Senior Regulatory Affairs Associate
Your tasks and responsibilities
The primary responsibilities of this role, Senior Regulatory Affairs Associate, are to:
- Responsible for managing assigned products and projects.
- Strongly contribute to the development and broad exploration of efficient and effective or innovative submission strategies including carefully assessing and summarizing scientific, clinical and other technical information.
- Manage the preparation of high quality submissions and execute complex regulatory submission strategies for new product and clinical trial registrations or to ensure continual regulatory compliance for product related changes (including Notifiable Changes, SNDS, medical device license applications, CTA-As, CTA-Ns, as applicable).
- Implement labeling changes and quality change management activities in cooperation with local and global functions.
- Build and maintain interactions through direct engagement with Canadian Health Authorities and other external stakeholders. As directed, communicate effectively with Federal and Provincial Regulatory Authorities primarily regarding regulatory submission activities. Participation as needed in industry association activities.
- Contribute to the management and conduct of Health Authority meetings during the drug development and filing processes.
- Collaborate with local and global partners on cross-functional teams by providing regulatory input towards the development and review of product strategies, and solutions to product-related issues.
- Provide impact / assessments regarding changes in CMC or clinical drug development.
- Review clinical trial product labelling and labelling materials for marketed products to ensure corporate and regulatory compliance.
- Perform other Regulatory Affairs duties as required, potentially across specific Therapeutic Areas, eg collaborate with Medical Information group to develop standard responses.
- Review and approve promotional material and product labeling for regulatory requirements. Perform submissions to pre-clearance agencies as required.
- Develop or maintain departmental procedures and processes to ensure compliance with the Food & Drugs Act, Health Canada Regulations, and other applicable industry standards. Maintain compliance to global quality system needs.
Who are you
Your success will be driven by your demonstrations of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possess the following:
Who you are
- B.Sc. (required) or M.Sc (preferred)
- Knowledge of Food and Drugs Act and Regulations.
- Candidates must have demonstrated success in a regulatory environment (e.g. experience leading a Regulatory submission team), and knowledge of drug development (clinical studies, chemistry and manufacturing etc.) in the healthcare industry.
- Minimum 2 years in Regulatory Affairs
- Strong analytical skills with the ability to assess scientific data.
- Strong computer skills; Excellent written, verbal, organization and proven negotiation skills.
Bayer welcomes and encourages applications from people with disabilities. Candidates participating in our selection process requiring accommodation due to a disability or medical need are encouraged to notify the Bayer representative that they will be meeting with to ensure appropriate arrangements can be made.
Functional Area: [sap_fa_32]
Entry Level: 5