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Director Of Regulatory Affairs
Company | Nuclear Fuel Services |
Address | Kanata, Ontario, Canada |
Employment type | FULL_TIME |
Salary | |
Category | Defense and Space Manufacturing |
Expires | 2023-07-24 |
Posted at | 10 months ago |
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.
- Must work cross functionally with internal and external stakeholders to ensure that required regulatory filing and licenses are obtained and maintained.
- Must implement strategy for submissions for the business to ensure acceptability and expedient approval.
- 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.
- 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.
- Provides oversight for any planned advertising/marketing of regulated products ensuring compliance with all regulatory 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.
- 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.
- 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.
- Manages pharmacovigilance activities for the organization.
- 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.
- Experience with electronic submissions/the electronic submission process
- Experience managing pharmacovigilance
- 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.
- 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.
- Knowledge of how regulatory agencies operate, structure and process
- Competitive salaries.
- Company match pension plan.
- Comprehensive health and dental benefits.
- Work within the growing and exciting nuclear medicine industry as well as with highly skilled employees.
- Collaborative work environment… and so much more!
- Life insurance.
- Education Reimbursement Program.
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