AstraZeneca Hiring for Regulatory Affairs Associate (2 Year Contract) at Mississauga, ON Full Time

Do you have expertise in, and passion for, Regulatory Affairs? 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: 2-year Contract, 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.

Regulatory Affairs Associates provide support in delivering optimal product labelling and product approvals (time and quality) for non-marketed and marketed drug products (including biologics) across all Therapeutic Areas while maintaining compliance and positively impacting a product’s potential and lifecycle in the Canadian marketplace.

What you’ll do:
Support all aspects of the product labelling/artwork management process and other labelling projects as assigned.

Undertake product labelling/packaging related change controls, complaints, deviations and investigations as required by Quality Assurance, Medical Information or others.

Prepare product labelling/packaging component change notices as required by Operations.

Prepare Annual Product Review (APR) reports for labelling/packaging changes as required by Quality Assurance.

Provide support to TA and CMC areas, as required:
Prepare, submit and support negotiations for approvals of post-market submissions, e.g. SNDS-Labelling, SNDS-Safety Updates, new Product Monograph template conversions, Plain Language Labelling

Maintain regulatory compliance of approved products (e.g. Annual Notifications, internal Level changes, post-approval commitments)

Assist with the submission review process with Health Canada (respond to clarifaxes)

Assist in implementing regulatory strategies and tactics

Assist with the preparation of Supplemental New Drug Submissions and New Drug Submissions

Support external company labelling requests (as required).

Support Regulatory Publishing requests (as required).

Monitor changes to Regulatory environment (labelling-related regulations, policies, guidelines, etc.) as required.

Participate in cross-functional initiatives and TA/product-specific research, as required.

Actively support the department to maximize efficiency, performance and productivity.

Adhere to principles of Good Regulatory Practice.

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

Essential for the role:
B.Sc. or equivalent in a related (health science) discipline or relevant work experience

Some working knowledge of the Canadian Regulatory environment or Regulatory experience in the brand name pharmaceutical/ biotechnology industries

Knowledge of Health Canada regulations, policies and guidelines

Minimum 2 years regulatory experience

Strong project management, time management and organization skills (ability to manage multiple project and priorities effectively)

Strong written and verbal communication skills

Strong attention to details

Customer focused

Ability to work effectively in a team

Proficient in the use of Microsoft Office

Your strengths include:
Positive interpersonal and relationship building skills with the ability to work effectively as part of a team

Experience with Good Manufacturing Practices (drug product manufacturing/packaging, change control management, etc)

Relationship management skills

Risk identification and management

Problem solving ability and strategic thinking

Negotiation skills

Knowledge of packaging design and product branding principles

Experience with electronic labelling systems (e.g. BLUE)

Graphics design capabilities

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.