Pharmaceutical Senior Manager Regulatory Affairs
2 weeks ago
Our client is a dynamic, growing company and are looking for a motivated professional in Regulatory Affairs to support their growth. The Regulatory Affairs (RA) Manager will provide regulatory expertise and support for the approval and maintenance activities that should meet the Federal regulatory requirements for Canada and the United States of the company’s Products.
This role is a full-time permanent position, and it is based out of Oakville.
KEY RESPONSIBILITIES:
- Supports the submission process for new drug submissions, supplements, amendments, and updates in support of business objectives.
- Oversees and coordinates Third-Party support to ensure pre-defined deliverables are achieved.
- Preparation of required Regulatory documents/dossiers such as regulatory submissions, Annual Drug Notification forms for Canada and for the US market.
- Manages regulatory/pharmacovigilance SOPs and ensure all functional operations are in accordance with Federal regulations.
- Develops draft responses to Health Canada, and/or review responses and documents intended for submission to Health Canada to ensure compliance with regulatory standards.
- Serve as a focal point with Health Canada and develop effective working relationship with Health Canada
- Plan and conduct Health Canada meetings.
- Provides support for Market Access drug listings.
- Provides support for drug product Import/Export Licenses for manufacturing sites.
- Oversees FDA submissions including product-specific import/export licenses as applicable.
- Ensures global pharmacovigilance activities are compliant with all applicable regulations.
- Coordinates audit preparation and regulatory Pharmacovigilance inspections and audit responses.
- Maintain awareness of the Canadian regulatory environment and assess impact of pertinent changes that may affect the organization.
EXPERIENCE REQUIRED:
• BSc/MS in Pharmaceutical Sciences, Pharmacy, Chemistry, or Related Fields.
- +15 years of Regulatory experience in New Drug development and registration including a minimum of 10 years of Regulatory Affairs or pharmacovigilance experience.
- Exposure and/or experience with US drug files is an asset but not a requirement.
- Extensive experience with Post Approval of Product Changes.
- Experienced in filing Patent Form IVs.
- Experienced in or have managed PV data collection, and preparation of report summaries for submission to Health Canada/FDA.
- Experience with a PV audit.
KNOWLEDGE & SKILLS REQUIREMENTS:
- Knowledge of Canadian regulations (Food and Drugs Act and Regulations), Good Manufacturing Practices, Drug Establishment Licensing
- Regulatory Affairs Certification (RAC) is a plus.
- Excellent interpersonal written and oral communication skills
- Proficient in Microsoft Office including advanced skills in Excel.
- Ability to coordinate, contribute to and work within a cross-functional team.
- Ability to assess the regulatory impact of changes via the change control process.
- Experience with global pharmacovigilance systems is an asset.
- Overall knowledge of pharmaceutical development, manufacturing and packaging, registration, and market access approval processes.
- Sound problem-solving and negotiation skills.
- Ability to liaise with Health Canada
- Able to interpret and assess impact of new regulatory requirements.
- Strong interpersonal, analytical and organization skills
- Strong organizational, problem solving and analytical skills.
- Strong written and oral communication skills
- Strong attention to detail
- Ability to handle multiple projects and priorities, while meeting project deadlines
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