Job Description

Prepares/executes global/regional regulatory tactical submission plans on allocated projects/products that implement the agreed regulatory strategy to develop and maintain products. Generates/project manages delivery, to time/quality of submissions. Demonstrates in depth knowledge of Regulatory compliances and submissions. Develops and builds good relationships with internal customers and Regulatory authorities, improving Regulatory outcomes.

Typical Accountabilities

Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance.

Provide regulatory input and direction to Brand and Global regulatory teams in order to deliver regulatory strategies, optimal Health Canada approvals (time and quality), maintain compliance and maximize a product’s potential and lifecycle in the Canadian marketplace.

Specific Responsibilities of Role Holder

In addition to the general description of the parent profile role for this job function, the following summarize key result areas, specific accountabilities and / or tasks, etc. associated with this job title include:

• Lead the development and implementation of regulatory strategic plans including Regulatory Strategy Documents

• Assess, prepare, submit and negotiate approvals for regulatory submissions with optimal outcome in line with cost recovery, business and regulatory requirements

• Maintain regulatory compliance of approved products

• Plan and execute Health Canada meetings including preparation of Key External Experts and Global/Local cross-functional teams

• Develop and finalize Health Professional/Public Communications as required

• Review and approve promotional materials and external communications

• Compile or coordinate responses to transparency requests (e.g. ATI, PRCI)

• Initiate and support artwork activities

• Support clinical trial applications as required

• Provide strategic and decisive regulatory/business expertise to Brand/Launch Teams and across the organization

• Influence the global development of products, representing Canadian regulatory environment and market, to mitigate regulatory risks in the development plans (as applicable)

• Ensure regulatory submissions and documents are compliant with both HPFB and AZ requirements and standards (e.g., electronic submission processes)

• Provide comments and stay abreast on emerging Canadian regulations/policies/guidelines/initiatives/surveys

• Actively create and promote collaboration with AstraZeneca Canada, Global Regulatory Affairs, Key External Experts and Health Canada to identify and act on opportunities combining forethought with action

• Actively support the RA department to maximize collaboration, efficiency, performance and productivity

• Provide guidance and support to junior staff members (associates, students)

• Adhere to principles of Good Regulatory Practice.

• Complete mandatory training in Cornerstone within specified timeframe.

Education, Qualifications, Skills and Experience

Essential

• University degree or equivalent in a related (health science) discipline

• Minimum 3-5 years regulatory experience in the brand name pharmaceutical/biotechnology industries

• Negotiation skills

• Excellent project management, time management and organizational skills (ability to manage multiple projects and priorities effectively)

• Excellent written and verbal communication skills

• Risk identification and management

• Interpersonal and relationship-building skills

• Ability to participate in collaborative teamwork

• Detail oriented

• Problem solving ability and innovative strategic thinking

• Strong knowledge and understanding of the Canadian regulatory environment and Health Canada regulations, policies and guidelines

• Proficient in the use of MS Office

• Customer-focused

Desirable

• Advanced university degree (MSc or PhD) considered an asset

• Therapeutic/functional area, product and brand knowledge

• Knowledge of competitor products

• In depth, cross-functional strategic knowledge (Commercial, Market Access, Medical, Operations)

• Ability to take calculated risks

• Knowledge of international regulatory activities and trends

• Knowledge of AstraZeneca global and local policies and procedures

• Presentation skills

• Business acumen, such as writing business proposals and project plans

WHY JOIN US?

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.

Help to shape our journey towards becoming a tech-enabled enterprise. Encouraged to look to the future, think strategically and innovate, we influence progress today. We are constantly introducing new solutions and technology through on our quest to grow through innovation. We love it here because put simply, we make a meaningful impact.

Technology at AstraZeneca is a home for purposeful disruptors. Apply now to learn more about this exciting opportunity with a world-renowned pharmaceutical brand!

SO, WHAT’S NEXT?

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

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 is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

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.

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Date Posted

Closing Date

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.