Manager, Regulatory Affairs

3 weeks ago

Toronto, Canada Biogen Full time

Job Purpose:
Reporting to Head, Regulatory Affairs, Canada. Contribute to the development and implementation of Canadian regional preclinical, clinical and CMC regulatory strategy for products in development and/or post NDS approval, in alignment with the Canadian business strategy.

**Responsibilities**:

- Leading the planning, coordination and preparation of regulatory submissions and label development for products in development and/or post MAA approval.
- Identify and assess regulatory risks associated with assigned projects.
- Provide input on project teams and sub-committees and represent regulatory on project teams for assigned projects.
- Participate in the preparation for regulatory agency meetings and can be the contact with the authorities on specific projects.
- Review published and promotional / advertising material to support compliance with regulatory requirements.
- Perform company business in compliance with relevant regulations, company policies and procedures.
- All other duties required.

**Qualifications**
Education
- BA/BS/University degree required; Life/Health Sciences preferred.

Experience
- Minimum 5 years pharmaceutical/biotechnology industry experience with technical management experience.
- Experience in interpretation of regulations, guidelines, and policy statements.
- Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements.
- Direct experience in interfacing with relevant regulatory authorities.

Language(s)
- Fluency in English, proficiency in French is desired.

**Skills**:

- Agility: Ability to adapt to change and make timely decisions to enable agile execution
- Accountable: Comfortable working independently, a self-starter
- Customer Focused: Commitment to a customer-first culture and motivation to solving problems.
- Inclusive: High emotional intelligence in participating in / leading teams to success
- Pioneering: Innovative and willing to take risks

**Additional Information**

**Why Biogen?**

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts

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