Regulatory Affairs, Project Manager

AstraZeneca - Mississauga, ON (30+ days ago)

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At AstraZeneca, we are united by a common purpose – to push the boundaries of science to deliver medicines. This purpose underpins everything we do; our work helps to make hearts healthier, to help people breathe easier, and to help more people survive cancer. Every day, we make a difference by delivering potentially life-changing medicines to millions of people worldwide and by leading breakthrough science that promises to transform the treatment of disease.

Our purpose is bold and so is our approach. Becoming a more agile and innovative company means creating a vibrant, dynamic culture where we celebrate entrepreneurial thinking and act with a sense of urgency. We are courageous, taking risks and learning from both success and failure. We are curious, creative, and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us and be part of a great place to work; an environment that energizes and empowers each of us to contribute to achieving our goal to develop and deliver life-changing medicines.

Position Type: Permanent, Full time

Location: Mississauga, Head Office

Career Level: D

Are you detail oriented with experience in Clinical Trials and Regulatory Compliance? Are you motivated to solve puzzles and improve processes? Do you love detailed work?

As an integral part of the regulatory team you will manage Clinical Trial Applications (CTAs), build regulatory strategies and maintain compliance with AZ corporate policies.

Responsibilities:
Lead all activities related to optimal (timely and quality) delivery and maintenance of CTAs, Amendments and Notifications (including supporting of Externally-Sponsored Studies and CROs with filings and Health Canada review process) aligned to Health Canada and company requirements.
Responsible for preparation, publication, review and quality control and delivery of all CTA and related submissions. You will critically assess all CTAs and submissions prepared by AZ regulatory professionals to ensure compliance to the requirements from regulatory agencies and AZ standards. Interpret and ensure all formatting, standards and operating procedure requirements, including compliance with electronic Trial Master File system.
Manage and support the submission review process (eg, responding to clarifaxes).
Provide regulatory input and direction to the Canadian Cross Functional Team and Global Clinical and Regulatory teams to build strategies, deliver optimal Health Canada approvals (time and quality), maintain compliance and positively impact clinical trials’ and products’ potential and lifecycle in the Canadian marketplace. You actively support the team to maximize efficiency, performance and productivity.
Build and implement regulatory strategic plans including Regulatory Strategy Documents for novel trials with registration intent (as required).
Prepare for and lead pre-CTA meetings with Health Canada contacts. Work with Key External Experts for meetings, participate in Health Canada advisory boards and author summary for Health Canada submission.
Prepare, submit and negotiate approvals of other regulatory submissions as assigned.
Maintain regulatory compliance of approved products as assigned.
Influence the global development of clinical trials and products, representing the Canadian market, to mitigate regulatory risks in the development plans.
Lead or participate in cross-functional and external initiatives.
Ensure regulatory submissions and documents are aligned with both HPFB and AZ requirements and standards (e.g., Electronic submission processes).
Provide comments on emerging Canadian regulations/policies/guidelines/initiatives/surveys.
Provide expertise and support to junior staff members (associates, students and assistants) to positively encourage development and knowledge transfer.

Qualifications:
B.Sc. or equivalent in a related (health science) discipline; advanced degree (M.Sc. or Ph.D.) is an asset
Strong knowledge of the Canadian regulatory environment and Canadian regulations, policies and guidelines
Strong experience with clinical trials and regulatory applications in one or more of the following key therapeutic areas Cardiovascular, Renal and Metabolism, Oncology, Respiratory/Inflammation and Infection is ideal
Minimum 3-5 years regulatory experience in the brand name pharmaceutical or biotechnology industries
Minimum 2 years regulatory project management experience
Proficient in the use of MS Office
Superior negotiation skills, problem solving ability and innovative creative thinking
Excellent time management and organizational skills (able to handle multiple projects and priorities effectively)
Keen detail orientation to identify errors
Strong written and verbal communication skills
Ability to identify risk and build a plan to mitigate the risk
Positive interpersonal and relationship building skills with the ability to work effectively in a team both internally and externally

Great People want to Work with us! Find out why:
GTAA Top Employer Award for 6 years: https://reviews.canadastop100.com/top-employer-astrazeneca-canada
Best Workplace Culture Award at the 2018 Canadian HR Awards: https://www.linkedin.com/pulse/thriving-best-workplace-culture-gena-restivo/
Learn more about our culture: https://www.linkedin.com/posts/genarestivo_greatpeople-greatplacetowork-topemployers2020-activity-6608742174811049985-N-8G

Are you interested in working at AZ? Apply today!