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| » Job Details | Go Back |
| Job Title: Project Leader, Regulatory Affairs |
| Description |
| Project Leader, Regulatory Affairs
Location: Mississauga
Industry: Pharmaceutical
Job Summary:
Responsible for leading a team of Regulatory Affairs Associates in the compilation and submission of dossiers for registration of products in identified markets.
Plays a key role in providing technical and scientific support to; Quality, Research and Development, as well as Sales and Marketing functions in the development of effective regulatory strategies
Description:
• Oversee compilation and review documentation by team members for submission to regulatory authorities
• Participate in product launch strategy meetings and manage the regulatory product life cycle as applicable
• Review and approve labelling, product monographs and marketing materials
• Review Change Control Documents
• Maintains and further develops an in-depth understanding of all pertinent SOPs, plus GXPs, GLP, GCP, GMP, GDPs and Safe Work Practices pertaining to regulatory affairs
• Provide leadership and training to team members to ensure the balanced growth of individuals and the development of the team as a whole
• Act as PLCM lead for the RA team as applicable. Coordinate PLCM tasks with managers and other Project Leaders
• Provide timely and appropriate reports to Manager, Regulatory Affairs as required, and act as a specialized resource to the Manager
• Relationship with Internal/External Customers & Stakeholders
• Contribute to the creation and promotion of an environment of teamwork and empowerment
• Able to represent the department at internal and external meetings
• Recommends and implement amendments to department/division policies, procedures and standards
• Creates a professional and positive team environment built on mutual trust and respect
Requirements
• Minimum BSc degree or equivalent in Chemistry, Pharmacy or Life Sciences
• Minimum 5 - 7 years experience in the pharmaceutical industry
• Minimum 3 years experience in Regulatory Affairs
• Familiarity with regulatory requirements for applicable countries e.g., TPD, EU, TGA, etc. with demonstrated ability to provide strategic regulatory opinion to management
• Good oral/written communication, organizational, leadership and interpersonal skills
• Time Management, Approachability and Team work
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| Details |
| Job Ref: |
Project Leader, Regulatory Affairs |
| Hours: |
Full Time |
| Location: |
Canada |
| Working Term: |
Permanent |
| Salary: |
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