Description du poste Regulatory Affairs
- ProductLife Consulting
We offer a one-stop shop for consulting services dedicated to the life sciences
Regulatory Affairs
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Regulatory Affairs Officer - 044
004-placeholder Morocco - Remote work possible - Regulatory Affairs 003-clock Permanent contract
Regulatory Affairs Officer - 082
In the context of additional activities for one of our main clients, we are looking for a Regulatory Affairs Officer working from Mexico or Canada to manage post-MAA activities (Life Cycle Management) for the Canadian market.
Group 10 Responsibilities
Management of post approval activities (Life Cycle Management) for the
Canadian market Initiate change controls, including regulatory assessment of the change in accordance with Health Canada guidances. Coordinate and perform the subsequent regulatory steps until closure of the change control. Compile regulatory dossiers in accordance with national requirements. Document and track regulatory submissions and regulatory authority approval. Provide review of packaging texts. Provide format review of Summary of Product Characteristics, Patient Information Leaflets, and labelling (e.g., QRD compliance check). Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services
Group 11 Education & Experience
Bachelor's degree or more in a Life Sciences related field. Pharmacy degree would be a plus. At least 2 years of experience in Regulatory Affairs in the Pharmaceutical Industry or via a Service Provider
Group 13 Skills
Hard/Technical skills:
Experience in regulatory lifecycle maintenance activities for drug products (Renewals, Change Controls, PI updates, technical variations) in Canada (to Health Canada) Knowledge of the Canadian (CA) regulations for pharmaceuticals (NCE, Biologicals and Biotech), Medical Devices, Combination products Knowledge of CMC documents (Module 3) on the Canadian market Experience with change controls on the Canadian market
Soft skills:
Fluent English is mandatory, French would be a great plus Excellent organizational and interpersonal skills Excellent communication skills Ability to work well within a team and autonomously Ability to prioritize different workloads/multi-task Ability to deliver on tight timelines Process orientated with good attention to detail Solution driven
Regulatory Affairs Officer - 044
Privacy Preference Center
Manage Consent Preferences
Always Active
Détails du poste Lieu de travail Maroc Domaine de la société Cabinet d'Avocats Type de société Non spécifié Type demploi Non spécifié Salaire mensuel Non spécifié Nombre de postes à pourvoir Non spécifié