PLG Life Sciences is seeking a skilled Regulatory Affairs Specialist with extensive experience in Core Data Sheet (CCDS) and product information management, particularly within the European Union (EU) regulatory framework.

Group 10
Responsibilities

1. CCDS and Product Information Management

  • Conduct detailed gap analysis on Company Core Data Sheet (CCDS) and Core Patient Information Leaflet (PIL) to maintain compliance with evolving EU and international standards.
  • Lead the management, revision, and regulatory alignment of product information across global markets, ensuring adherence to both local and EU requirements.
  • Collaborate closely with internal teams and client experts in pharmacokinetics (PK), Chemistry, Manufacturing, and Controls (CMC), medical, and pharmacovigilance to ensure regulatory submissions are aligned and compliant.

2. Regulatory Lifecycle Maintenance

  • Prepare and submit variation and renewal packages for Regulatory Affairs Lifecycle Management (RA LCM) in Europe and internationally, ensuring accurate, timely submissions.
  • Oversee post-approval regulatory maintenance activities, including managing product variations, renewals, and information updates to meet regulatory and client standards.

3. Stakeholder and Client Relations

  • Organize and lead meetings with client experts to align on regulatory requirements, CCDS updates, and product information, facilitating clear and actionable communication.
  • Act as a primary regulatory contact for clients, managing relationships and responding to inquiries with timely, precise regulatory guidance.

Group 12
Experience

  • Education: Bachelor’s degree in a relevant life sciences field (Master’s degree preferred).
  • Experience: Minimum of 6 years in Regulatory Affairs, specializing in CCDS and product information management within the EU market.
  • Product Information Proficiency: Extensive knowledge of product information management, with practical experience in Module 1 writing for variation applications.
  • Regulatory Knowledge: Strong familiarity with EU and international regulatory frameworks and guidelines.
  • Project Management: Proven ability to manage both simple and complex projects, with exceptional organizational and prioritization skills.
  • Languages: Fluency in French and English, with excellent written and verbal communication skills.
  • Client Relations: Skilled in managing client relationships and collaborating effectively with internal and external experts.

Regulatory Affairs Specialist - 361

Apply