efficiency, performance and productivity. Role holder has an excellent understanding of current regulatory requirements.
Responsibilities:
  • Lead and/or assist in the development and implementation of:
    • Therapeutic Area, CMC and Establishment License (EL) submissions and strategies which will facilitate the submission review process with an aim to deliver optimal Health Canada approvals in support of business objectives.
    • regulatory strategic plans including Regulatory Strategy Documents.
  • Review therapeutic area, chemistry and manufacturing documentation for compliance vs AZ standards and Health Canada regulations. Convey recommendations to management.
  • Plan and execute Health Canada meetings including preparation of Key External Experts and Global/Local cross-functional teams.
  • Prepare and submit regulatory files (NDSs, SNDSs, NCs, NSNs, Level Changes) in adherence with the Food and Drugs Regulations and Medical Device Regulations, as appropriate, for submission to the Pharmaceutical Drugs Directorate (PDD), Biologics and Radiopharmaceutical Drugs Directorate (BRDD), and Health Products and Food Branch Inspectorate (HPFBI), Health Canada.
  • Facilitate submission approvals through effective discussions and communication with PDD, BRDD, and HPFBI.
  • Review and approve promotional materials and external communications.
  • Maintain registration compliance for assigned projects to support ongoing manufacture and/or marketing of products in Canada.
  • Develop, foster and maintain positive relationships with all stakeholders involved in the lifecycle management of our brands.
  • Help monitor changes to Regulatory environment (regulations, guidelines, policies, etc.) as directed by Manager.
  • Conduct activities and interactions consistent with our values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role.
  • Perform other regulatory activities as directed by Manager.
Essential:
  • B.Sc. or equivalent in a related (chemistry, health science) field. Advanced degree (M.Sc., PhD) considered an asset as well as experience with synthetic drug products, biologics and Establishment Licenses.
  • Previous experience in Regulatory Affairs required.
  • Current knowledge of cGMP, Health Canada regulations and ICH guidelines.
  • Excellent project management, time management and organizational skills. Able to balance and progress multiple projects across CMC/therapeutic areas.
  • Excellent communication skills, both written and verbal.
  • Proficient in the use of Microsoft Office and Veeva Vault applications.
  • Problem-solving ability and innovative thinking.
  • Well developed negotiation skills.
  • Attention to detail, balanced with understanding of business objectives.
Desirable:
  • Cardiovascular, Renal and Metabolism therapeutic area, product and brand knowledge
  • Knowledge of local and international regulatory activities and trends
Great People want to Work with us! Find out why:
  • GTAA Top Employer Award for 10 years
  • Top 100 Employers Award
  • Canada’s Most Admired Corporate Culture
  • Learn more about working with us in Canada
  • View our YouTube channel
Are you interested in working at AZ, apply today!
AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • Canada

Experience:

  • Associate

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 12, 2024
Company Overview
AstraZeneca
AstraZeneca

Current Openings: 0

We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. For more information, visit www.astrazeneca.com. Community Guidelines: bit.ly/2MgAcio
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