Nuclear Fuel Services Director of Regulatory Affairs in Kanata, Ontario
BWXT Medical Ltd. provides its customers, who conduct life-saving medical procedures for patients around the world, the benefit of decades of experience in the development, manufacturing, packaging and delivery of medical isotopes and radiopharmaceuticals. Headquartered in Kanata, Ontario, BWXT Medical Ltd. employs over 150 highly-skilled people in Kanata and Vancouver, British Columbia. BWXT Medical Ltd. is part of the BWXT nuclear power segment (NPG) of BWX Technologies, Inc.
We are recruiting for a Director, Regulatory Affairs for our facility in Ottawa, Ontario.
Job Description / Duties:
This is a leadership position responsible for the development and implementation of regulatory strategy and successful timely registration of drug and radiopharmaceutical products, active pharmaceutical ingredients and medical devices for global markets.
Must implement strategy for submissions for the business to ensure acceptability and expedient approval.
Must work cross functionally with internal and external stakeholders to ensure that required regulatory filing and licenses are obtained and maintained.
Job Qualifications / Requirements:
Supporting the strategic objectives of the company, leads the development and execution of the regulatory strategy to ensure registration and ongoing compliance with regulatory requirements for products developed and manufactured by the company, or in support of contract manufacturing requirements.
Establishes the regulatory filing strategy and requirements for products developed and/or manufactured by the company. Is able to establish credible regulatory timelines and ensure the leadership team and resources are available to support meeting the timeline.
Represents the regulatory group on product development teams and the core project team communicating regulatory requirements for product development.
Works collaboratively with the product development team lead and functional area representatives to provide strategic regulatory input to key development documents and study reports, as required, and ensures that key deliverables supporting regulatory strategy are provided in alignment with program timelines and management expectations.
Coordinates, oversees and prepares submissions to be filed with the Regulatory Authorities in multiple jurisdictions for radiopharmaceuticals, active pharmaceutical ingredients (APIs) and devices, both proprietary and in support of customer filings.
Ensures that new regulatory information is appropriately reviewed by subject matter experts, performs regulatory risk assessments as required, and communicates proposed program modifications and impact to the defined regulatory strategy to leadership. Ensures adequate training is prepared and delivered to the organization as a result of existing or new regulatory requirements to maintain organizational compliance.
Maintains direct liaison with government authorities on scientific issues during the review process as well as on any matter relating to the manufacture of products.
Seeks opportunities to participate in regulation development and implementation.
Maintains consistent oversight of deliverables and ensures issues are escalated when needed and encourages resolution at the appropriate level. Plays a key role in development and implementation of appropriate systems, processes and standards.
Ensures records are maintained, and ensures all new and renewal applications are filed as required.
Manages pharmacovigilance activities for the organization.
Is the primary host for audits carried out by regulatory agencies and may be the host or assist the host with customer audits.
Demonstrated ability to manage a regulatory recall, including concise and rapid decision making, managing implementation of the process and managing communication with regulatory authorities, and overseeing communication with customers.
Provides oversight for any planned advertising/marketing of regulated products ensuring compliance with all regulatory requirements.
Knowledge & Experience:
Normally an advanced University Degree in life sciences or a health care related discipline plus 10 to 12 years working experience. Several years’ experience in Regulatory Affairs or equivalent background.
Experience with radiopharmaceutical, active pharmaceutical ingredients or medical devices in quality assurance, quality control or manufacturing is an asset.
Experience working directly with the FDA on regulatory filings/strategy is required. Similar experience with Health Canada is an asset.
Experience with electronic submissions/the electronic submission process
Experience managing pharmacovigilance
Knowledge of how regulatory agencies operate, structure and process
BWXT Medical Ltd. embraces diversity of thought, values individuality, encourages new perspectives and provides equal opportunity in employment for all qualified employees and applicants without regard to race, national or ethnic origin, colour, religion, age, sex, sexual orientation, marital status, family status, disability, a conviction for which a pardon has been granted or a record suspended or any other category protected by federal law.