Located in Barrie, Ontario, MediPharm Labs offers a professional and collaborative workplace culture in a leading-edge facility built to international pharma standards. Our company is a recognized leader in the Cannabis industry, having won numerous cannabis and entrepreneurial awards. Our growing team of scientists, technicians, engineers and business professionals delivers quality and innovation through research, discipline, and forward thinking.Summary:The Senior Manager, Regulatory Affairs will be responsible for the management and development of the Regulatory Affairs Team, to implement and maintain the regulatory program and to obtain necessary approvals to increase and maintain MediPharm Labs products portfolio. The Senior Manager, Regulatory Affairs is also responsible for ensuring compliance with Health Canada, FDA, TGA and other global regulations. Responsibilities:Manage and execute the development of regulatory strategy to obtain timely approvals with favourable indicationsEnsure compliance with applicable rules and regulations, across the organizationDevelop and nurture effective relationships with domestic and global regulatory bodiesAnalyze and develop regulatory pathways and timelines, working with internal and external stakeholdersManage core regulatory processes including claims review, label development and literature reviewExecute optimal submission process and ensure continuous improvementMaintain regulatory records, including submissions and correspondence with domestic and global regulatory bodiesMaintain internal regulatory documents and product registration filesParticipate in key cross-functional activities, including strategy development, product lifecycle management and marketing reviewDesign and implement processes for gathering regulatory intelligence and raise awareness within the organization of current trends in regulatory development and enforcementPrepare, review and submit retail product calls for various provinces/territories upon product call request - forecast product sales to various retail channels and communicate with production team regarding orders, shipment and ETA datesSupport internal regulatory compliance by working with interdepartmental teams to establish and/or improve processes by reviewing and/or providing input regarding existing Standard Operating Procedures (SOPs), controlled forms and policiesReview and approve regulatory filings for monthly inventory reports to Health Canada, Statistics Canada and the CRAWork closely with both internal stakeholders (Marketing/Supply Chain/Quality) and external stakeholders to identify and resolve discrepancies and/or issuesParticipate in cross-functional teams and advise personnel of relevant information and communications regarding regulatory filings and licensingLead, coach and support the Regulatory Affairs team, providing feedback and instigating learning opportunitiesDefine regulatory strategies and align resources to perform regulatory affairs core tasks in a timely manner without business disruptionIdentify opportunities, anticipate risks and enable effective contingency plans when required to meet the targets and find accelerated opportunitiesContinuously monitor competitive landscape and provides valuable regulatory insight for business plans accordingly to remain industry leadersContinuously monitor competitive landscape and provides valuable regulatory insight for business plans accordingly to remain industry leadersBuild personal credibility and strong working relationships, capable to engage and lead a high performance multi-functional teamManage budget and resourcesKey Measurements of Success:Successful regulatory submission and follow upServe as subject matter expert with respect to emerging global regulatory trends, new policies and changes potentially impacting the businessEffective leadership of the regulatory teamSkills and Qualifications:Familiar with cannabis regulations for Canada; domestic and global markets preferredFamiliarity with key stages of pharmaceutical product development, manufacturing, process validation, analytical operations, compliance and documentationSolid experience in regulatory operations, including formatting, publishing, assembling and submitting (both electronic and paper submission) and records managementStrong combination of strategic thinking and tactical day-to-day problem-solving; ability to act decisively and skilled in cross-functional communicationExcellent written and verbal communication, negotiation/persuasion, presentation and interpersonal skillsAbility to provide top-quality, proactive, accurate, timely and effective support in a fast-paced environment; ability to work individually and collaboratively with a variety of individualsStrong leaderships skills, ability to coach, mentor and lead teamStrong analytical, project planning, risk identification and problem-solving skillsDetailed orientedB.Sc. in Science -preferred. SC.  (Ph.D. an asset)RAC certification an asset5+ years’ regulatory affairs experience in the pharmaceutical industry; global experience/exposure preferredMediPharm Labs is committed to providing accommodation for applicants with disabilities in its recruitment processes. If you require accommodation at any time during the recruitment process, please contact 705-719-7425 ext. 223                                                                                                                                       

Senior Manager, Regulatory Affairs

Located in Barrie, Ontario, MediPharm Labs offers a professional and collaborative workplace culture in a leading-edge facility built to international pharma standards. Our company is a recognized leader in the Cannabis industry, having won numerous cannabis and entrepreneurial awards. Our growing team of scientists, technicians, engineers and business professionals delivers quality and innovation through research, discipline, and forward thinking.

