Regulatory Affairs Manager, Biosimilars Canada

4 weeks ago

Old Toronto, Canada Biogen, Inc. Full time
Regulatory Affairs Manager, Biosimilars Canada (15 Month Contract))
  • Full-time
  • Region: EU+/Canada

Position Job Title: Biosimilars Regulatory Affairs Manager, Canada

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.

  • 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

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.

#J-18808-Ljbffr

  • Regulatory Affairs Manager, Biosimilars Canada

    4 weeks ago

    Toronto, Canada Biogen Full time

    **Job Description** Position Job Title: Biosimilars Regulatory Affairs Manager, Canada** **Location: Hybrid - Toronto, Ontario** **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...

  • Pharmaceutical Senior Manager Regulatory Affairs

    1 week ago

    Toronto, Canada Optimum Staffing Solutions Inc. Full time

    Our client is a dynamic, growing company and are looking for a motivated professional in Regulatory Affairs to support their growth. The Regulatory Affairs (RA) Manager will provide regulatory expertise and support for the approval and maintenance activities that should meet the Federal regulatory requirements for Canada and the United States of the...

  • Pharmaceutical Senior Manager Regulatory Affairs

    1 week ago

    Toronto, Canada Optimum Staffing Solutions Inc. Full time

    Our client is a dynamic, growing company and are looking for a motivated professional in Regulatory Affairs to support their growth. The Regulatory Affairs (RA) Manager will provide regulatory expertise and support for the approval and maintenance activities that should meet the Federal regulatory requirements for Canada and the United States of the...

  • Pharmaceutical Senior Manager Regulatory Affairs

    1 week ago

    Toronto, Canada Optimum Staffing Solutions Inc. Full time

    Our client is a dynamic, growing company and are looking for a motivated professional in Regulatory Affairs to support their growth. The Regulatory Affairs (RA) Manager will provide regulatory expertise and support for the approval and maintenance activities that should meet the Federal regulatory requirements for Canada and the United States of the...

  • Manager, Regulatory Affairs

    6 days ago

    Toronto, Canada Options Consulting Solutions Full time

    MANAGER, REGULATORY AFFAIRSFULL-TIMEOTTAWA OR TORONTOAre you in expert in health products regulations and submissions?The CompanyOur client is a national trade association renowned for the fantastic everyday products they offer. They are looking for an expert in regulatory affairs with a learning mindset and determination to be a top contributor to take the...

  • Associate Director Regulatory Affairs

    1 week ago

    Toronto, Canada Pharma Partners Recruitment Ltd Full time

    Job Title: Project Leader, Regulatory Affairs A Pharmaceutical business in Toronto, Canada is looking for a Project Leader, Regulatory Affairs to join their Global team. In this role you will Responsible for the Regulatory Affairs project management of development and marketed products. Responsib

  • Associate Director Quality Assurance

    2 days ago

    Old Toronto, Canada Scientific Search Full time

    Associate Director – Quality Assurance & Regulatory Affairs Location: Toronto, OntarioSummary: Join a pivotal leadership role at a top-tier pharmaceutical company focused on pathbreaking scientific advancements. As an Associate Director of Quality Assurance & Regulatory Affairs, you will ensure compliance with Health Canada's stringent standards,...

  • Associate Director Quality Assurance

    2 days ago

    Old Toronto, Canada Scientific Search Full time

    Associate Director – Quality Assurance & Regulatory Affairs Location: Toronto, OntarioSummary: Join a pivotal leadership role at a top-tier pharmaceutical company focused on pathbreaking scientific advancements. As an Associate Director of Quality Assurance & Regulatory Affairs, you will ensure compliance with Health Canada's stringent standards,...

  • Associate Director Quality Assurance

    7 hours ago

    Old Toronto, Canada Scientific Search Full time

    Associate Director – Quality Assurance & Regulatory Affairs Location: Toronto, Ontario Summary: Join a pivotal leadership role at a top-tier pharmaceutical company focused on pathbreaking scientific advancements. As an Associate Director of Quality Assurance & Regulatory Affairs, you will ensure compliance with Health Canada's stringent standards,...

  • Associate Director Quality Assurance

    2 days ago

    Old Toronto, Canada Scientific Search Full time

    Associate Director – Quality Assurance & Regulatory Affairs Location: Toronto, OntarioSummary: Join a pivotal leadership role at a top-tier pharmaceutical company focused on pathbreaking scientific advancements. As an Associate Director of Quality Assurance & Regulatory Affairs, you will ensure compliance with Health Canada's stringent standards,...

