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.
As the Regulatory Affairs Project Manager, you will be responsible for the planning, submission and management of regulatory activities for both new and marketed products. This involves the development and implementation of regulatory strategies and the management of all regulatory submissions to lead to products with the earliest approvals and optimal labeling. The successful candidate will have opportunity to manage projects across all phases of development and to cover all scientific areas of regulatory review (CMC, pre-clinical, and clinical).
You will liaise with Health Canada to support product registration process and ensure regulatory compliance. You will Interact with various global functions; in particular, Global Regulatory Affairs and Global Packaging Artwork Development. You will also partner with Quality Operations, Drug Safety, Medical Affairs and Supply Chain, and liaise with the Marketing function within the respective Canadian Therapeutic Area Business Units.
Who You Are:
- Bachelor’s degree in Life Science or relevant scientific discipline.
- You have a minimum 5 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industry.
- Demonstrated knowledge of the Canadian Food and Drugs Act and Regulations and relevant Health Canada policies and guidance documents.
- Solid understanding of product development, including pharmacology, toxicology, pharmacokinetics and clinical studies.
- Experience in the Oncology Therapeutic Area is considered an asset.
- Specific experience with Biological (BGTD) 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.