Regulatory Affairs Manager (ASEAN) – Pharma/Clinical
Line manager: Associate Director / Director, Global Regulatory Development
Basic Purpose and Objective:
To provide regulatory advice on strategy and manage projects in the provision of regulatory affairs services and liaise with internal and external clients in the provision and marketing of these services for those countries of responsibility.
Supervisory responsibilities: May be required to supervise other regulatory affairs individuals depending on business need.
Duties and Responsibilities (according to relevant guidelines, laws and SOPs)
1. Provide project specific regulatory services and co-ordination of projects
2. Review and assist in preparing regulatory submissions
3. Build and maintain local, central and external relationships in order to influence the regulatory environment
4. Effective interaction with authorities to support local/central functions and assigned activities
5. Effective communication/reporting on assigned activities
6. Provide input to regulatory strategy and product development advice to Global Regulatory Affairs Development
7. Contribute to development & implementation of Global/APAC Regulatory function/plans
8. Maintain knowledge of, understand and ensure compliance with PPD SOPs, Client SOPs/directives, and current regulatory guidelines regarding clinical trials, regulatory documents and other regulatory submissions
9. Provide regulatory advice and training for regulatory affairs in the company
10. Manage other local regulatory affairs individuals, as necessary
11. Assist in local business development and pricing of projects for Regulatory Affairs in the company
In addition,
• Provide a regulatory intelligence service to the organization with respect to ASEAN regulatory and associated requirements
• Lead and train a small group of regulatory professionals and/or regulatory consultants as required depending on business need
• Assist in budgeting as necessary
• Other duties as required
Qualifications: Degree in Pharmacy, Medicines or Life Sciences preferred, a higher qualification in a relevant subject and/or post-graduate course in Regulatory Affairs would be an advantage
Skills and knowledge: Broad regulatory affairs experience
Extensive knowledge of ASEAN regulatory applications and procedures, especially those related to clinical trials. Knowledge and experience of regulatory application and procedures in Taiwan and/or India will be a distinct advantage.
Proven success in agency influencing and negotiation
Good knowledge of ICH/Global/Asia Pacific Regulatory Procedures/Guidelines
Good knowledge of global / regional / national country requirements / Regulatory Affairs Procedures for Clinical Trial Authorization and Marketing Authorizations
Good interpersonal skills are essential
Proven ability to work effectively in a team
Must be able to work on own initiative
Good organizational and planning skills
Able to plan their work at least several months ahead
Able to manage and plan projects and other people
Familiar with computers and their applications
Good English essential, any other ASEAN languages would be an advantage
Mental skills required in areas of reading and interpretation of data, numeracy, language, analytical, investigative, verbal and written communication, customer contact, attention to detail, multiple project tasking
Physical skills required include good general health to carry out the high volume of workload and client interaction under pressure
Experience:
Suitable level of experience within a broad range of Regulatory Affairs projects, a good knowledge of global / regional Regulatory Affairs for clinical trials and marketing authorization procedures. ASEAN Regulatory Affairs experience essential. Previous managerial or supervisory skills would also be an advantage.
Interested and qualified candidates can send their resumes directly to woeiwoei.goh@ppdi.com
