Associate Director, Emerging Market Regulatory Liaison
WarszawaAssociate Director, Emerging Market Regulatory Liaison
Warszawa
NR REF.: 1155361
Description
Warszawa
NR REF.: 1155361
Description
- Participate in global regulatory team meetings as appropriate
- Advise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned
- Have an understanding of the regional regulatory environment, and able to develop understand competitor intelligence and therapeutic area
- Act as back-up for contact with Regulatory Agencies as needed
- Draft cover letters for Regulatory Agency communication
- Assist in the preparation of meetings with Regulatory Agencies
- Liaise with LOCs, track and respond to queries in a timely manner
- Assist in development of processes related to regulatory submissions
- Draft and review some document content (depending on level of regulatory knowledge / expertise)
- Review protocols and ensure alignment with regulatory requirements
- Advise team on required documents and submission strategies in preparation of CTAs
- Ensure CTA submission packages are complete and available according to agreed timelines
- Provide regulatory support throughout registration process and life-cycle managment
- Advise team on required documents and submission strategies in preparation of MAA as assigned (in collaboration with LOCs as appropriate)
- Assist with timely MAA availability, ensure that all document components are in place on time, identify and track critical path activities
- Knowledge of the regulatory environment, guidelines and practice of EMEA regions
- University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience
- Experience in regulatory affairs
- Teamwork experience
- Project management skills
- Oral & written communication skills
- Organization & multi-tasking skills
Prosimy o aplikowanie poprzez przycisk znajdujący się po prawej stronie ogłoszenia.
