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Regulatory Affairs Director
3 weeks ago
**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.
