Regulatory Affairs Associate

Posted 15 Oct 2019

Mississauga, Ontario - Canada

Req Id 198853

Details

A career with EMD Serono is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.


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.


What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com


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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