Regulatory Affairs Associate

Job description

Regulatory Affairs Associate

Your Role: As the Regulatory Affairs Associate, you will be responsible for supporting the Regulatory Affairs function to meet Company and department objectives.  You will perform Regulatory Affairs activities associated with business continuity initiatives and compliance management for all Therapeutic Areas. You will be responsible for the creation, review, approval and maintenance of product labeling.  You will plan, compile, and prepare documents for eCTD submissions to Health Canada including responses to Clarification / Information Requests.  This role will manage regulatory dossiers under Health Canada review, and maintain current authorizations and licenses through annual renewal submissions.

 

Who You Are : You have a minimum 2-4 years of experience in Canadian Regulatory Affairs in the biotechnology, pharmaceutical industry or at Health Canada.  You have a University degree in a Life Science or a relevant scientific discipline.  The successful completion of a Postgraduate Regulatory Affairs Certificate or a similar designation such as RAC (CAN) is a definite asset.

 

You have demonstrated knowledge of the Canadian Food and Drugs Act and Regulations and relevant Health Canada policies and guidance documents.  You have a solid understanding of product development, including pharmacology, toxicology, pharmacokinetics and clinical studies.  Experience with Biological (BGTD) post-approval CMC submissions is a strong asset.

Job Requisition ID: 198853

Location: Mississauga

Career Level: C - Professional (1-3 years)

Working time model: full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

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