Regulatory Compliance Specialist
hace 6 días
Regulatory Affairs Officer - 082
In alignment with ongoing initiatives for one of our key clients, we are seeking a Regulatory Affairs Officer to oversee post-marketing authorization activities (Life Cycle Management) specifically for the Canadian market.
Key Responsibilities:
- Oversee post-approval processes (Life Cycle Management) for the Canadian market.
- Initiate change control processes, including regulatory evaluations of modifications in accordance with Health Canada guidelines.
- Coordinate and execute the necessary regulatory steps until the completion of the change control.
- Prepare regulatory submissions in compliance with national standards.
- Document and monitor regulatory submissions and approvals from regulatory authorities.
- Review packaging materials for compliance.
- Conduct format reviews of Summary of Product Characteristics, Patient Information Leaflets, and labeling (e.g., QRD compliance checks).
- Assist in data entry within PLG tools to facilitate the measurement of KPIs and metrics for regulatory services.
Education & Experience:
- A Bachelor's degree or higher in a Life Sciences discipline. A Pharmacy degree is advantageous.
- A minimum of 2 years of experience in Regulatory Affairs within the Pharmaceutical sector or through a Service Provider.
Required Skills:
Hard/Technical Skills:
- Proven experience in regulatory lifecycle management activities for pharmaceutical products (Renewals, Change Controls, PI updates, technical variations) in Canada (to Health Canada).
- Familiarity with Canadian regulations governing pharmaceuticals (NCE, Biologicals, and Biotech), Medical Devices, and Combination products.
- Understanding of CMC documentation (Module 3) relevant to the Canadian market.
- Experience managing change controls within the Canadian regulatory framework.
Soft Skills:
- Proficiency in English is essential; French language skills are a significant advantage.
- Strong organizational and interpersonal abilities.
- Excellent communication skills.
- Capability to work effectively both independently and as part of a team.
- Ability to manage multiple tasks and prioritize workloads efficiently.
- Competence in meeting tight deadlines.
- Detail-oriented with a process-driven mindset.
- Solution-oriented approach to challenges.
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