Reporting to the General Manager, the Manager of Regulatory Affairs will be responsible for all aspects of Regulatory Affairs including but not limited to the responsibilities and duties described below:
Key Responsibilities and Primary Duties
Key Responsibility: Regulatory Affairs (80%)
- Provide guidance on regulatory requirements for pharmaceuticals products within North America, with main focus on Canada.
- Respond to regulatory authority deficiency letters in a timely manner.
- Lead project team members to define submission strategies and to coordinate submission priorities
- Allocate appropriate Regulatory Affairs (RA) resources as per changing priorities/timelines in order to maintain a high-performance work environment
- Compile and submit regulatory submissions mainly for Canada.
- Design systems to manage activities for paper-based and electronic submissions.
- Maintain product licenses, including quarterly and annual reports.
- Assess and when required, submit annuals and supplements to existing product approvals.
- Review and when required, submit updated product labelling.
- Review and when required, submit marketing material to regulatory authorities.
- Prepare and track formulary submissions and listings as required.
- Liaise with Quality, Manufacturers and Product Development as required for preparation and maintenance of product approvals.
- Conduct due diligence activities.
- Develop and train staff to ensure the successful fulfillment of their duties and professional growth.
Key Responsibility: Quality Assurance Support (10%)
- Support efficient and timely release of products to the marketplace, establish and maintain quality standards and related policies for all finished products.
- Participate in regulatory inspections and follow-up on corrective actions and commitments made as a result of internal/external audits.
- Support to establish and enforce GMPs and Quality Control Procedures.
- Liaise with internal and external partners to ensure compliance with product approvals, regulatory requirements, and GMPs.
- Assists in the development and implementation of Quality Assurance programs and projects including the management of SOPs, change controls, document management, investigations, and annual product reviews.
Key Responsibility: Business Development (10%)
- Liaise with internal and external partners to support product launch.
- Provide regulatory strategies and input for new development / pipeline projects
- Other related activities.
Qualifications & Skills
Education Requirements: B.Sc. in chemistry, pharmacy or another life science.
- Minimum 5 years experience as a Regulatory Affairs Professional. Experience with parenteral products preferred.
- Thorough and demonstrated knowledge of TPD, FDA and ICH guidelines, GMPs, regulations and other relevant policies.
- Strong communication skills (written and verbal).
- Ability to multi-task, remain flexible, manage priorities, and adhere to deadlines.
- Demonstrated ability to remain calm under pressure.
- Proficiency in MS Word, Excel, Access, Sharepoint, Outlook, eCTD software and Internet.
This description outlines the principal functions of the job identified and should not be considered a detailed description of all requirements that may be inherent in the job.