Regulatory Affairs Associate sr level

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Job Title: Regulatory Affairs Associate sr level

Description

Regulatory Affairs Associate Location: Mississauga Industry: Pharmaceutical Job Summary: Responsible for compilation and submission of dossiers for registration of products. Responsible for providing support and regulatory guidance to a team of RA Associates in the completion of projects supporting regulatory submissions. Description: • Responsible for the preparation, peer review, maintenance and timely completion of regulatory documents to support submissions to various markets • Prepare and peer review labelling, product monographs and marketing materials • Act as designate for Project Leader. Assist in review of change control documents. • Assist in product launch activities as required • Prepare, Interpret and ensure compliance with SOPs, RA policies and procedures and regulatory guidelines • Perform additional duties as assigned by RA Project Leader • Interact with other applicable departments within the company to discuss and provide solutions to regulatory issues and/or problems • Communicate with external sources (agents and suppliers) to request and/or provide data relevant to submissions • Seeks guidance from Project Leader and Manager • Assist in training of more junior staff and creates a teamwork environment Requirements: • BSc degree or equivalent in Chemistry, Pharmacy or Life Sciences • Diploma from a RA program would be an asset • Minimum 3-5 years pharmaceutical experience in an RA role • Good oral / written communication, organizational and interpersonal skills • Attention to detail • Demonstrates leadership and interpersonal skills • Computer literate; Proficiency with MS Office

Details

Job Ref:	Regulatory Affairs Associate sr level
Hours:	Full Time
Location:	Mississauga, Ontario, Canada
Working Term:	Permanent
Salary:

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