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Sr Regulatory Affairs Associate - Contract

The Regulatory Affairs Department within the Pharmaceutical (PH) Division is primarily concerned with the registration of new products and compliance of existing products according to Federal and/or Provincial Regulations. The department identifies solutions that are in line with commercial objectives and resolve issues that would affect the business operations and for patients.

Bayer Inc.'s PH Division is undergoing a major transformation in our operating model and customer engagement approach to better serve our patients and customers and achieve 'Health for All.' Reporting directly to the Head of Regulatory Affairs PH, the Senior Regulatory Affairs Associate (RAA) position would be a strong contributor to regulatory strategies and would execute regulatory activities in order to successfully achieve and maintain clinical trial and drug / device registrations in compliance with all Canadian regulatory requirements. The Senior RAA is responsible for managing assigned products to meet the needs of the Regulatory Affairs Department including executing complex regulatory applications. The position would also directly engage external stakeholders along with fostering a close working relationship with local and global functions in the management of regulatory activities.

Bayer is committed to a flexible hybrid working environment. This is a 14-month contract position based out of Mississauga, ON

What you will do:

• 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, CTAs, 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 Health Canada primarily regarding application regulatory submission activities. Participation as needed in industry association activities.
• Contribute to the management and conduct of Health Canada 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, e.g. 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 you are:

• B.Sc. (required) or MSc (preferred) in Pharmacy, Pharmacology, Chemistry, Biological Sciences, or equivalent.
• 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.
• Experience working across multiple Therapeutic Areas.
• Strong analytical skills with the ability to assess scientific data.
• Strong computer skills; Excellent written, verbal, organization and proven negotiation skills.
• Demonstrates, credibly embodies and role models Visionary, Architect, Coaching and Catalyst (VACC) capabilities.
• Continually seeks feedback from peers to improve business outcomes and able to set and deliver against 90-day and long-term goals to achieve desired impact/outcome.
• Bilingualism would be an asset (French & English).
  
  

What we offer:

• Competitive compensation and rewards package.
• Collaborative, diverse and inclusive culture.
• Career development and global opportunities.
• Work-life flexibility programs such as flex hours, employee discounts, volunteer days, wellness, and other employee offerings.

Bayer is committed to fostering, cultivating and preserving a culture of Inclusion and Diversity. We embrace and encourage our employees' differences and believe that our people are our most valuable asset. The collective sum of individual life experiences, knowledge, innovation, self-expression, unique capabilities that our employees invest in their work represents our culture, reputation, and Bayer's values and purpose.

All referral candidates must first be submitted via our internal referral system by a current Bayer employee in order to participate in the referral program. Once a Bayer employee has successfully referred you in our system, you will receive an automated email with instructions on how to complete your application.

This posting will be available for application until at least July 28, 2025.

#LI-CA

Bayerwelcomes and encourages applications from people with disabilities. Candidates participating in ourselection 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 bemade.

Location:

Mississauga

Division:

Pharmaceuticals

Reference Code:

848726

To apply please click on APPLY TO THIS POSITION