Senior Regulatory Affairs Professional-Analyst (M/K)

Zakres obowiązków Participating in Working groups to ensure timely regional and local input into product objectives, to align regions with CDT/global strategy Working with the regional staff and LOCs to support regional and local activities Assisting in the preparation of meetings with Regulatory Agencies Assisting in the development of processes related to regulatory submissions Drafting and reviews document content (depending on level of regulatory knowledge/expertise Providing regulatory support throughout registration process and life-cycle management (e.g. iCTDs, ACTDs, renewal applications, Health Authority Responding site registrations and routine marketed product submissions including PSURs, RMPs) Advising team on required documents in preparation of submissions as assigned Responsibility for the critical review of submission documents to ensure compliance with regulatory requirements Wymagania Bachelor’s or Master’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 related especially to submission requirements for lifecycle submissions e.g., protocol amendments, post-approval variations, annual reports, PSURs, DSURs, RMPs, renewal applications Excellent organizational and project management skills with attention to detail Awareness of competitive landscape, e.g., views of HA, regulatory precedence, labeling differences and product related issues 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 Employment via ManpowerGroup Solutions based on an employment contract for 12 months Flexible work arrangement: remote (outside Warsaw) or hybrid (Warsaw-based) ManpowerGroup 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