Senior Associate, Regulatory Affairs

Job Description

Job Purpose:

Reporting to Head of Regulatory Affairs, Canada. As a senior associate in Regulatory Affairs, you will lead 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, with the support of the Senior Manager, 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

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Education

• BA/BS/University degree required; Life/Health Sciences preferred.
• Completion of a Regulatory Affairs Certification Program highly preferred

Experience, including # of years

• Minimum 2 years pharmaceutical/biotechnology industry experience with technical management experience. 
• Experience in interpretation of regulations, guidelines, and policy statements.
• Some experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements.
• Versed in MS-Office, web applications, Regulatory relevant databases (e.g., intelligence tools such as Cortellis), as well as in electronic Document Management Systems and electronic review systems.

Language(s)

• Fluent in English, both verbal and written with the ability to communicate effectively cross-functionally spanning all levels of the organization, proficiency in French an asset.

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
• Ethical: upholds high standards for performance and integrity
• Ability to work across multiple digital platforms and early adoption of new systems/applications.

Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

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.