Manager, Regulatory Affairs

Job title: Manager, Regulatory Affairs

Company: Bayer

Job description: Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change

Manager, Regulatory Affairs

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Manager, Regulatory Affairs, are to:

The Regulatory Affairs Department within the Pharma 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.

Reporting to the VP and Head of Regulatory Affairs, the Regulatory Affairs Manager leads the development, execution; in addition to, supervision of regulatory strategies and complex regulatory applications in order to successfully achieve and maintain registrations in compliance with all Canadian regulatory requirements. The Manager is responsible for managing a portfolio of brands within their assigned therapeutic areas (Hematology, Immunology and Thrombosis) and manages direct report(s) to meet the needs of the Regulatory Affairs Department. The position would also lead the strategic management of external stakeholders along with building a strong working relationship with local and global functions in the management of regulatory activities.

As a member of the Regulatory Affairs Leadership Team, assists the VP and Head, Regulatory Affairs, in establishing objectives and direction for the Regulatory Affairs Department, including fostering a high-performance work culture.

Key Tasks:

• Responsible for independently managing all regulatory activities within their assigned therapeutic areas (Hematology, Immunology and Thrombosis) in addition to providing supervision and coaching of direct report(s).
• Provide leadership in creating a high-performance culture: developing, coaching, mentoring and managing direct report(s) to maximize employee engagement and professional growth.
• Lead the development and exploration of efficient and effective or innovative submission strategies including carefully assessing and summarizing scientific, clinical and other technical information.
• Independently drives the preparation of high-quality submissions and executes or supervises the timely execution of 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).
• Lead new product development or portfolio and therapeutic area pipeline activities including leadership of New Drug Submissions and support new product launches.
• Supervise and ensure implementation of labeling changes and quality change management activities in cooperation with local and global functions.
• Lead interactions and enhance the relationship with Health Canada and other external stakeholders including Health Canada meetings and negotiating the approval of regulatory key submission / activities.
• Be a valued strategic partner in cross-functional teams with internal partners locally and globally; lead strategic input in the development of product/portfolio strategies and developing solutions to issues.
• Provide impact / assessments regarding changes in CMC or clinical drug development.
• Review / approve and drive strategic input into promotional material and product labeling for regulatory requirements.
• Lead and directly develop departmental procedures and processes to ensure compliance with the Food & Drugs Act, Health Canada Regulations, and other applicable industry standards. Ensure team compliance to global quality systems.

WHO YOU ARE

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:

• B.Sc. (required) or M.Sc. (preferred) in Pharmacy, Pharmacology, Chemistry, Biological Sciences, or equivalent.
• Excellent working knowledge of Food and Drugs Act and Regulations.
• Minimum 5 years progressive experience in Regulatory Affairs.
• Direct management / supervisory experience of staff.
• Experience in one or more of the following therapeutic areas is an asset: Hematology, Immunology, Cardiology.
• Experience leading a major Regulatory submission and cross-functional team.
• Extensive knowledge of drug development (clinical studies, chemistry and manufacturing etc.) in the healthcare industry.
• Strong analytical skills with the ability to assess scientific data.
• Strong computer skills; excellent written, verbal, and organization skills.
• Proven communication and negotiation skills.
• Ability to build and maintain strong and collaborative working relationships with internal and external contacts.

Referral candidates should not apply directly to this job posting. All referral candidates must first be submitted within our ATS by a current Bayer employee.

#LI-CA

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.

Location:

Canada : Ontario : Mississauga

Division:

Pharmaceuticals

Reference Code:

406865

Expected salary:

Location: Mississauga, ON

Job date: Fri, 14 May 2021 04:22:48 GMT