Summary:

The Senior Manager, Regulatory Affairs will be responsible for the management and development of the Regulatory Affairs Team, to implement and maintain the regulatory program and to obtain necessary approvals to increase and maintain MediPharm Labs products portfolio. The Senior Manager, Regulatory Affairs is also responsible for ensuring compliance with Health Canada, FDA, TGA and other global regulations.

 Responsibilities:

  • Manage and execute the development of regulatory strategy to obtain timely approvals with favourable indications
  • Ensure compliance with applicable rules and regulations, across the organization
  • Develop and nurture effective relationships with domestic and global regulatory bodies
  • Analyze and develop regulatory pathways and timelines, working with internal and external stakeholders
  • Manage core regulatory processes including claims review, label development and literature review
  • Execute optimal submission process and ensure continuous improvement
  • Maintain regulatory records, including submissions and correspondence with domestic and global regulatory bodies
  • Maintain internal regulatory documents and product registration files
  • Participate in key cross-functional activities, including strategy development, product lifecycle management and marketing review
  • Design and implement processes for gathering regulatory intelligence and raise awareness within the organization of current trends in regulatory development and enforcement
  • Prepare, review and submit retail product calls for various provinces/territories upon product call request - forecast product sales to various retail channels and communicate with production team regarding orders, shipment and ETA dates
  • Support internal regulatory compliance by working with interdepartmental teams to establish and/or improve processes by reviewing and/or providing input regarding existing Standard Operating Procedures (SOPs), controlled forms and policies
  • Review and approve regulatory filings for monthly inventory reports to Health Canada, Statistics Canada and the CRA
  • Work closely with both internal stakeholders (Marketing/Supply Chain/Quality) and external stakeholders to identify and resolve discrepancies and/or issues
  • Participate in cross-functional teams and advise personnel of relevant information and communications regarding regulatory filings and licensing
  • Lead, coach and support the Regulatory Affairs team, providing feedback and instigating learning opportunities
  • Define regulatory strategies and align resources to perform regulatory affairs core tasks in a timely manner without business disruption
  • Identify opportunities, anticipate risks and enable effective contingency plans when required to meet the targets and find accelerated opportunities
  • Continuously monitor competitive landscape and provides valuable regulatory insight for business plans accordingly to remain industry leaders
  • Continuously monitor competitive landscape and provides valuable regulatory insight for business plans accordingly to remain industry leaders
  • Build personal credibility and strong working relationships, capable to engage and lead a high performance multi-functional team
  • Manage budget and resources

Key Measurements of Success:

  • Successful regulatory submission and follow up
  • Serve as subject matter expert with respect to emerging global regulatory trends, new policies and changes potentially impacting the business
  • Effective leadership of the regulatory team

Skills and Qualifications:

  • Familiar with cannabis regulations for Canada; domestic and global markets preferred
  • Familiarity with key stages of pharmaceutical product development, manufacturing, process validation, analytical operations, compliance and documentation
  • Solid experience in regulatory operations, including formatting, publishing, assembling and submitting (both electronic and paper submission) and records management
  • Strong combination of strategic thinking and tactical day-to-day problem-solving; ability to act decisively and skilled in cross-functional communication
  • Excellent written and verbal communication, negotiation/persuasion, presentation and interpersonal skills
  • Ability to provide top-quality, proactive, accurate, timely and effective support in a fast-paced environment; ability to work individually and collaboratively with a variety of individuals
  • Strong leaderships skills, ability to coach, mentor and lead team
  • Strong analytical, project planning, risk identification and problem-solving skills
  • Detailed oriented
  • B.Sc. in Science -preferred. SC.  (Ph.D. an asset)
  • RAC certification an asset
  • 5+ years’ regulatory affairs experience in the pharmaceutical industry; global experience/exposure preferred

    MediPharm Labs is committed to providing accommodation for applicants with disabilities in its recruitment processes. If you require accommodation at any time during the recruitment process, please contact 705-719-7425 ext. 223

                                                                                                                                           

To apply online, please click on the appropriate link below.