عايز شغل

Apr 29th 2012, 17:38

Our client, a multinational Pharmaceutical company, is seeking to recruit a Regulatory Associate reporting to the Regulatory Country StrategistSenior Country Strategist.PURPOSE OF THE POSITIONSupport product licensesregistrations in a countryor group of countries within AFME from initial submissionapproval and throughout the product life cycleThe Regulatory Associate provides regulatory expertise that support the execution of Initial Submission and management of the new products (including product line extension and new indication registration) Support maintenance of marketed products (including product maintenance as manufacturing or labeling variations, renewals, etc.) Collaborate and establish a network with various stakeholdersKey Accountabilities1.1 Registration Planning Support CS with the regulatory strategies and plans for assigned countries, including review of existing regulatory guidelines and relevant literature. Provides inputs of anticipated market specific regulatory issues for planned submission.1.2 Dossier Submission and product Approval Work with in market regulatory leads to develop a detailed understanding of regulatory guidelines and technical requirements in assigned countries. Plan for the appropriate time lines of receiving and dispatching all requested documents (legalized certificated, full dossiers and samples ) to PCO s. Supporting CS in getting dossiers ready as per the planned time lines. Ensure submitted product documents will fully meet the local regulatory requirements Co-ordinate with Country Strategist the receipt, distribution and response to regulatory queries from target countries. Prepare quality dossiers and manage dispatch to PCOs within planned timelines. May support customizations and dispatch dossiers to PCOs. Coordinate and follow up with PCOs during the course of product review till approvals of all ongoing projects is obtained.1.3 Regulatory Compliance Ensures all dossiers prepared are in line with local requirements Ensure local labels created for projects within area of their responsibility, meet local and corporate criteria by providing the necessary inputs. Coordinate with GCMC in strategic planning of post approval projects across the region. Supports CS where necessary in updating systems such as RRDB and Folio planning1.4 Stakeholder management Partners with relevant functional teams, including GCMC, regional Commercial teams, PCO, Labelling team, PS and CS for projects needs and requirements.

Job Details

Preferred Candidate

Apply Now - Jobs in UAE - Jobs in Abu Dhabi, United Arab Emirates - Jobs in Dubai, United Arab Emirates - Search All Jobs