Regulatory Affairs Specialist

Regulatory Affairs Mississauga, Canada Canada Field Based


Description


The Regulatory Affairs Specialist will report to the Regulatory Affairs Director and support senior regulatory professionals by executing against the Canadian regulatory plans and actively participating in the management of submissions under regulatory review at Health Canada.  The successful candidate will develop an understanding of regulatory guidance and precedent in the oncology setting. Under general supervision, the Regulatory Affairs Specialist will provide sound regulatory input and advice across projects as applicable.

Principal Responsibilities:

  • Prepare routine regulatory submissions for investigational and marketed products (e.g., Clinical Trial Applications, New Drug Submissions, Supplemental NDS, post-Notice of Compliance changes) in line with Canadian and ICH requirements and scientific and company policies and procedures
  • Assist in preparing responses to Health Canada requests for general information
  • Assist with preparations for Health Canada interactions
  • Review individual submission components, administrative and technical, for quality and completeness
  • Interface with Regulatory Operations to define and track submission content
  • Act as the key local person responsible for document management system (ie) VEEVA RIM with responsibilities and administrative duties as applicable
  • Contribute to building and implementing local process and planning improvements in the regulatory department
  • Monitor the regulatory environment in Canada and help identify changes in regulatory legislation and competitor information for assigned product(s) or projects
  • Maintain up to date understanding of regulatory guidelines (Health Canada, ICH, FDA, etc.) and sharing this knowledge with the department
  • Participate in other projects and duties as directed by senior RA personnel

Qualifications: 

  • Bachelor’s degree in a life sciences discipline
  • Post-graduate certification in regulatory affairs is considered an asset
  • Minimum of 2+ years of relevant regulatory experience in commercial pharma/biotech industry is required 
  • Experience with preparation and compilation of CTAs, NDSs, SNDSs, and NCs for Health Canada is preferred
  • General knowledge of the fundamentals of Canadian regulatory legislation and guidance documents. Global knowledge of drug development process is an asset
  • Experience in Regulatory CMC is an asset
  • Fluent in English (written and spoken); French is an asset
  • Strong written and verbal communication skills and interpersonal skills
  • Strong organizational skills to manage conflicting priorities and adhere to tight timelines
  • Proficient computer application skills including Microsoft Office (Outlook, Excel, Word, Access)
  • High attention to detail with accuracy and quality
  • Strong information seeking skills and ability to work under moderate supervision

As the leading employer in our industry Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. To learn more about Seagen please visit www.seagen.com.

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, provincial, or local law.

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