The Senior Regulatory Affairs (RA) Associate, PLCM will be responsible for the execution of regulatory activities to support currently-marketed products to ensure post-approval regulatory compliance. This position is responsible for preparation and submission of post-approval regulatory activities (supplements, annual notifications, post-DIN changes), along with regulatory change control assessments to ensure post approval regulatory compliance of the product. In addition, the Senior RA Associate assists the Sr. Manager, RA in the training and guidance of junior staff members.
- Adheres to corporate, regulatory and individual responsibilities supporting the Company’s quality management programs, supporting policies, procedures, work instructions, and relevant software (Documentum)
- Participates actively in project team meetings and provides Canadian regulatory requirements to the respective functions within the project team in accordance to the current Health Canada and ICH requirements
- Compiles and submits regulatory dossiers in accordance to the current Health Canada guidance documents as required
- Conducts accurate regulatory assessment for post-approval changes and identifies level of filing and data requirements
- Communicates with Health Canada's directorates to facilitate approval of regulatory submissions
- Assists Senior Manager, RA in reviewing submission and change assessments prepared by junior staff
- Provides regulatory support to the Quality and Marketing departments in product prelaunch activities as required
- Supports development and implementation of departmental and cross-functional process improvement
- Bachelor of Science Degree in one of Chemistry, Microbiology, Biology, Pharmacology or other life science is required at minimum
- Minimum of four years of pharmaceutical experience in a regulatory affairs capacity
- Prior experience in the healthcare or pharmaceutical industry is preferred
- Strong technical knowledge of CMC requirements and ability to analyze scientific data are required
- Strong knowledge of Health Canada guidelines & regulations and understanding of global regulatory requirements
While all applications are appreciated, only successful applicants will be contacted.