Global Regulatory Affairs Submission Specialist (NGS Unit) – M/K

Pracodawca:

Manpower

Opis stanowiska:

Along with ManpowerGroup Solutions, we are seeking a candidate for the position of Regulatory Affairs Data Entry/ Data Integrity Specialist located in Poland to support the global processes of our client. We are offering cooperation with one of the biggest pharmaceuticals concerns in Poland. This role will work in EMEA structrue, in an international team. Seize this opportunity to become a vital part of a forward-thinking healthcare organization Apply now to contribute to impactful projects and enjoy comprehensive benefits designed to enhance your professional and personal well-being. Join the team of our client and elevate your career in regulatory affairs today!

Zadania:

• Coordinate and manage global regulatory submissions in compliance with local and international regulations
• Prepare and review regulatory documentation for product registration and renewal processes
• Ensure timely submission of dossiers to regulatory authorities and maintain ongoing communication
• Collaborate with cross-functional teams including R&D, quality assurance, and manufacturing to gather necessary data
• Monitor regulatory changes and update internal procedures accordingly
• Maintain accurate records of submission activities and regulatory correspondence
• Support audit and inspection activities related to regulatory affairs

Wymagania:

• Bachelor27s or Master7;s degree in Pharmacy, Life Sciences, or related field
• Proven experience in regulatory affairs, specifically in global submissions within the healthcare industry
• Strong understanding of international regulatory requirements and submission procedures
• Excellent organizational and project management skills with attention to detail
• Effective communication skills in English, both written and verbal
• Ability to work independently and collaboratively within a multidisciplinary team
• Proficiency in regulatory software and document management systems
• Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) is advantageous

Oferujemy:

• Competitive salary package aligned with industry standards
• Manpower Premium employment benefits including healthcare coverage
• Additional perks such as a Sport Card to support a healthy lifestyle
• Opportunities for professional development and career growth within a global organization
• Supportive and inclusive work environment in Warsaw, Poland

O pracodawcy:

Manpower (Agencja zatrudnienia nr 412) to globalna firma o ponad 70-letnim doświadczeniu, działająca w 82 krajach. Na polskim rynku funkcjonuje od 2001 roku i obecnie posiada niemal 35 oddziałów w całym kraju. Jej celem jest otwieranie przed kandydatami nowych możliwości oraz pomoc w znalezieniu pracy, która odpowiada ich kwalifikacjom i doświadczeniu.

Kontakt z firmą jest bezpłatny; można zyskać profesjonalne doradztwo oraz dostęp do ofert pracy dopasowanych do indywidualnych potrzeb.