Regulatory Affairs Project Manager - Clinical Trials

Job Description

Regulatory Affairs Project Manager - Clinical Trials

Do you have expertise in, and passion for, Regulatory Affairs and Clinical Trials? Would you like to apply your expertise to impact the lives of patients in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

Position Type: Permanent, Full time

Location: Mississauga, Head Office

About AstraZeneca:

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

Headquartered in Mississauga, Ontario, we’ve been recognized as one of Greater Toronto Area’s Top Employers for 7 straight years. Our collaborative work environment fosters knowledge-sharing, decision-making, and entrepreneurial thinking. Our employees have the opportunity to work across teams, functions, and even the globe. With a commitment to sustainability, we’re working towards making a meaningful impact where society needs it — health. We know the health of people, the planet and our business are interconnected, each impacting the others.

Our dynamic culture truly sets us apart. We support our people every day, focusing on three priorities: employee growth & development, health & wellbeing, and cultivating a vibrant, engaged and energized workplace. Through practical tools, resources, inspiring learning opportunities, and health and wellness support, we are helping our people thrive at work and beyond.

Regulatory Affairs:

Be part of a global, winning team filled with the smartest minds. Our diversity is our strength, it reflects the variety of patients we serve. We strive to create a place where everyone is empowered to speak up and share ideas, and we welcome alternative perspectives to push our thinking further, together. As an integral part of the regulatory team your primary responsibility will be managing Clinical Trial Applications and related life-cycle submissions in line with Health Canada, local and global company requirements, policies and procedures.

What you’ll do:

• As primary area of responsibility manage all activities related to optimal (timely and quality) delivery and maintenance of Clinical Trial Applications (CTAs), Amendments and Notifications (including supporting of Externally-Sponsored Studies and CROs) in line with Health Canada and company requirements.
• Prepare, submit and resolve issues for approvals of CTAs and related life-cycle submissions.
• Lead and support the submission review process with Health Canada (eg, responding to clarifaxes).
• Critically assess all CTAs and related submissions prepared by other AZ regulatory professionals to ensure compliance to the requirements from regulatory agencies and AZ standards. Interpret and enforce all formatting, standards and operating procedure requirements, including compliance with electronic Trial Master File system.
• Provide regulatory input and direction to the Canadian Cross Functional Team and Global Clinical and Regulatory teams to build regulatory 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. Influence the global development of products and clinical trials, representing the Canadian market, to mitigate regulatory risks in the development plans.
• Represent Canada in the local Clinical Study Team.
• Build and implement regulatory strategic plans including Regulatory Strategy Documents for novel trials with registration intent (as required).
• Lead pre-CTA meetings with Health Canada (as required).
• Prepare, submit and negotiate approvals of other regulatory submissions as assigned.
• Maintain regulatory compliance of approved products as assigned.
• Lead or participate in cross-functional and external initiatives.
• Actively support the team to maximize efficiency, performance and productivity.
• 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 to positively encourage development and knowledge transfer.

Essential for the role:

• 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 Health Canada regulations, policies and guidelines
• Strong experience with clinical trials and regulatory applications in one or more of the following key therapeutic areas Cardiovascular-Metabolism, Oncology, Respiratory/Immunology is ideal
• Minimum 3-5 years regulatory clinical experience in the brand name pharmaceutical or biotechnology industries
• Minimum 2 years regulatory project management experience
• Proficient in the use of MS Office

Your strengths include:

• Positive interpersonal and relationship building skills with the ability to work effectively as part of a team
• Strong decision-making, strategic and innovative thinking capabilities
• Ability to identify and execute on opportunities and risks and problem solve
• Agility, excellent time management and organizational skills (able to manage multiple projects and priorities effectively)
• Keen attention to detail

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

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

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.