Nuclear Fuel Services Regulatory Affairs Associate 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 Regulatory Affairs Associate for our facility in Ottawa, Ontario.
Coordinate, Oversee, and prepare submissions to be filed with Regulatory Authorities in multiple jurisdictions for radiopharmaceuticals, Active Pharmaceutical Ingredients, and devices, both proprietary and in support of customer filings
Compile materials for license renewals, updates, registrations, responsible for timely registration of the facility
Maintain regulatory files/database and chronologies in good order. Establish and maintain the system for tracking changes in documents submitted to agencies or partners
Review labeling and labels for compliance with regulatory requirements
Maintain current knowledge of Health Canada, FDA and international regulations, guidance and standards applicable to company products
Actively participate in the evaluation of regulatory compliance of document/product/ process /test methods changes.
Maintain consistent oversight of deliverables and ensures issues are escalated when needed and encourages resolution at the appropriate level. Play a key role in development and implementation of appropriate systems, processes and standards.
Manage pharmacovigilance activities for the organization.
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.
Education and Experience
University Degree in life sciences or a health care related discipline plus 3 to 5 years of relevant work experience with Regulatory Affairs in the pharmaceutical industry.
Strong working knowledge of current regulatory guidelines for FDA and / Health Canada
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 is required. Similar experience with Health Canada is an asset
Proficient with computers. Working knowledge of MS Word, MS Excel and PowerPoint, Adobe Acrobat and Document Management Systems
Knowledge of the use of eCTD Software for preparing and filing submissions is an asset
Excellent interpersonal, written, and verbal communication skills
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.