At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.

Regulatory Affairs Director

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 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'. The Regulatory Affairs Director is a senior Regulatory Affairs role that reports to the Head of Regulatory Affairs PH.

The Regulatory Affairs Director is a key regulatory leadership position which is concerned with maximizing and protecting the commercial interests of Bayer. It is a key strategic position directly impacting and overseeing regulatory approvals, product labelling and compliance with Federal regulations within the PH Division.

Bayer is committed to a flexible hybrid working environment. This is a permanent position based out of Mississauga, Ontario.

What you will do:

• Lead strategy development for a breadth of products and therapeutic areas to deliver best-in-class regulatory approvals.
• Function as Canadian regulatory expert on local/global Product Squads and cross-functional teams, influence global strategy, and provide guidance on current Canadian regulatory requirements.
• Coach, mentor and provide strategic guidance to Regulatory Affairs professionals in the preparation, negotiation and finalization of high quality and timely regulatory approvals within assigned therapeutic areas. Accountable for ensuring applicable Health Canada guidelines are followed.
• Manage therapeutic area project prioritization and resource allocation.
• Provide leadership in creating a high-performance culture: developing, coaching, and mentoring members of the RA Team to maximize employee engagement and professional growth.
  
• Guide and enable the new ways of working including local market driven business planning, 90-day missions, shared objectives and accountability, dynamic ownership, and continuous improvement.
• Responsible for the development and maintenance of excellent working relationships with Health Canada and Industry Associations, fostering Bayer's external reputation based on integrity. Lead and oversee Health Authority interactions / meetings including liaison with Health Canada management and understand emerging trends and issues.
• Drive internal processes and decision making for assigned products (e.g. local licensing and life-cycle management activities, Thought Leader development, brand planning) to ensure that Canadian regulatory needs are incorporated into launch and growth strategies to optimize revenue and profit and to ensure regulatory compliance and efficiency.
• Oversee or lead the development or maintenance of departmental procedures and processes to ensure compliance with the Food & Drugs Act, Health Canada Regulations, and other applicable industry standards, in addition to efficiency improvements.
• Identify major clinical, technical or operational risks impacting on the success of filing, approvals, labelling and maintenance. Develop proactive regulatory strategies to mitigate risks.
• Provide strategic input into and oversee Canadian representation on Global Regulatory Strategy teams.

• Lead and provide strategic oversight of other Regulatory Affairs duties as required, within Pharma, for strategic advisement of internal stakeholders (e.g. marketing / sales groups) regarding the advertising and promotion of products within the Canadian Regulatory Environment to optimize and ensure competitiveness of product communications.
  
• Perform regulatory due diligence, proactively identify risks and opportunities in the regulatory environment and assess business impact and advise business partners accordingly.
• Responsible for stakeholder relationship management with Thought Leaders. Provide regulatory leadership in meetings with Thought Leaders or external experts as necessary to contribute to business initiatives and/or integrate Thought Leader insights /participation into regulatory strategy.

Who you are:

• University degree in Pharmacy, Pharmacology, Chemistry, Biological Sciences, or equivalent preferred.
• PhD with a minimum of 8 years of experience in pharmaceutical industry/area OR Master's Degree with a minimum of 10 years of experience in pharmaceutical industry/area OR Bachelor's Degree with a minimum of 12 years of experience in pharmaceutical industry/area.
• Experience in working across multiple therapeutic areas, including Oncology.
• Experience with direct Regulatory Agency contact (lead major strategic initiative, e.g. NDS).
• High level of impact and influence competencies.
• Advanced knowledge/expertise of the Food & Drugs Act and Food and Drug Regulations.
• Strong analytical skills with the ability to assess cross-function information with experience in risk assessment and risk management, together with sound business judgment.
• Proficient computer skills, including all MS Office applications.
• Proven leadership, influence/negotiation, management and facilitation/presentation and communication skills with results-oriented team building capability. Experience leading and mentoring individuals/teams towards achieving business objectives.
• Demonstrates, credibly embodies and role models Visionary, Architect, Coaching and Catalyst (VACC) capabilities.
• Proven track record of strategic thinking and execution.
• Exceptional interpersonal and communication skills- ability to effectively interface with senior level internal and external stakeholders to drive towards common objectives.
• Ability to build and maintain strong and collaborative working relationships with internal and external contacts and be a change agent.
• Proven ability to work independently and under pressure on multiple projects.
• Demonstrated success in a regulatory environment (e.g. leading major submissions), and extensive knowledge of drug development (clinical studies, chemistry and manufacturing etc.) in the healthcare industry.
• 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:

849118

To apply please click on APPLY TO THIS POSITION