Reporting to the Vice President, International RA, the role of Director, Regulatory Affairs is responsible for leading the development and improvement of regulatory affairs capabilities, and enhancing and supporting the continuing improvement of performance, in Canada in accordance with BD Corporate requirements. This role will manage and oversee main regulatory activities in Canada by ensuring that country regulatory standards and requirements are adhered to for products destined for sale in the country markets, regardless of source of supply. This role will provide strategic guidance regarding the impact of regulatory issues on overall corporate strategy and operations for the country. They will serve as an active member of the country Leadership Team providing advice and expertise on issues related to regulatory.
Assuring products are cleared to market and assuring that country processes are in compliance with local regulations and laws.
Develop short- and long-term regulatory strategies:
Actively monitor regional market regulatory requirements; ensure communication of such regulatory requirements to the Business Units and continuously monitor the environment for regulatory changes;
Provide guidance and support to the Business Units to ensure that regulatory changes are addressed timely and efficiently;
Oversee product registrations in the country;
Oversee product portfolio and pipeline management for the country;
Support compliance with national or local regulations and standards, as appropriate;
Monitor the Global Regulatory Affairs Monitoring Initiative (GRAMI) database and proactively liaise with the Business Units to manage any potential impact resulting from regulatory changes;
Actively contribute to key strategic decisions impacting the development of global regulatory compliance policies, processes and procedures;
Influence regional regulations and standards development;
Actively participate in the ASR meetings and business leadership meetings to discuss recent developments and strategic plans.
Provide interpretation of existing and emerging regulations and make recommendations for changes in quality systems, policies or procedures.
Establish programs and policies for interface with regulatory authorities according to Corporate Policy in areas of:
Audit or regulatory letter responses
Recalls and field activities support as appropriate.
Lead the development of the team to support the on-going and progressive business needs including identifying and developing successors for critical positions.
Develop and coach department associates, evaluate resource needs as driven by business requirements
Provide official BD representation to Canadian regulatory agencies including Health Canada (as signing official)
Interface with Canadian and worldwide BD leaders to develop WW regulatory strategies for the corporation, resolve high level regulatory matters and expedite regulatory activities (i.e involving health risks and liability)
Education and Experience
University degree required in the Life Sciences or Engineering
Minimum of 8 years of experience leading and managing a regulatory affairs/quality department.
Demonstrated ability to achieve complex product approvals.
Demonstrated ability to develop innovative regulatory strategies resulting in reduced product development costs and/or best-in–class review times with regulatory authorities
Excellent written and oral communication and organizational, project management skills.
Experienced in all regulatory compliance aspects of the business: pre-market, commercial, post-market, and regulatory.
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Becton Dickinson is an Equal Opportunity Employer. We encourage applications from individuals with a wide range of abilities and provide an accessible candidate experience. In accordance with the Accessibility for Ontarians with Disabilities Act, 2005 and the Canadian Human Rights Act, Becton Dickinson will provide accommodations to applicants with disabilities throughout the recruitment, selection and/or assessment process. If selected to participate in the recruitment, selection and/or assessment process, please inform us of any accommodation(s) you require by contacting HR at 1-855-234-3577.
Primary Work Location
CAN Mississauga - Derry Road West