Director, Regulatory Services
Job Description
Description
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Headquartered in Mississauga, Ontario, Q&C Services is Canada’s largest independent full-service consulting and importation firm specializing in Health Canada, US FDA, and globally regulated drugs, APIs, natural health products, and medical devices. With over 25 years of industry leadership, Q&C Services delivers expert regulatory and compliance consulting, helping clients navigate inspections, audits, and drug importation with confidence.
Backed by a team of 40+ consultants, Q&C combines deep regulatory expertise with innovative problem-solving to protect patient safety and ensure seamless client experiences. Their tailored services—ranging from Health Canada remediation and data integrity to license submissions and interim quality support—are designed for efficiency and cost-effectiveness, earning a 70% repeat business rate.
THE OPPORTUNITY
Reporting to the VP, Quality Services, the Director of Regulatory Services is responsible for planning and executing the strategic plan regarding Q&C’s regulatory services operations. Leading a team of six, they will support assorted services according to applicable regulations, working alongside the regulatory product license, facility license and pharmacovigilance teams, as well as maintaining their own client workload. The regulatory team collaborates proactively with marketing, project management, global divisions, and legal teams to ensure timely drug development, submission filings, ongoing product compliance, and effective support of pharmacovigilance activities.
DUTIES AND RESPONSIBILITIES
Network and Relationship Building
- Maintains a positive, professional, and creditable reputation both internally and externally.
- Utilizes networks, working relationships to ID strategic opportunities and potential partnerships.
- Evaluates networks to uncover opportunities for expansion, supporting the company in meeting strategic objectives and goals.
Business Planning
- Assists in creating and communicating Q&C business plans (e.g., annual business plan, team meetings, “other” updates) for the various regulatory services; and
- Develops business planning and internal ISO system management activities.
Regulatory
- Responsible for regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory submissions.
- Establishes regulatory project plans to capture all aspects of the scope of work.
- Provides expertise, guidance on regulatory applications from Drug, NHP and Medical Devices.
- Prepares and submits major applications to Health Canada, including NDS, SNDS, ANDS, DMFs, and others.
- Provides eCTD publishing for major submissions to Health Canada, including NDS, SNDS, ANDS, DMFs, and others.
- Possesses working knowledge of Structured Product Labelling (SPL).
- Supports Health Canada and client GMP audits.
Pharmacovigilance Services
- Supports periodic pharmacovigilance reports (PSURs, ADRs, sADRs, MRPs) as required.
- Conducts Patient Support Program, infusion clinics and Good Clinical Practice site audits.
- Possesses working knowledge of Pharma Promotional Review and PAAB guidelines.
- Participates in clinical/non-clinical study review and authoring summaries support.
- Supports Health Canada and client GMP audits.
Facility License Services
- Supports team managing Drug Establishment License, Medical Device Establishment License and Site License.
Service Delivery
- Approves project plans and changes, coordinating resources to ensure full-service delivery.
- Assists with project kick off, closeout, and post-mortems.
- Ensures projects remain on time and on budget.
- Moves forward on corrective actions and continuous improvement actions.
- Troubleshoots client-related problems and areas of concern for consultants, if applicable.
- Meets efficiency and consultant optimization targets.
- Recommends and implements improvements to the delivery service model.
- Approves project plans and changes, coordinating resources to ensure full-service delivery.
- Assisting with project kick off, closeout, and post-mortems.
- Ensuring projects stay on time and on budget.
- Move forward on corrective actions and continuous improvement actions.
- Establishing and implementing new metrics to measure service levels and quality.
- Providing operating oversight of consultant activity including production scheduling, work-in-hand management, and service quality.
- Develops Q&C processes/systems for scalability; and Maximize use of available tools.
Human Resources
- Develops the Q&C Regulatory team.
- Manages Q&C team schedules and workloads.
- Manages employee time off scheduling and approvals.
- Works closely with Human Resources to attract and retain exceptional talent; assist in hiring.
- Overseeing HR activities related to Management of Q&C teams (e.g., employee hiring, terminations)
- Inspires, motivates, and advises the internal team to meet agreed-upon goals (systematic team feedback, rewards, and recognition).
- Coaching, mentoring, and developing regulatory teams.
- Identifies and help develop SMEs.
- Supports the professional development of consultants.
- Manages the team to ensure compliance with Q&C standards and practices.
- Manages direct reports and project teams; and
- Performs annual performance review sessions with direct reports.
Business Development
- Participates in and supports business development initiatives.
- Builds solid relationships with stakeholders to meet commitments, solve challenges, manage expectations, and expand the opportunities and revenue within client.
- Supports sales teams such as product, facility license, and pharmacovigilance Subject Matter Expert (SME); and
- Determines whether Q&C can meet client needs, support Development meetings, proposal development and approve proposals.
EXPERIENCE, EDUCATION and TRAINING
- 10+ years managerial experience in a pharmaceutical environment with exposure or experience with consulting organizational structures would be an asset.
- 7+ years’ experience in drug, natural health products, and medical device regulatory application work.
- High agility, flexibility, and on-going learning & upskilling.
- Demonstrated excellence in building high performing teams.
- Technical writing experience.
- Advanced MS Office skills (Word, Excel, PowerPoint, Visio, Access, Outlook). Regulatory Focused Knowledge:
- General knowledge of drug development.
- Proven expertise in the regulations governing drugs, natural health products (NHPs), and medical devices is regarded as an advantage.
- Strong knowledge of current Canadian regulations both GMP and GVP.
- Experience in interpreting regulations, guidelines, and policy statements, including:
- Food & Drug Act and regulations (F&DA)
- Good Clinical and Manufacturing practice (GCP/GMP)
- PAAB Code of Advertising Acceptance
- Health Canada policies, guidelines, and forms; ICH guidelines
- Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
- Strong experience with CTD format, including preparation of Module 1 documents.
CONTACT INFORMATION
About LHH Knightsbridge –
Seniority level
-
Seniority level
Director
Employment type
-
Employment type
Full-time
Job function
-
Job function
Quality Assurance, Product Management, and Management
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Industries
Business Consulting and Services and Pharmaceutical Manufacturing
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Company
Q&C Services
Location
Mississauga
Country
Canada
Salary
100.000
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