Mikołaj Grudnik

• Coordination/verification of regulatory activities performed by supervised team members
• Registration of medicinal products and submitting of post-authorisation variations ac-cording to a registration schedule. Correction of regulatory activities performed by supervised team members
• Cooperation with cooperating departments including marketing, logistics, CRO and HQ –appropriate documents or explanations obtained on time, optimised launch of new products, implementation of variations
• Timely or accelerated approval of post-authorization variations, particularly changes affecting company’s business performance
• Submission of renewals of products according to a schedule, ensuring payments for licenses granted for indefinite time are made
• Updating SPC, PIL and labelling according to the guidelines, preparation high quality translations for CP, MRP/DCP or nationally registered products
• Supervising processes delegated to less experienced team members

• Preparation of documentation and coordination of regulatory activities concerning initial registration applications, variations and renewals for human medicinal products in EU and national procedures
• Preparation of documentation and coordination of regulatory activities for medical devices
• Preparation of submission documentation in electronic format
• Managing product information texts on national level (arranging translations, verification of translated texts)
• Preparation and update of SPP’s in line with the initial registration and post-approval applications
• Keeping all the databases updated in accordance to global company’s SOPs
• Verification and approval of packaging materials (artworks) – keeping them in accordance with the approved product information / MA details
• Cross-department cooperation (especially with Marketing, Logistic and Launch Dept.) as for a proper and timely launches as well as implementation of variations
• Keeping abreast of international legislation and guidelines
• Supporting other members of the company based on workload, expertise, deadlines and importance to the commercial activities of the company
• Establish and maintain effective communication and working relationship with national Health Authorities
• Acting as local Documentum Compliance Manager coordinator
• Granted 90 MAs, 40 MAH transfers, 30 Renewals

• Preparation of documentation and coordination of regulatory activities concerning initial registration applications, variations and renewals for human medicinal products in EU and national procedures;
• Preparation of documentation and coordination of regulatory activities for medical devices;
• Preparation of submission documentation in electronic format;
• Managing product information texts on national level (arranging translations, verification of translated texts).
• Preparation and update of SPP’s in line with the initial registration and post-approval applications;
• Keeping all the databases updated in accordance to global company’s SOPs;
• Verification and approval of packaging materials (artworks) – keeping them in accordance with the approved product information / MA details;
• Cross-department cooperation (especially with Marketing, Logistic and Launch Dept.) as for a proper and timely launches as well as implementation of variations;
• Keeping abreast of international legislation and guidelines;
• Supporting other members of the company based on workload, expertise, deadlines and importance to the commercial activities of the company.
• Establish and maintain effective communication and working relationship with national Health Authorities.

• Coordination and evaluation of registration process of medicinal products in Poland
• Liasing with European Health Authorities
• Working with documentation in eCTD/Nees
• Participation in the evaluation of product information texts
• Advising on specific requirements and providing information about ongoing procedures for applicants
• Keeping abreast of national legislation and guidelines
• Preparing of specific national documents for the President of the Office for Registration, liasing with internal and external experts
• Training new employees in the registration guidelines field and IT systems