Our client is a global healthcare company dedicated to providing life-saving medicines and technologies for patients worldwide. With a focus on delivering high-quality, innovative products, they specialize in critical care, nutrition, and infusion therapy. They are committed to improving patient outcomes driving their research and development efforts and ensuring that healthcare professionals have access to reliable and advanced solutions.
The Senior Manager, Regulatory Affairs PLCM and Project Management provides regulatory expertise and support for marketed products following the current regulatory requirements. The Senior Manager is responsible for leading teams to deliver project(s) across one or more business units.
The position interacts with internal and external stakeholders including quality, commercial, supply chain and Health Canada.
- Commits to being fully engaged, caring, and enthusiastic about the organization and its goals
- Fosters a work environment conducive to an engaged team; leading by example and managing by engagement principles and learnings
- Adheres to corporate, regulatory and individual responsibilities supporting the Company’s quality management programs, supporting policies, procedures, work instructions, and relevant software (Documentum).
- Adheres to the Company’s commitment and to policy on the Code of Conduct
- Adheres to organizational and individual health and safety responsibilities in the workplace
- Maintains up-to-date health and safety training
- Leads and mentors the Regulatory Affairs PLCM team in timely and accurate post-approval regulatory change assessments, ensuring compliance with Health Canada requirements and business expectations
- Prioritizes RA workload and deliverables to ensure on-target regulatory submissions to meet business needs
- Assists and supports the development of regulatory strategies and implementation plans for the preparation and submission of supplemental applications; SNDS, SANDS, post DINA
- Reviews regulatory submission materials to ensure accuracy, comprehensiveness, completion, and compliance with current regulatory standards
- Plans resource needs and works with Human Resources to recruit, interview, and select experienced and suitable candidates for the department, as needed
- Ensures team completes all required training within the Company’s Learning Management System(s) on time and in compliance with Company requirements and maintains up-to-date records
- Participates and communicates regulatory intelligence and/or strategies in cross-functional teams ensuring clear and concise understanding and interpretation
- Maintains up-to-date knowledge and expertise of Health Canada guidelines and relevant regulations; advises on implementation, delivers team training as needed
- Leads collaborative meetings or communications between Health Canada and/or internal and external organizations/colleagues to resolve issues, provide regulatory insights and technology transfer guidance as needed
- Defines Project scope of work for new projects; clearly identifying tasks and responsibilities for all project team members and establish target completion dates for key deliverables/milestones
- Interface with directors and senior management to facilitate resource allocation and prioritization to achieve project milestones on target
- Track and maintain project oversight within established project management tracking tool(s) to provide project oversight, capacity planning and dashboard updates
- Manage project and team budgets and participate in quarterly forecasting/budgeting exercises as required
- Represents the company in industry association meetings as assigned
RELATIONS WITH OTHERS
- Internally there is interaction with staff and management of all local and regional internal departments including but not limited to: Finance, Human Resources, Supply Chain Management, Customer Service, Sales, Marketing, Vigilance and Quality, as applicable
- Externally interacts with global teams, regulatory authorities and third-party manufacturers
- BSc in Chemistry, Microbiology, Biology, Pharmacology or other life science is required, MSc preferred
- 5+ years of pharmaceutical experience in regulatory affairs (at least three years in a management capacity)
- 3+ years of Project Management experience
- Thorough understanding and detailed, sound knowledge of Canadian regulatory requirements including all applicable policies and guidelines to therapeutic products is required
- Good understanding of the global regulatory requirements, mainly FDA and EMA
- Excellent leadership skills
- Excellent communication skills (written and verbal)
- Excellent customer service skills and the ability to collaborate with all levels both inside and outside the organization
- Strong computer skills in MS Office, Adobe Acrobat and SharePoint software
- Strong attention to detail with the ability to multitask and handle fluctuating workloads
- Excellent organizational and problem-solving skills
- Excellent continuous improvement skills
- Proven ability to adhere to standards and procedures and maintain confidentiality
- Ability to lead and manage a team as well as simultaneous projects
Represented by Abigail Van Riesen, PhD – Scientific Recruitment Consultant
firstname.lastname@example.org | 519.222.6474
Thank you in advance for your interest, only individuals deemed to have the skill set and experience to fit the role will be contacted.
Lock Search Group is a National Executive Recruitment firm with 11 offices in Canada and one in the United States, a staff of more than 30 Consultants and Associates, and expertise in 11 major disciplines. Our mission is to provide exceptional Recruitment and Consulting Services to clients and candidates. We apply our experience and expertise to deliver solutions with a personalized approach that focuses on client needs and candidate goals.
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