  • Associate Director Regulatory Affairs

    2 weeks ago

    Toronto, Canada Pharma Partners Recruitment Ltd Full time

    Job Title: Project Leader, Regulatory Affairs A Pharmaceutical business in Toronto, Canada is looking for a Project Leader, Regulatory Affairs to join their Global team. In this role you will Responsible for the Regulatory Affairs project management of development and marketed products. Responsibilities: Provide regulatory strategic and operational...

  • Associate Director Regulatory Affairs

    2 weeks ago

    Toronto, Canada Pharma Partners Recruitment Ltd Full time

    Job Title: Project Leader, Regulatory Affairs A Pharmaceutical business in Toronto, Canada is looking for a Project Leader, Regulatory Affairs to join their Global team. In this role you will Responsible for the Regulatory Affairs project management of development and marketed products. Responsibilities: Provide regulatory strategic and operational...

  • Associate Director Regulatory Affairs

    2 weeks ago

    Toronto, Canada Pharma Partners Recruitment Ltd Full time

    Job Title: Project Leader, Regulatory Affairs A Pharmaceutical business in Toronto, Canada is looking for a Project Leader, Regulatory Affairs to join their Global team. In this role you will Responsible for the Regulatory Affairs project management of development and marketed products. Responsibilities: Provide regulatory strategic and operational...

  • Regulatory Affairs Specialist

    1 month ago

    Toronto, Canada LEO Pharma Full time

    Role Description Overall Objective:   Contribute to, and/or manage, the preparation and regulatory review of filings to Health Canada for both new and existing drug products. This includes the preparation of New Drug Submissions, Supplemental New Dug Submissions, Notifiable Changes, Annual Drug Notifications, and Clinical Trial...

  • Associate Director Regulatory Affairs

    2 weeks ago

    Toronto, Canada Pharma Partners Recruitment Ltd Full time

    Job Title:Project Leader, Regulatory Affairs A Pharmaceutical business in Toronto, Canada is looking for a Project Leader, Regulatory Affairs to join their Global team. In this role you will Responsible for the Regulatory Affairs project management of development and marketed products.Responsibilities:Provide regulatory strategic and operational input to...

  • Associate Director Regulatory Affairs

    2 weeks ago

    Toronto, Canada Pharma Partners Recruitment Ltd Full time

    Job Title:Project Leader, Regulatory AffairsA Pharmaceutical business in Toronto, Canada is looking for a Project Leader, Regulatory Affairs to join their Global team. In this role you will Responsible for the Regulatory Affairs project management of development and marketed products.Responsibilities:Provide regulatory strategic and operational input to...

  • Associate Director Regulatory Affairs

    2 weeks ago

    Toronto, Canada Pharma Partners Recruitment Ltd Full time

    Job Title: Project Leader, Regulatory Affairs A Pharmaceutical business in Toronto, Canada is looking for a Project Leader, Regulatory Affairs to join their Global team. In this role you will Responsible for the Regulatory Affairs project management of development and marketed products.Responsibilities:Provide regulatory strategic and operational input to...

  • Regulatory Affairs Officer.

    4 weeks ago

    Toronto, Canada PSI Full time

    Job Description Join our team of experts in regulatory and ethics submissions of clinical studies! You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career. This is a hybrid role which includes remote and in-office work.  Your role: Responsible for...

  • Associate Director Regulatory Affairs

    2 weeks ago

    Toronto, Canada Pharma Partners Recruitment Ltd Full time

    Job Title: Project Leader, Regulatory Affairs A Pharmaceutical business in Toronto, Canada is looking for a Project Leader, Regulatory Affairs to join their Global team. In this role you will Responsible for the Regulatory Affairs project management of development and marketed products. Responsibilities: Provide regulatory strategic and operational input...

  • Associate Director Regulatory Affairs

    2 weeks ago

    Toronto, Canada Pharma Partners Recruitment Ltd Full time

    Job Title: Project Leader, Regulatory Affairs A Pharmaceutical business in Toronto, Canada is looking for a Project Leader, Regulatory Affairs to join their Global team. In this role you will Responsible for the Regulatory Affairs project management of development and marketed products.Responsibilities:Provide regulatory strategic and operational input to...