Inna praca Warszawa

Opis oferty pracy

ZAKRES OBOWIĄZKÓW:

- 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