Role:Senior Regulatory Affairs Manager - Emerging Markets
Location:Remote, UK
Company:Global Pharmaceutical
We are currently looking for a Snr Regulatory Affairs Manager with experience in Emerging Markets including Middle East Africa (MEA), Turkey, CIS & Russia (TCR) and Central Eastern European Markets (CEE). This role will be an initial 12-month contract working fulltime.
Responsibilities:
- Manages the communication, development and implementation of NDA and major line extension strategy assigned product(s) in Middle East Africa (MEA), Turkey, CIS & Russia (TCR) and Central Eastern European Markets (CEE). Working closely with global, regional and in-country regulatory teams.
- Responsible for development and delivery of regulatory strategy for assigned product(s) in Middle East Africa (MEA), Turkey, CIS & Russia (TCR) and Central Eastern European Markets (CEE). Working closely with partner and affiliate counterparts, supply chain, PV, commercial and medical colleagues where required to determine optimal NDA filing and launch strategy. Ensuring delivery of strategy to the timelines agreed working in partnership with CRO.
- Member of RPT as Regional Strategy lead for assigned product(s) providing regional insights. Attend and contribute to other various cross-functional forums, including launch meetings.
About Planet Pharma:
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
