PLG is a global service provider in Life Sciences, dedicated to supporting patient access to safe and effective healthcare solutions. We deliver worldwide consulting and outsourcing services through the entire product life cycle. Our team is diverse, entrepreneurial, and committed to continuous improvement and innovation, and now we are looking for a Legal Counsel to join our dynamic legal team
Key Responsibilities
Key Responsibilities
- Perform regulatory publishing in eCTD, NeeS, ePaper, and ACTD formats in compliance with regional requirements.
- Manage and coordinate submission activities across EU, US, Canada, Australia, GCC, ASEAN, and other markets.
- Ensure accurate and timely compilation, publishing, validation, and dispatch of regulatory submissions.
- Collaborate with cross-functional teams including Regulatory Affairs, CMC, QA, and external partners to meet submission timelines.
- Oversee project planning, status tracking, and risk mitigation to ensure successful and compliant submission delivery.
- Lead and mentor junior publishing team members and provide technical and process guidance.
- Utilize publishing tools such as eCTDManager, DocuBridge, and validate outputs using agency-compliant tools.
- Maintain documentation in eDMS systems and ensure alignment with regulatory and company standards.
- Participate in process improvement initiatives and contribute to SOP creation and updates.
- Stay updated on regional and global regulatory submission guidelines and publishing trends.
- Bachelor’s degree in any discipline (Life Sciences preferred but not mandatory).
- 6+ years of hands-on experience in eCTD publishing with demonstrated experience in global markets.
- Proven experience in project coordination and team management within a regulatory publishing environment.
- Proficient in publishing tools such as eCTDManager and Lorenz DocuBridge.
- Familiar with electronic Document Management Systems (eDMS).
- Understanding of regulatory affairs processes is a plus.
- Strong attention to detail and commitment to quality.
- Excellent organizational and multitasking skills with the ability to prioritize effectively.
- Proactive, adaptable, and capable of working in a fast-paced, deadline-driven environment.
- Strong interpersonal and communication skills to work effectively with cross-functional and global teams.