CMC Regulatory Project Manager



Manpower (Agencja zatrudnienia nr 412) to globalna firma o ponad 70-letnim doświadczeniu, działająca w 82 krajach. Na polskim rynku jesteśmy od 2001 roku i obecnie posiadamy prawie 35 oddziałów w całym kraju. Naszym celem jest otwieranie przed kandydatami nowych możliwości, pomoc w znalezieniu pracy odpowiadającej ich kwalifikacjom i doświadczeniu. Skontaktuj się z nami - to nic nie kosztuje, możesz za to zyskać profesjonalne doradztwo i wymarzoną pracę!

CMC Regulatory Project Manager
Miejsce pracy: Warszawa
Nr Ref.: 23026

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
Personal Profile:
  • 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.

Prosimy o załączenie do aplikacji następującej klauzuli: "Niniejszym wyrażam dobrowolnie zgodę na przetwarzanie danych osobowych zawartych w moim CV przez ManpowerGroup Sp. z o.o. z siedzibą w Warszawie przy ul. Nowogrodzkiej 68, do celów związanych z procesem rekrutacji zgodnie z Ustawą z dnia 29 sierpnia 1997 r. o ochronie danych osobowych (tekst jednolity: Dz. U. 2014 r. poz. 1182). Wyrażam także zgodę na udostępnianie moich danych osobowych innym podmiotom z grupy Manpower oraz potencjalnym pracodawcom do celów związanych z procesem rekrutacji. Przysługuje mi prawo dostępu do moich danych i ich poprawiania."

Agencja zatrudnienia – nr certyfikatu 412.
APLIKUJ TERAZ