Project management of regulatory maintenance through management of global submissions (PSUR, PBRER, License renewals and annual reports).
Participate in the submissions planning process and communicating with the spoc and marketing company for smooth execution of project.
Provide technical inputs to ARAMs relating to product and strategic questions.
Providing operational management inputs and guidance to cross functional teams.
Ensuring accuracy and completeness of all regulatory activities.
THE SUCCESSFUL CANDIDATE:
A post graduate or a life sciences degree in pharmacy with 6+ years experience in regulatory domain.
Experience in EU/US/ JAPAN/ RoW Markets.
Experience in regulatory project management such annual reports, license renewal, labelling updates.
Significant knowledge of legislation and regulatory requirements across the globe.