Regulatory Affairs Manager

Bimeda • Cambridge, ON

82d

About The Position

The Regulatory Affairs Manager is responsible to lead new product registration and post-approval lifecycle management for veterinary pharmaceuticals for the USA (FDA-Center for Veterinary Medicine (CVM)) and Canada (Health Canada – Veterinary Drugs Directorate VDD)). This individual works cross-functionally to develop and implement regulatory strategy, support regulatory compliance, and act as a liaison between Regulatory Affairs and other functional areas such as R&D, QA, Supply Chain and Manufacturing. This position manages the Regulatory Affairs team.
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.

Requirements

• 10 years pharmaceutical experience with 5 years in leadership role
• BSc degree in science / life sciences
• 5 years of experience in Regulatory Affairs
• Strong working knowledge of regulations and ability to interpret policies and guidelines
• Ability to build and maintain strong and collaborative working relationships with internal and external business partners
• Good time management and organizational skills
• Ability to motivate and lead a regulatory affairs team

Nice To Haves

• Masters degree or Regulatory Affairs Certification
• Project management tools

Responsibilities

• Provides leadership and strategic thinking in preparation and compilation of new product registration submissions to FDA-CVM and VDD for sterile injectable and oral paste products.
• Communicates issues, risks, and current and emerging regulatory requirements and /or trends to Senior Management and offers solutions to mitigate/solve problems.
• Establishes and maintains good working rapport with key staff at the Veterinary Drugs Directorate (VDD).
• Manages assessment, submission strategy and regulatory compliance aspects of lifecycle management/post-approval changes to marketed drugs, as well as annual and compliance reporting requirements.
• Represents Bimeda externally in industry trade associations, customer and supplier meetings and networking events as needed to further Bimeda’s interests.
• Responsible for the site’s FDA-CVM Type V Veterinary Master File for aseptic processing as well as Canada Drug Establishment License.
• Works with R&D personnel to produce required documentation and information for new product submissions.
• Works with the larger Bimeda network to facilitate preparation of marketing applications and post approval submission documents for export markets.
• Represents Regulatory Affairs on cross-functional teams to provide scientific and regulatory support as needed.
• Develops direct reports by coaching, motivating, and training to foster continued growth and continuous improvement in operations.
• Works cross-functionally in assessing the impact and regulatory risk of proposed product and facility changes with respect to regulatory requirements and compliance.
• Ensures that company policies are followed with respect to hiring, terminations, performance reviews, and submission of proposed salary adjustments.
• Sets performance goals and objectives with direct reports.
• Provides support for facility audits by FDA and Health Canada. Participate in responses and corrective actions to any observations as required.

Benefits

• Competitive salary.
• 13 paid holidays.
• Competitive vacation policy effective upon hire.
• 5 paid personal care days.
• Employee Assistance Program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level