Description
SUMMARY:To apply an extensive knowledge and interpretation of regulatory affairs and products to the drug development process, including promulgation of health authority marketing authorization dossiers to enable efficient and effective registration of medicinal products consistent with the supported regions commercial objectives. Ensure that regulatory documentation meet relevant regulatory requirements.
REGULATORY:
Provide strategic input into the regulatory aspects for planning &execution of global clinical trials programme; Provides country/regional support to the Clinical trials Regulatory Unit (CTRU) in the development of clinical trial applications for the target countries or products; Prepares IRD and CTD submissions for NMEs, including liaison with contributing groups and review of components; Prepares IRDs and CTDs for line extensions; Liaise with internal and external technical experts responsible for preparation of expert documentation for inclusion in IRD and CTD submissions and apply regulatory expertise to enable preparation of high quality documentation; Advise on the development of regulatory documentation that meets relevant regulatory requirements and ensure that the documentation meets relevant regulatory requirements and that compliance with departmental procedures is assured; Co-ordinate with Country Strategist the receipt, distribution and response to regulatory queries from target countries, in line with product role, consistent with departmental procedures and including liaison with RRT members to ensure that response targets are met; Contribute to the preparation of global regulatory strategies and plans for the targeted EM countries, including review of existing regulatory guidelines, competitor products and relevant literature; May lead preparation for, and attend where appropriate, meetings with regulatory authorities, including preparation of background materials, logistical organisation and assisting in preparation of meeting minutes; Develop detailed understanding of EM regulatory guidelines and technical requirements and a broad understanding of the global regulatory environment; Develop specialized areas of expertise in assigned regulatory and therapeutic areas; May undertake assigned regulatory projects, including review of guidelines and contribute to the improvement of departmental and divisional processes; Ensures business compliance and implementation of and adherence to Regulatory standards; Ensure that comprehensive records of communications and regulatory status are maintained; To regularly follow up progress on regulatory submissions; Ensure that line management are advised of progress in regulatory filings.
PROJECT MANAGEMENT:
Represents the organization at relevant project team, or interdivisional meetings, as appropriate; Leads dossier planning activities for assigned projects, including liaison with other regulatory groups to support co-ordinated global filings; May lead process and procedure improvement activities.
EDUCATION & EXPERIENCE:
Scientific Degree; Significant experience across the Drug, Discovery, Development or commercialization life cycle, or significant experience in Regulatory Affairs; Proven ability to manage complex regulatory or drug development issues; Proven ability to consistently deliver to time, cost and quality standards.
SKILLS
FDA Regulations, Project Timelines, International Regulatory/Safety Regulations and Guidelines
Synectics is an Equal Opportunity Employer.