Regulatory Affairs Manager

Location: Canada

Scope

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%)

Primary Duties: 

  • 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%)

Primary Duties:

  • 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%)

Primary Duties: 

  • 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.

Industry Experience

  • 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.

Special Skills

  • 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.

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