Senior Principal RA Scientist

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!

Job Tasks:

• Collaborate with global teams to develop and execute CMC regulatory strategies for pharmaceuticals, devices, and advanced therapies

• Coordinate global submission plans aligned with local regulatory requirements

• Oversee preparation and submission of regulatory dossiers to health authorities

• Lead responses to health authority inquiries and internal strategy alignment

• Manage key initiatives within CMC Regulatory Affairs and support due diligence/licensing activities

• Provide guidance to team members and promote compliance with regulatory standards

• Represent CMC Regulatory Affairs in cross-functional teams and act as a regulatory expert

• Ensure regulatory strategies align with global regulatory affairs, therapeutic areas, commercial functions, and Quality Target Product Profile (QTPP)

• Maintain communication with Therapeutic Area Regulatory Affairs to ensure strategic alignment

• Refine regulatory strategies based on new data and escalate critical issues as needed

• Develop contingency plans for risks related to registration and compliance

• Communicate effectively with health authorities and lead meetings when appropriate

• Review regulatory dossiers and assess changes in chemistry, manufacturing, and control throughout product lifecycle

Requirements:

• Degree in biological, pharmaceutical, chemical, or engineering sciences; minimum 10 years’ experience in pharmaceutical or healthcare industry

• Ability to communicate regulatory requirements clearly

• Knowledge of biology, chemistry, or engineering relevant to pharma

• Experience developing regulatory strategies and product development

• Attention to detail and strong communication skills

• Ability to work cross-functionally and present regulatory strategies

• Experience interacting with Health Authorities

• Knowledge of global regulations and industry competitors

Offer:

• Opportunity to work for a global Big Pharma company

• Stable job environment

• Join an international, dynamic team and contribute to innovative projects in global markets

• Option for 100% remote work within Poland

• Work primarily in English

• Benefits package including healthcare, sports card, and insurance 

Permanent job offer.