Regulatory Affairs Manager, Biosimilars Canada
3 weeks ago
About This Role
The Biosimilar Regulatory Manager Canada, will be responsible for development and implementation of Canadian regional regulatory strategies for Biosimilar product development for assigned assets in CA, in alignment with the global business strategy. Responsible for contributing to the strategy and regulatory planning in Canada in collaboration with the global team, and their execution, ensuring the requirements of Heath Canada are accounted for. Responsible for regulatory documents, submissions, and compliance issues. Represent the company with regulatory authorities for RA and PV. Management and oversight of outsourcing and vendors for in-country RA execution where needed. Contribute to Biosimilar regulatory policy in Canada, coordinating and providing input from BBU in partnership with internal policy teams.
What You’ll Do
Responsible for managing the co-ordination and execution of all aspects of regulatory submissions relevant to assigned projects or programs in Canada, including but not limited to licence applications, licence maintenance, aRMM management, labelling and artwork management, and promotional & non-promotional reviews.
Provide for providing regulatory input on project teams and subcommittees for regulatory processes and product development. Providing input to local and global teams and building cross-functional relationships.
Participate in the preparation for regulatory agency meetings and be the RA contact with the Canadian authorities on designated projects. Build and maintain relationships Canadian regulatory bodies, contractors and corporate partners in line with company position. Prepare and deliver effective presentations for internal and external audience.
Oversight and management of external vendor(s). Co-ordination of in-country RA activities. Provide guidance and recommendations to team members to ensure compliance with local regulations, processes, and requirements
Identify and assess regulatory risks associated with product development and lifecycle management on assigned products. Contribute to risk mitigation strategies.
Responsible person and agency contact for In-country Regulatory and Pharmacovigilance on assigned biosimilar products, partnering with global RA & PV functions to address agency requirements
Monitor and inform of in-country regulatory requirements, policy initiatives, reference product and competitor intelligence. Contribute to assessment of potential impact and development of action plans/ company positions as needed.
Perform company business in compliance with relevant regulations, company policies and procedures.
All other duties required.
Who You Are
A regulatory professional with experience of regulatory procedures and requirements in Canada. Ready to grow their experience further and build their area of responsibility. Enjoys working both independently and in collaboration with global and cross functional teams.
Why Biogen?
Biogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients. As a company, Biogen recognizes that cutting-edge science and medicines can change the course of devastating diseases. Biogen’s development of advanced biologic biosimilars will bring medicine to those who need them most.
Qualifications
Required Skills
BSc degree in pharmacy, chemistry, biology, pharmacology or related life sciences subject At least 4-years’ experience in regulatory affairs in the pharmaceutical/biotechnology industry Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements Good knowledge of applicable regulations, regulatory guidelines and submission requirements and ability to interpret regulations and guidelines. Direct experience in interfacing with relevant regulatory authorities. Experience in interpretation of regulations, guidelines, and policy statements.Preferred Skills
Ability to foster effective, positive relationships with key stakeholders, including global teams, cross functional teams, regulatory agencies, corporate partners, and vendors. Ability to represent the department in project teams, committees, and external meetings to attain group goals. Ability to work independently with minimal supervision. Demonstrate excellent communication skills: detail oriented, effective written and oral communication skills. Demonstrate strong organizational skills, including the ability to prioritize personal workload and to manage a large volume of complex tasks. Ability to oversee and mentor other team members/ vendors
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. to learn more about our DE&I efforts.
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