Regulatory Affairs Associate

Support of activities performed by RA team related to the products marketed by Kenvue, including medicinal products, medical devices, cosmetics.

Main Duties & Responsibilities

Maintain and update regulatory records, databases, and tracking systems to ensure data accuracy and completeness.

Support the preparation, compilation, and review of documentation for submission to regulatory authorities.

Assist in the development, review, and approval of packaging materials and artwork in compliance with regulatory requirements.

Monitor and maintain Regulatory Affairs project trackers, ensuring deadlines and key milestones are accurately recorded and communicated.

Provide administrative support to the Regulatory Affairs department, including coordinating with cross-functional teams, scheduling meetings, and preparing documentation.

Organize, maintain, and archive regulatory documentation in accordance with internal procedures and applicable regulations.

Conduct searches and retrieve information from regulatory files, databases, and archives as required.

Support ongoing departmental initiatives and contribute to the continuous improvement of Regulatory Affairs processes.

Key Skills & Competencies

Results-oriented with a strong sense of urgency and accountability.

Excellent organizational and time-management skills.

Strong ability to prioritize tasks and manage multiple deadlines effectively.

Confident in collaborating and communicating with a wide range of internal and external stakeholders.

Strong verbal and written communication skills.

Exceptional attention to detail and commitment to accuracy.

Ability to work independently as well as collaboratively within a team environment.

Sound judgment and confidence in decision-making.

Strong analytical and problem-solving abilities.

Proactive, adaptable, and highly motivated approach to work.

Qualifications

Bachelor's degree or equivalent qualification required.

Previous professional experience is not essential; however, experience in a regulated environment would be an advantage.

Academic background in Pharmaceutical Sciences, Chemistry, Biotechnology, Life Sciences, or a related discipline is preferred.

Language Requirements

Fluent Polish and English, both written and spoken.