Regulatory Affairs Manager/ Delivery Site Lead
nr ref: 298/8/2024/AK
Gdańsk (pomorskie), Poznań (wielkopolskie)
29 sierpnia 2024
W Antal zajmujemy się rekrutacją od ponad 20 lat. Dzięki działaniu w 10 wyspecjalizowanych dywizjach, świetnie orientujemy się w aktualnych trendach branżowych. Precyzyjnie określamy specyfikę stanowiska, klasyfikując kluczowe umiejętności i niezbędne kwalifikacje. Naszą misją jest nie tylko znalezienie kandydata, którego kompetencje wpisują się w wymagania danego ogłoszenia, ale przede wszystkim stanowiska, spełniającego oczekiwania kandydata. Numer rejestru agencji zatrudnienia: 496.
Regulatory Affairs Manager/ Delivery Site Lead
For the client - one of the largest pharmaceutical companies, we are looking for a Regulatory Affairs Manager to lead teams of Regulatory Specialists in Poland
Responsibilities:
- Lead the hub site to deliver timely, high-quality submissions.
- Serve as the main contact for client regional leads.
- Ensure compliance with country-specific regulatory requirements.
- Establish new processes and documentation.
- Manage team attrition, resources, and budget effectively.
- Proactively address concerns with the Engagement Manager.
- Ensure team compliance with the general training plan and mandatory courses.
- Close project audit findings within agreed timelines.
- Oversee training record compliance.
Requiremets:
- Bachelor’s or Master’s degree in life sciences or pharmacy.
- Experience in Regulatory Affairs for Pharmaceuticals, Biologics, Chemicals, or Medical Devices.
- Familiarity with regulatory publishing tools (eCTDXpress, ISI toolbox, Firstdoc, Insight publisher).
- Experience with US and EU submissions (CTD/eCTD/NeeS).
- 6-10 years in Regulatory Operations and Document Publishing.
- Knowledge of 21 CFR part 11 and Good X Practice (GxP).
- Preferred skills: experience in submission publishing and emerging markets, as well as regulatory affairs certification.
We offer:
- Extensive benefits package: Multisport Card, LuxMed medical healthcare including dental care, life insurance, cafeteria benefits,
- Open-minded and multinational environment,
- Opportunity to be part of a global organization focused on development,
- Professional development and a clear career path,
- Training & development opportunities including language courses.
