Regulatory Affairs Manager
4 days ago
SteriMax is the largest privately-owned injectable company in Canada. Our foundation rests upon the principles of providing high quality products, maintaining a reliable product supply, and supporting the needs of Canadian patients. For more details, please visit our website Responsibilities
· Manages and provides leadership to an efficient and effective regulatory affairs team. Assists in the career growth of Associates and Senior Associates.· Plans and manages regulatory submissions and activities for products throughout the life-cycle of a product in compliance with Health Canada regulatory requirements and ICH guidelines. Reviews submissions, including deficiency letters, to ensure timeliness, accuracy, consistency, completeness, and compliance with regulatory standards.· Ensures that technical data and regulatory summaries are presented clearly and succinctly to optimize the regulatory authority review and approval process.· Provides support to junior staff in the creation of submission documents and coach as necessary to ensure continuing development of regulatory skills.· Ensures regulatory maintenance of approved drug products.· Helps regulatory staff overcome difficulties in the completion of projects by diplomatically managing relationships with business partners, regulatory agencies and internal staff. Provides strategic guidance and advice.· Contributes to the creation of submission strategies throughout the product life cycle.· Shows good judgment to determine when to escalate problems to the Director of Regulatory Affairs.· Tracks critical attributes of projects to ensure accountability and efficiency.· Creates or supports the generation of reports as required.· Supports the Director in developing and implementing departmental goals to coincide with corporate goals.· Contributes to the creation and implementation of standards and best practices within the department to improve efficiency and quality of processes.· Reviews internal documentation (labeling, master batch records, specifications) and external documentation (clinical reports) for adherence to regulatory guidelines.· 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.· Builds and maintains a good working relationship with regulatory agencies. Uses the relationship to understand expectations beyond that which is presented in guidelines and policy statements. Maintains current awareness of regulatory guidelines (Health Canada, ICH, FDA, etc.).· Provides sound regulatory input and support to product development and technical transfer projects.· Represent Regulatory Affairs on interdepartmental teams for projects with Operations, Development, QA, Marketing, and other functions as required. Provides cross-functional review/input from a regulatory, scientific and technical viewpoint. Maintains and applies knowledge of product data, marketing objectives, and quality procedures.· May perform other regulatory affairs functions and activities as required to achieve departmental or operational priorities and prioritizes other responsibilities to meet additional work requirements.
Skills/Competencies Required
Ability to provide leadership and guidance to subordinates.Ability to foster and maintain a collaborative, team-based environment.Ability to influence others in a positive and effective manner.Highly organized, independent, and self-motivated with ability to multi-task.Ability to work under pressure with changing priorities that involve multiple and concurrent projects.Demonstrated ability to work within a cross-functional team.Strong analytical skills with the ability to assess scientific data.Excellent oral and written communication skills.Proficient computer skills, including relevant MS Office applications, Adobe Acrobat and eCTD submission softwareKnowledge of GMP requirements and QA/QC procedures.Understanding of all the stages of new product development (pre-market) and product life cycle management (post-market).Knowledge and understanding of the Canadian
Food and Drugs Act
and Canadian regulatory guidance documents and policies.Knowledge and understanding of ICH guidelines.
Education/Experience
University degree in Science, Pharmacy, Life Sciences with post-graduate certification in Regulatory Affairs program.No less than 8 years of relevant industry experienceNo less than 3 years of relevant Health Canada and sterile injectable experienceProven team and project management skills; Lean Six Sigma designation would be an assetStrong interpersonal and communication skills (oral & written); multi-lingual an assetPrior experience in managing teams is an asset.
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