Job Description
Summarized Purpose:
Serves as the lead over several countries/projects in providing innovative solutions including regulatory expertise and client interface to provide strategic regulatory intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. Acts as liaison with internal and external clients in the provision and marketing of these services.
Essential Functions:
¡¤ Provides senior review of regulatory documents and submissions created within or outside of the company in order to ensure high quality standards that meet or exceed client expectations, local and regional requirements.
¡¤ Acts as subject matter expert in providing regulatory strategy advice to internal and external clients on projects of moderate complexity. Provides internal clients with up-to-date legislation and guidance as it becomes available.
¡¤ Participates in project management activities to support the provision of regulatory services, and acts as liaison with internal and external clients in the provision of marketing these services.
¡¤ Provides matrix/project leadership, training and guidance to junior team members to support understanding of regulations, impact on study, assessment of risk, etc., and to achieve a specific goal and/or project deliverables.
¡¤ May provide input on performance reviews to management.
¡¤ Ensures adherence to project budgets, time schedules, and scope of work.
¡¤ Ensures compliance with relevant organizational and regulatory SOPs and WPDs
¡¤ Can manage and support local regulatory projects and related activities as a country regulatory lead, and also perform a regulatory affairs lead role in global clinical trial and regulatory standalone projects such as RA consulting and NDA/BLA.
¡¤ Can lead local/regional/global regulatory discussions with internal team and clients with excellent communication and interpersonal skills; must have fluent verbal and written English skills
¡¤ Have good project management skills (including budget management). Line management experience will be a plus.
¡¤ Has experience in performing local regulatory submissions for clinical trials and marketing authorization for drugs in Korea, and managing (or being involved in) global CTA/IND projects; global experience is a plus, but must have excellent knowledge in the ICH guidelines and key local/regional regulatory requirements & processes in drug development and be able to expand to the global role after joining PPD.
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
Excellent English language (written and oral) communication skills as well as local language where applicable
Great attention to detail and quality as well as excellent editorial/proofreading skills
Strong interpersonal skills to work effectively in a team environment and act as a liaison with other departments
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