AGM/DGM/GM - Regulatory Affairs & Liasioning - Emerging Market - Pharma

We come up with the excellent opening for the position of AGM / DGM / GM Regulatory Affairs and Liasioning Emerging Market with Top Pharma at Pune

Job Title : Regulatory Affairs and Liasioning - Emerging Market

Location : Pune

Job Description :

Specific regions : GCC / Middle East / North Africa / French West Africa / East Africa and South Africa / APAC

Requirements :

01. Candidate should have thorough exposure on GCC and Saudi Arabian dossier filing requirements.

02. Hands on exposure on GCC eCTD compilation and submissions would be preferred.

03. Knowledge / exposure of GCC/ SFDA site inspection would be essential

04. He/ she should be able to communicate / coordinate with South Africa and other African country heads / Business teams for Regulatory affairs and Technical aspects.

05. Coordinate and communicate with internal stakeholders / service providers and provide necessary clarity on regulatory filings and requirements in specific country / territory.

06. Knowledge of MCC ZA CTD dossier compilations / understanding of strategies to file the US or EU dossiers.

07. Valid passport availability.

08. Need to travel to the countries and meet the MOH along with country managers, as and when and if required-

09. Arrange the Telecons/ Videocons with territory / country heads and update them with Regulatory status, discuss the registration issues and conclude them amicably.

10. Should have knowledge and understanding for ACTD compilations and filings in APAC countries

11. Knowledge of Russia / CIS, Latin American filings would be useful.