Cmc Regulatory Affairs Director and Team Manager

2 months ago

Mississauga, Canada AstraZeneca Full time

**Job Title**: CMC Regulatory Affairs Director and Team Manager Submission Excellence & Project Management
**Location**: Mississauga, ON

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.

**Introduction to Role**:
Join us at AstraZeneca as a Regulatory Affairs Director (Submission Excellence) Line Manager. This strategic leadership role is accountable for leading a team of Regulatory professionals, providing overall direction, and ensuring the delivery of global CMC regulatory submissions for a product/group of products across the product lifecycle. This role is integral to our biologics Respiratory and Inflammation portfolio within our Biopharm R&D business area, where you'll play a key part in gaining approval for new products, as well as new indications, post approval variations and maintenance activities for existing products with important and unmet medical needs.

**Accountabilities**:
As a Regulatory Affairs Director, you will provide overall direction, develop and line manage a group of regulatory CMC experts within the CMC RA organisation. You will be accountable for recruitment, skill-development, coaching, and performance feedback of team members. You will ensure project activities managed within the team are delivered to a high standard, agreed time scales and meet the AZ business requirements, compliance requirements and regulatory authority expectations worldwide. You will also lead cross SET non-drug projects and act as business owner for critical business processes to ensure accelerated submissions, support launch activities and management of regulatory information and ensure regulatory compliance on behalf of AZ.

**Essential Skills/Experience**:

- Bachelors degree in Science, Regulatory Sciences or Pharmacy.
- 7 years experience in Regulatory/Drug development (Industry or Health Authority)
- Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs
- Proven leadership and program management experience.
- Proven track record of independently manage complex managerial tasks
- Proven track record of coaching and delegation capabilities
- Ability to think strategically and critically evaluate risks to regulatory activities.
- Ability to work strategically within a complex, business critical and high profile development program.
- Must demonstrate competencies of: strategic thinking, strategic influencing, innovation, initiative, leadership, decision making and excellent oral and written communication skills.
- Experience of people management.

**Desirable Skills/Experience**:

- Masters degree or PhD in Science, Regulatory Sciences or Pharmacy.
- 10 years experience in Regulatory/Drug development (Industry or Health Authority)

At AstraZeneca, we are driven by innovation and originality. We work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We are all compassionate team players and driven achievers, always ready to step up. We see change as an opportunity, embracing the possibility to learn, grow and evolve. We are striving for technology adoption and automation to drive efficiencies and new innovations. Here we have the ability and autonomy to be an agent of change.

**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

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