Regulatory Affairs Associate
2 weeks ago
Under the direction of the department manager, the Regulatory Associate is responsible to carry out regulatory functions at Seaford Pharmaceuticals to ensure compliance with all regulatory requirements applicable to Seaford’s operations.
This position is responsible to participate in the preparation and filing of regulatory submissions and correspondence through all phases of development and product lifecycle to ensure successful product registrations for new products, and manage changes for marketed products. The position will also participate in activities related to obtaining and maintaining required facility licences and registrations.
The Regulatory Associate will provide oversight and guidance in matters related to Regulatory Compliance and Product Registrations to Seaford employees, contractors, and suppliers, to support the achievement of company objectives.
**Responsibilities**
Regulatory Affairs
- Assist with maintaining the Drug Establishment Licence (DEL) and Site Licence for the Seaford facility. Track dates to ensure that Renewal Applications are filed on time such that Licences remain active on a continuous basis. Participate in necessary activities to update or revise licences as required to accommodate new products and/or activities at the site.
- Participate in the determination of an appropriate regulatory filing strategy for each proposed new Drug or Natural Health Product, working in collaboration with Seaford Personnel, Consultants and Regulatory Agency contacts.
- Prepare and/or assist with and/or coordinate the preparation of Drug Submissions and Natural Health Product Applications for Seaford products.
- Coordinate communications between Seaford personnel, consultants and Regulatory Agencies as required to resolve any questions or concerns related to existing or proposed licencing or registration of Seaford facilities and/or products.
- Maintain an awareness of Regulatory requirements and changes affecting Seaford facility, products, and operations. Provide appropriate notice and direction to Seaford personnel on required actions to remain in compliance.
- Provide support to Seaford personnel in all matters related to Regulatory compliance. Promote awareness through presentations and training, and through day-to-day interactions and collaborative problem solving.
- Participate in the creation of, and revisions to Product labelling, including Inner and Outer Product Labels, Product Monographs and Package Inserts, to ensure the fulfilment of all Regulatory Requirements for format and content.
- Maintain the Seaford Pharmacovigilance Program, including the timely coordination of all required record keeping, research, consultation, notifications and follow-up.
- Review promotional material to ensure compliance with Regulatory requirements.
- Assist with Quality duties as opportunity and workload demands.
- Perform other related duties as assigned.
Skills and Qualifications
- A minimum of a BSc degree
- 1+ years of RA experience
- 1+ years of experience in Canadian drug and NHP submissions
- Thorough understanding of regulations and guidance published by Health Canada
- GMP & DEL requirements in Canada
- Excellent oral and written English communication skills
- Proficient in Microsoft Office
- Recent graduates are welcome to apply
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