CMC Regulatory Project Manager
CMC Regulatory Project Manager
Location: Poland (remote or hybrid from Warsaw)Type of contract: B2B
Project length: 12 months with possibility of extension
Employer: ManpowerGroup Solutions Sp. z o.o.
About the Client
We are recruiting for our international client – a global healthcare company specializing in the development and production of over-the-counter (OTC) medicines and consumer health products. The organization is known for its strong scientific foundation, high-quality standards, and continuous commitment to improving patient and consumer well-being. With manufacturing and R&D sites across Europe, this company offers a stimulating and collaborative work environment where innovation, integrity, and regulatory excellence drive success.
Scope of the Role
As a CMC Regulatory Project Manager, you will lead and coordinate regulatory activities related to product lifecycle management, site transfers, and technical changes. You will act as a key liaison between Regulatory Affairs, Quality, and Technical teams to ensure compliance, efficiency, and timely delivery of CMC submissions in accordance with international regulatory standards.
Key Responsibilities:
- Lead CMC regulatory projects, including site transfer registrations, and report progress to business stakeholders
- Develop regulatory strategies for CMC aspects of site transfers, new marketing authorization applications (MAAs), and product development initiatives
- Conduct due diligence and compliance gap assessments, identifying regulatory risks and opportunities for assigned product dossiers
- Review and evaluate technical documentation, including process validation, analytical methods, specifications, and stability data
- Provide regulatory input and support for Change Controls, defining CMC strategies and actions
- Prepare, coordinate, and maintain Module 3 documentation and other CMC-related submissions (variations, reformulations, post-approval changes)
- Ensure submission timelines are met to maintain continuity of product supply and market compliance
- Collaborate with internal teams and health authorities to resolve CMC-related queries and regulatory issues
- Support MDR-related changes, product quality reviews, and other lifecycle management activities
- Monitor and interpret changes in global and regional regulatory requirements, proactively managing their impact
- Contribute to internal process improvement, development of best practices, and regulatory data integrity
Experience and Qualifications:
- University degree in Pharmacy, Chemistry, or Life Sciences (or equivalent scientific background)
- 5+ years of experience in CMC Regulatory Affairs or R&D within the pharmaceutical or healthcare industry
- Strong technical background with deep understanding of ICH Q guidelines and global quality/regulatory standards
- Proven experience with OTC medicines and various dosage forms (semi-solids, tablets, effervescent tablets, nasal preparations)
- Expertise in technical product transfers and analytical method transfers
- Demonstrated experience authoring Module 3 and managing post-approval variations
- Solid understanding of regulatory strategy and cross-functional project management
- Excellent analytical, organizational, and communication skills
- Fluent English (spoken and written); knowledge of French is an asset
- Self-motivated and adaptable to changing priorities
- Strong attention to detail and ability to handle multiple complex projects simultaneously
- Effective team player with excellent collaboration skills across departments and external partners
- High level of accountability and drive to meet regulatory and business objectives
- Passion for healthcare innovation and product quality
What We Offer:
- Flexible working model – remote or hybrid from Poland
- Competitive salary aligned with senior-level expertise
- Opportunity to work on diverse international regulatory projects
- Supportive and inclusive environment focused on collaboration and professional growth
Ready to Take the Lead?
Join our client’s Regulatory Affairs team and play a key role in shaping global CMC strategies, ensuring product compliance, and enabling access to safe, high-quality healthcare solutions worldwide.
Please submit your CV in English.