Regulatory Affairs Pharmacist Manager at QuintilesIMS

Key Tasks:

• Responsibility for the management of product registration activities, in accordance with corporate policies and strategic direction of Global Regulatory Affairs and according to the particularities and legislation required by country.
• Responsible for maintaining and updating the global RA databases (e.g. WPPS, CPD3, BIRDS, TAPAs)
• Manage the activities of Regulatory Affairs in order to obtain and maintain licenses, renewal and changes in product registrations; action plan with the business areas and Global RA, monitor the implementation of this plan;
• Responsibility for the management of LCM activities in compliance with the existing legislation and policies, representing the regulatory needs and priorities of local business and cooperating with SBU and Global RA/R&D teams;
• To answer the demands of regulatory authorities, as well processes and activities of the department in accordance with current policies and legislation;
• Management of information and regulatory dossiers in order to ensure confidentiality, information protection and agility to provide information.
• To identify and to anticipate developments and changes in the regulatory affairs policies or in agencies organization (Regulatory Intelligence);
• Organize and update status for the registration process;
• Develop and maintain proactive relations with the authorities responsible for regulatory affairs in the country as well as stakeholders and influencers;
• Represent BI in local industry groups
• Prepare, manage and report in RA budget in the country
• DVM or life science degree
• Regulatory Affairs in the pharmaceutical industry (human or animal)
• Multinational environment
• Relationship with regulatory and political authorities
• Leadership skills, experience in management of processes and people
• Experience working in culturally diverse teams
• Planning skills; detail orientation
• Business acumen and project management skills
• Strong accountability and results oriented