Regulatory Affairs Group Director, Late CVRM Regulatory Affairs
About The Position
We are looking for a Regulatory Affairs Group Director (RAGD) for the Regulatory Affairs Management (RAM) group supporting the Cardiovascular, Renal and Metabolic Disease Areas. This group is part of Late CVRM Regulatory. As RAGD you will be part of the RAM leadership team, responsible for line management of 7-12 regulatory professional staff. You will contribute to the strategy, direction and efficient operation of the Regulatory TA organization as well as the RAM community. Provide regulatory expertise and oversight to ensure high quality drug project operational delivery and efficiency by the group. You will also work on a drug project in a RAM role or drive continuous improvement or change projects. Extensive regulatory affairs and drug development knowledge is critical, preferably with experience of leading major first wave submissions and leading complex regulatory procedures across projects/products. You will also possess strong leadership skills, have experience of developing teams, and excellent communication skills.
Requirements
- University Degree in Science or a related subject area
- Extensive regulatory affairs and drug development experience within the biopharmaceutical industry, or at a health authority
- Knowledge of regulatory requirements, procedures and legislation for drug development, throughout the product lifecycle
- Proven successful leadership and project management experience
- Excellent collaboration, teamwork, oral and written communication skills
- Strong influencing and negotiating skills.
Nice To Haves
- Experience of leading major first wave submissions
- Experience of leading complex regulatory procedures across projects/products
- Experience of developing teams
Responsibilities
- Provide leadership, coaching and line management for a group of Regulatory Affairs Managers based in Mississauga
- Ensure efficient, targeted recruitment for the group and lead talent and performance development activities
- Collaborate with the RAM leadership team to set the strategy for tactical delivery and efficiency for drug projects
- Lead development and continuous improvement of expert and/or process area and/or work on a drug project
- Establish and develop relationships with key partners, internally and externally
Benefits
- Opportunity to work across teams, functions and even the globe
- Individualized flexibility
- Balance personal and work commitments
- Strong culture of collaboration and teamwork
- Engaging face-to-face in our offices 3 days a week
- Commitment to sustainability
- Empowerment to push the boundaries of science
- Opportunity to challenge convention and unleash entrepreneurial spirit
- Embrace differences and take bold actions to drive change
- Commitment to lifelong learning, growth and development for all
- Inclusive and equitable environment
- Promise to help colleagues realize the full breadth of their potential
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What This Job Offers
Job Type
Full-time
Career Level
Manager
