Regulatory Senior Specialist

POSITION DESCRIPTION

Reporting to the Regulatory Affairs CMC Director, the Regulatory Senior Specialist will prepare regulatory submissions for complex injectable generic drug products and biosimilars; and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements. The Regulatory Senior Specialist will provide sound regulatory input during product development.

KEY RESPONSIBILITIES

• Conducts due diligence reviews of regulatory dossiers for new business opportunities and performs gap analysis of the dossier.
• Provides cross-functional review and strategy from a regulatory, scientific and technical viewpoint.
• Coordinates the assembly, including requesting and/or generating, of documents to support submissions including complex generics and biosimilars (NDS, ANDS, SNDS, SANDS, DINA, etc.) per established business processes and systems
• Builds and maintains a healthy working relationship with business partners. Liaises with partners to collect documents and information for submission preparation or in response to technical queries/deficiency letters.
• Evaluates and ensures that submissions are accurate and meet format and content requirements as per Health Canada regulations
• Communicates effectively with internal departments (Quality, Supply Chain, Marketing, etc.) to assist in the continuation of product supply
• Contributes to an efficient and effective regulatory affairs team and uses knowledge and expertise towards a culture of continuous improvement
• Maintains current awareness of Health Canada regulatory guidelines and shares knowledge with the department

TECHNICAL SKILLS:

• Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data
• Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner
• Knowledge of GMP requirements and QA/QC procedures
• Strong understanding of Health Canada and ICH regulatory guidance documents and policies
• Proficient computer skills, including MS Office applications and Adobe Acrobat; Experience with eCTD publishing tools is an asset
• Demonstrated understanding of sterile product manufacturing is preferred

QUALIFICATIONS

• University Degree in Science or Life Sciences. Post-graduate certification in Regulatory Affairs program preferred.
• Must have a minimum of 8 to 10 years of experience with drug submissions for Health Canada, preferably with complex parenteral dosage forms and biosimilars.
• Ability to work with changing priorities that involve multiple and concurrent projects.
• Excellent oral and written communication skills.
• Strong understanding of Canadian regulatory guidance documents and policies, as well as ICH and international guidelines.