Associate Director- Regulatory Affairs- Gilead Sciences Job description The Head of Country Operations Regulatory Affairs is responsible for all aspects of Regulatory Affairs strategy and operations for Central America, Andina and the Caribbean, including developing and implementing the regulatory strategy and ensuring compliance with applicable laws, policies, and operating procedures in country. He/she is a member of the Country Operations leadership team, serving as an advisor on regulatory matters to the business franchises and to all relevant functional areas, such as Supply Chain, Quality Control, Public Health & Medical Affairs and Clinical, etc. He/she will be the primary link between Gilead and local health authorities, building and managing relationships with regulatory health authorities and providing intelligence to Country Operations. He/she also provides guidance as necessary to ensure market access for all marketed products. Scope: Provide the duties and support required of a Regulatory Affairs function on behalf of Gilead Sciences International. Work is performed under consultative direction towards corporate regulatory goals and objectives. Schedules and arranges own activities. Specific Responsibilities. Registration: Primary contact with national authorities for any regulatory issues regarding Gilead’s licences. Liaison with International Regulatory Affairs regarding the preparation of any submissions relating to Gilead’s products (including clinical trials, NCEs, variations and line extensions), both for licences held by Gilead, and those licences held by Distributor Partners. Submission and follow-up of all regulatory submissions to national authority. Liaison with Global Drug Safety & Public Health and International Regulatory Affairs regarding submission of PSURs, urgent safety restrictions and safety variations for national products. Submission and coordination of distribution of Dear Healthcare Provider Letters. Submission of Clinical Trial Authorisation applications and subsequent applications (amendments etc). Implementation and maintainance of labelling for marketed products in accordance with the local regulatory requirements and corporate policy. Submission of updated product labelling to national compendia. Obtain and maintain necessary regulatory-associated licences and obligations with national agencies in order to allow Gilead to conduct its business. Provision of accurate English translations of all agency correspondence and labelling for Gilead’s products, as necessary. External Liaison and Strategy in Assigned Territories. Establishment of good working relationships with national authorities. Establishment of good working relationships with regulatory groups of commercial partners/CROs assigned territories. Provision of strategic regulatory advice regarding national registration requirements to senior management and International Regulatory Affairs. Communication to International Regulatory Affairs and Drug Safety & Public Health of any new or changed national regulatory legislation/guidance/situation which may affect Gilead’s regulatory or pharmacovigilance strategy. Participation in agreed industry working groups. Commercial Compliance Activities Having oversight of the provision of scientific information about Gilead’s medicinal products in the territory. Establishing and maintaining in conjunction with local General Manager, Medical Affairs, Legal and Regulatory Compliance, a programme of training and auditing of the provision of medical information and adherence to legislation, codes of practice and Gilead internal guidelines concerning promotion and advertising of Gilead’s medicinal products. Ensuring in conjunction with General Manager and Medical Affairs that Sales Representatives in country (both Gilead and commercial partners) transmit any new information to Medical Affairs given to them by health care professionals about the use of Gilead’s products that would add to the body of knowledge about that product. Provision of guidance and assistance to Marketing (both Gilead and commercial partners) during preparation of promotional material. Review and approval of promotional material in accordance with the Gilead internal promotional guidelines, national legislation and Codes of Practice. Ensure provision of updated approved product labelling to relevant personnel, for all products. Regulatory Compliance: Coordination and preparation for local authority inspections. Preparation and maintenance of SOPs and associated process documentation as required of regulatory affairs, internally and externally. Act as Records Retention coordinator for the appropriate maintenance and storage of information according to agreed records retentions schedules for regulatory affairs. Quality: Review and approval of packaging materials in line with approved licences and Gilead’s internal processes. Liaison with Gilead Sciences regarding introduction of packaging for assigned territories. Liaison with Marketing regarding artwork changes. Pricing & Reimbursement: Provide regulatory guidance and input as required to support Gilead’s pricing strategy and negotiations with the authorities in order to obtain optimum pricing. Prepare or oversee preparation of required regulatory documentation to support the agreed pricing and reimbursement strategies
Posted on: Thu, 03 Jul 2014 03:01:06 +0000
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