Regulatory Affairs Project Manager

5 months ago

Mississauga, Canada AstraZeneca Full time

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.

**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.

Regulatory Affairs Project Managers provide regulatory input and direction to the Canadian Cross Functional Team and Global regulatory teams to build regulatory strategies, prepare and deliver optimal Health Canada approvals (time and quality), maintain compliance and positively impact a product's potential and lifecycle in the Canadian marketplace.

**What you’ll do**:

- Regulatory Affairs lead for one or more growth brands
- Member of Brand/Lifecycle teams(s)
- Preparation, submission and negotiation of approvals of NDSs and Clinical SNDSs, ensuring alignment with both HPFB and AstraZeneca requirements and standards
- Maintain regulatory compliance of approved products
- Build and implement regulatory strategic plans including Regulatory Strategy Documents
- Investigate and execute on accelerated regulatory review pathways to address areas of unmet need
- Plan and conduct Health Canada meetings for the purpose of scientific exchange and pre-submission planning
- Provide strategic and informed regulatory/business expertise across the organization as required
- Influence the global development of products, representing the Canadian market, to mitigate regulatory risks in the development plans
- Work with external experts and participate in key external advisory boards to enhance understanding of Canadian clinical practice and clinical relevance of emerging data
- Build and release Health Professional and Public Communications
- Review and approve promotional materials including artwork
- Compile responses to ATI and PRCI requests
- 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
- Knowledge of one or more of the following key therapeutic areas Cardiovascular-Metabolism, Oncology, Respiratory/Immunology is an asset
- Minimum 3-5 years regulatory clinical experience in the brand name pharmaceutical or biotechnology industries
- Minimum 2 years regulatory project management or related 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
- Superior negotiation skills
- 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
- Strong written and verbal presentation skills and adept at crafting business proposals and project plans

Great People want to Work with us Find out why:

- GTAA Top Employer Award for 9 years
- Learn about our culture
- Learn more about working with us in Canada
- View our YouTube channel

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