Regulatory Affairs Specialist

  • Regulatory Affairs Specialist

    Regulatory Affairs Specialist
    Our client, a global healthcare leader dedicated to the development and commercialization of products to respond to unmet medical needs, have asked Bryan Forrest of Lock Search Group to assist them in their search for a Regulatory Affairs Specialist to join their team in Toronto, ON. This is a great opportunity to join a global multi-national company and contribute to global regulatory submissions. 

    Responsibilities: 
    • Prepare regulatory submissions (Canadian (new product + generic); FDA (505 b2); Japanese (PMDA)) in collaboration with Regulatory Affairs Manager; ensure submissions are complete, timely, and of high quality
    • Assist with assessment / interpretation of global regulatory bodies, update stakeholders and documents as appropriate
    • Liaise with regulatory personnel, internal teams, and external suppliers to effectively project manage timely regulatory submissions
    • Maintain effective relationships with regulatory stakeholders
    Qualifications: 
    • B.Sc. or higher in a relevant discipline (Life Sciences, Chemistry, Biotechnology, Pharmacology, Toxicology) with 2+ years of global regulatory submission experience (Japanese (PMDA) submission experience is required)
    • Proven knowledge and experience with regulatory mandates of pharmaceutical products throughout the regulatory lifecycle working with global regulatory agencies
    • Strong interpersonal / communication skills with an ability to prioritize and problem-solve in a fast-paced environment

    If interested, please submit your resume to Bryan Forrest at bforrest@locksearchgroup.com via the 
    “apply for job” button below. Please note that while we thank all applicants, only those seriously considered will be contacted. 

    Connect with Bryan Forrest: 
    e: bforrest@locksearchgroup.com 
    l: https://ca.linkedin.com/in/forrestbryan