Description
Description: The key activities of Scientific Affairs impact on the timing of market authorization with competitively advantageous product labelling. Scientific Affairs prepares and presents high-quality, credible scientific information for evaluation by Health Authorities and negotiates and develops strategies to achieve timely product approval. Scientific Affairs helps ensure that drug development plans will meet applicable regulatory requirements and supports business objectives for market access and reimbursement. In this role, Scientific Affairs evaluates the adequacy of scientific information to support product approval and liaises extensively with internal project teams and external experts as required.
Roles and Responsibilities:
- Performing pharmacovigilance activities including adverse drug reaction reporting, quarterly activities, annual summary report review and reconciliation, in accordance with SOPs, regulatory requirements, and Pharmacovigilance Agreements.
- Preparing reports and obtaining information related to pharmacovigilance deviations, including quarterly trending reports.
- Managing submission documents in support of regulatory files including CTD document preparation, formatting, proof reading and final submission compilation.
- Reviewing internal change controls including assessment of regulatory impact of proposed changes and coordination of approval process, as assigned.
- Managing label creation and revision in accordance with regulatory requirements.
- Monitoring and communicating internally new or revised regulations or guidance documents that may impact company business.
- Liaise with the external Regulatory, Pharmacovigilance and Manufacturing Departments of partners or service providers to ensure timely submissions, approvals, on-going regulatory compliance and up to date product knowledge.
- Write, review, edit and critically assess regulatory, technical and scientific documentation as assigned.
- Review marketing/ advertising material to maintain regulatory compliance and support corporate sales objectives as assigned.
Desired Qualifications:
- University degree in life sciences or a related discipline
- Post-graduate certificate in Regulatory Affairs preferred
- Minimum 1 year experience in regulatory affairs
- Excellent organizational skills with great attention to detail
- Strong written and verbal communication skills
- Highly proficient in Microsoft®Office programs
Flexible Language Requirement:
- French not required
Schedule:
- Monday to Friday
Education:
- Bachelor's Degree (preferred)
Work Location: Hybrid remote in Mississauga, ON