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| » Job Details | Go Back |
| Job Title: Regulatory Affairs Associate |
| Description |
| Regulatory Affairs Associate
Location: Mississauga
Industry: Pharmaceutical
Job Summary:
The Regulatory Affairs – Solid Dose (US) team is responsible for the management of regulatory activities in relation to products under development (New Product Development (NPD)) as well as those currently registered and marketed PLCM in the US.
The team plays a key role in providing technical and scientific support to; Quality, Research and Development, as well as Sales and Marketing functions in the development of effective regulatory strategies
Description:
• Responsible for the preparation and completion of regulatory submissions to various markets
• Prepare post approval supplements / annual reports to support changes and/or to manage the regulatory product life cycle as applicable
• Prepare and/or review labelling, product monographs and marketing materials
• Perform additional duties as assigned by RA project Leader
• Assist in the preparation, drafting and compliance of SOPs and regulatory guidelines
• Interact with other applicable departments within to provide solutions to regulatory issues and/or problems
• Communicate with external sources (agents and suppliers) to request and/or provide data relevant to submissions
• Makes complex interpretation and application decisions relating to regulatory guidelines and policies.
• Addresses and resolves complex regulatory activities in support of submissions
• Seeks guidance from other team members and Project Leader to enhance regulatory knowledge
Requirements:
• BSc degree or equivalent in Chemistry, Pharmacy or Life Sciences
• Diploma from RA program is an asset
• Minimum 3 years pharmaceutical experience associated with drug development and drug submissions
• Minimum 1-2 years pharmaceutical experience in an RA role
• Good oral / written communication, organizational and interpersonal skills
• Proficiency with MS Office
|
| Details |
| Job Ref: |
Regulatory Affairs Associate |
| Hours: |
Full Time |
| Location: |
Mississauga, Ontario, Canada |
| Working Term: |
Permanent |
| Salary: |
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