_{29th January, 2025}

Job description: Project Leader, Product Lifecycle Management (PLCM)
Are you passionate about making a meaningful impact in the healthcare industry? Join a growing, global organization dedicated to improving the safety, affordability, and accessibility of care that medical professionals provide to their patients.
This organization is committed to fostering great leaders, building collaborative teams, and driving business success. Employees are valued as key contributors to the company's achievements, receiving the resources and opportunities to reach their potential while working with managers who prioritize professional development. Integrity, collaboration, passion, creativity, and excellence are the cornerstones of the company culture.
This is an opportunity to join a workplace where your efforts make a real difference, supported by a clear sense of purpose and shared values.
We are currently seeking a full-time Project Leader, Product Lifecycle Management (PLCM) to join our team.
Compensation and work schedule

• Salary: $95,000 - $115,000 per year.
• On-site: Monday, Tuesday, and Wednesday.
• Work from home: Thursday and Friday.

Basic function
The Project Leader, Regulatory Affairs - Product Lifecycle Management (PLCM) is a vital part of the Scientific Affairs department, reporting to the Manager/Senior Manager of Regulatory Affairs PLCM. This role focuses on managing technical and scientific regulatory activities related to the lifecycle management of approved and marketed products.
The successful candidate will serve as a key decision-maker on regulatory issues, ensuring project deadlines are met, and will also provide training and guidance to associates to maintain high submission quality standards.
Key responsibilities

• Provide strategic input and technical guidance to development teams on regulatory requirements, adhering to current Health Canada and ICH standards.
• Author and review regulatory submissions following Health Canada guidance documents.
• Interact with regulatory authorities during submission preparation and review processes to ensure timely approvals.
• Monitor and address applicable deficiency responses from regulatory authorities.
• Conduct accurate regulatory assessments for post-approval changes, identify filing requirements, and oversee regulatory actions.
• Ensure compliance with post-marketing approval requirements.
• Stay updated on regulatory guidelines (Health Canada, ICH, etc.) and promote technical expertise within the regulatory department.
• Monitor and communicate the impact of regulatory changes to internal stakeholders.
• Serve as the point of contact with Health Canada directorates.

Qualifications

• Education:
  • Bachelor of Science degree in Chemistry, Microbiology, Biology, Pharmacology, or another life science field (required).
  • Completion of a regulatory affairs college program (asset).
  • Regulatory Affairs Certification (RAC) (asset).
• Experience:
  • Minimum of five years of pharmaceutical experience in a regulatory affairs capacity.
• Skills:
  • Strong technical knowledge of CMC requirements for liquid dose and complex molecules.
  • Ability to analyze, organize, and present scientific data for submission compilation.
  • Comprehensive understanding of Health Canada regulations and global regulatory requirements.
  • Excellent written and verbal communication skills.
  • Strong attention to detail, time management, and multitasking abilities.
  • Exceptional organizational and problem-solving skills.

Accessibility commitment
This organization is dedicated to meeting the accessibility needs of individuals with disabilities, ensuring compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Accommodations are available upon request to support an accessible hiring process and workplace environment.
If you are ready to advance your career and contribute to meaningful work in the healthcare industry, we want to hear from you!
If you are ready to join the team, please connect with us:
Michelle Payne
michelle.payne@archstaffing.ca
#INDR1
 
About Arch Staffing and Consulting
Arch is a diverse and global staffing firm incorporated in 1993. Along with our other divisions, we employ over 20,000 consultants in 72 offices around the world. Arch Staffing & Consulting will be the premier global staffing resource our clients, candidates, and colleagues count on. We focus on finding our candidates their ideal job, and we help our clients find ideal candidates.
Arch provides professional and commercial services for all industries, including information technology, accounting & finance, administration, skilled trades, engineering, healthcare, and industrial.
 
Our team has more than 100 years of combined experience in the staffing industry, and a large network of proven talent. We have built a culture that attracts and retains the best talent in the industry. At Arch Staffing, placement is just the beginning of the process.
 

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