Regulatory Affairs Manager in Cambridge

The Regulatory Affairs Manager is responsible for leading 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.

Key Role Specific Requirements:

• 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.
• Participates in responses and corrective actions to any observations as required.

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.

Competencies Required for the Role:

• LEADERSHIP: The ability to influence, coach or inspire followers or other members of the organization; to enhance others’ commitment to their work and to a high-performance culture.
• ADAPTABILITY/CHANGE AGILITY: The ability to be agile and adapt to constant change; shows good resistance to pressure and stress; is resilient and open-minded.
• CUSTOMER ORIENTATION: The ability to demonstrate concern for satisfying one’s external or internal customers.
• EFFECTIVE COMMUNICATION: The ability to convey information effectively and efficiently, to listen and facilitate sharing of information between people.
• FOSTERING COLLABORATION/TEAMWORK: The ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team.

Other Requirements:

• 10 years pharmaceutical experience with 5 years in a leadership role.
• 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.
• Masters degree or Regulatory Affairs Certification.
• Project management tools.

About Bimeda: Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimise the health, wellbeing and productivity of the world’s animals.

Equal Opportunity & Accessibility: At Bimeda we are committed to fostering an inclusive, barrier-free and accessible environment. We are an equal-opportunity employer and assess candidates based on skills and experience.