Regulatory Affairs / Life Cycle Manager (with Arabic) - Remotely Work
Miejsce pracy: WarszawaManpower (Agencja zatrudnienia nr 412) to globalna firma o ponad 70-letnim doświadczeniu, działająca w 82 krajach. Na polskim rynku jesteśmy od 2001 roku i obecnie posiadamy prawie 35 oddziałów w całym kraju. Naszym celem jest otwieranie przed kandydatami nowych możliwości, pomoc w znalezieniu pracy odpowiadającej ich kwalifikacjom i doświadczeniu. Skontaktuj się z nami - to nic nie kosztuje, możesz za to zyskać profesjonalne doradztwo i wymarzoną pracę!
RESPONSIBILITIES:
- Line management and coaching of assigned Life Cycle Managers (LCMrs) from a specific region or cluster, including performance review, goal setting/ assessment, people development and absence planning (coordinate/ oversee absences and back-up planning for own region/ cluster).
- Act as a primary contact between the LCM Lead and the assigned LCMrs.
- Advise ERMC LCMrs on LCM processes, tools/systems and communications to ERMC colleagues, LOC(s), TA(s), CMC-RA and other stakeholders.
- Act as ERMC LCM for assigned cluster(s) (for further details on the principle responsibilities for Life Cycle Managers, please read the role profile ‘EMEA RMC Life Cycle Manager’).
- Ensure proper onboarding, mentoring and training of all Life Cycle Managementteam members in your region, in close cooperation with ERMC LCM Lead.
- Proactively follow-upwith LCM activities for your region, on an ongoing basis, to monitor submissions and follow-up on planned/pending submissions.
- Stimulate and arrange sharing of knowledge and learnings to bring team to a higher level.
- Proactively define and analyse gaps in processes and other region-specific needs for the assigned region or cluster(s) to help improve the submission- and other ERMC-processes.
- Leading region-specific projects for Lifecycle Management or other projects as assigned by LCM Lead and participates in other tasks as assigned by ERMC Head.
- Ensure regulatory compliance of the Lifecycle Management team activities.
- Participate in audit-readiness activities.
- 1 to 3 years of relevant experience in management of RA variations for CMC and labeling -> preference with experience in Middle East:
- (GCC (Bahrain ,Kingdom of Saudi Arabia (KSA), Kuwait, Oman, Qatar, United Arab Emirates (UAE), Yemen)
- JENA (Egypt, Ethiopia, Sudan, Jordan, Libya)
- NE (Lebanon, Iran , Iraq and Syria)
- Fluent in English and Arabic (additional French language skills would be a preference)
- Good communication skills, including in working remotely
- Experience with e-CTD
- Experience in a multinational company is a bonus
- Work Remotely From Home
- Full-time employment
- One-year global project opportunities involving international collaboration and knowledge sharing
- An interesting and challenging job in an international company
- Great atmosphere and chance to work with inspiring people from all around the world
Prosimy o aplikowanie poprzez przycisk znajdujący się po prawej stronie ogłoszenia.
