Job Title: Regulatory Affairs Manager
Location: Cambridge, ON
Position Type: Full-time regular

Shift: Day Shift, Monday - Friday
Vacancy Status: This role is currently vacant
AI Disclosure in Hiring: We do not use artificial intelligence to screen, assess, or select applicants

Role Summary

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.

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. Participate 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 - is the ability of an individual 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. Provide motivational support, and the ability to develop and communicate goals in support of the business mission. Provides direction with purpose and alignment to Company vision and values.

• ADAPTABILITY/CHANGE AGILITY - Is the ability to be agile and adapt to constant change; shows good resistance to pressure and stress; is resilient and open-minded. The ability to demonstrate support for innovation and for organizational changes needed to improve the organization's effectiveness; initiating, sponsoring, and implementing organizational change. The ability to change or be changed in order to fit or work better on some situation or purpose and embraces change. Strives for continuous improvement.

• CUSTOMER ORIENTATION - The ability to demonstrate concern for satisfying one's external or internal customers. Identifies and prioritizes customer needs and recognizes constraints. Seeks to find out more about customers and provide better service. Is professional, reliable and delivers on promises. Brings a competitive focus to customer.
• EFFECTIVE COMMUNICATION - Is the ability to convey information to another effectively and efficiently, to listen - help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts whilst adapting to one's audience. Exhibit willingness to listen and show respect for oneself and others in interactions with others. express oneself clearly in verbal and business writing.
• FOSTERING COLLABORATION/TEAMWORK- is 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; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance. Respects others.

Other Requirements

Essential:

• 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

Desirable:

• Masters degree or Regulatory Affairs Certification
• Project management tools

Compensation & Benefits:

• Competitive salary.
• 13 paid holidays.
• Competitive vacation policy effective upon hire.
• 5 paid personal care days.
• Employee Assistance Program.
• Expected Salary Range: $120k-$160k/Year