Company Background:
Our client is a well-known MNC company in various technology and services industries.

AIM OF POSITION:

To manage the Asia Pacific National Regulatory Affairs (NRA) group. This includes responsibility for all local regulatory activities in support of the compliance, registration and promotion of GEHC products in both subsidiary and distributor markets within the region. This operational management position works closely with central RA and local and regional commercial groups. In some markets the AP NRA group is also responsible for providing local functional support to the central PV, MPS and QA groups, according to a defined schedule. A key part of this national RA role is to ensure GEHC has strong and effective relationships with local regulatory authorities..

RESPONSIBILITY: 

• To ensure regulatory compliance for MDX products in the region
• To drive that local RA activities reflect both local commercial and global business priorities. To partner with regional commercial.
• To drive the development and strengthening of MDX relationships with regulatory authorities
• To participate in strategic planning and implementation for the NRA function as part of the NRA senior management group
• To ensure consistent and quality regulatory practices and procedures across the region, which are in line with the rest of NRA.
• To manage the regulatory activities of contractors and consultants in the distributor markets
• To liaise with heads of QA, PV, MPS and central RA, and ensure that these groups receive the functional support as agreed.
• To lead and develop an effective team of internal and external regulatory professionals
• To direct activities and manage the resources required to provide regulatory input and support for assigned IT Healthcare products, in accordance with business needs. 
• To provide proactive regulatory advice and expertise to other groups
• To act as liaison with external regulatory bodies, as required, to ensure appropriate input into regulatory strategy and gain rapid approval of submissions.
• To continuously review and put strategies in place to improve existing processes and champion implementation of new initiatives
• To manage the recruitment, development and training of each member of their team.
• The incumbent will have autonomy within the defined role.  Decision making responsibility will be defined by the tasks at hand and the business implications of those decisions, including maintenance and tactical level business implications. Where decisions have strategic business implications, these will require approval and input by the National RA Head and/or Global Head of Regulatory Affairs.

QUALIFICATION/EXPERIENCE REQUIREMENT:

• At least a first degree in a scientific discipline.  An advanced degree would be desirable (e.g. MS, PhD, MD).
• Extensive experience (10-15 years) in regulatory affairs. A considerable amount of this experience (>5-7 years) should have been gained in a national regulatory management role, and include extensive experience of negotiating directly with regulatory authorities.
• Man management experience and demonstrated ability to lead and manage teams effectively.

Specific competences required (optional)

• Will be expected to work independently to manage the activities of the team and has accountability for these activities.  Able to manage, motivate, develop and recruit high quality personnel to develop and maintain a highly effective team.
• Ability to interact with an individual or team to provide timely, constructive and authoritative regulatory opinion and advice on all regulatory aspects. 
• Will proactively identify issues and problems, have the ability to identify and assess risk and the chances of regulatory success, and offer solutions and recommendations on product/project issues.  Able to make decisions under conditions of uncertainty.
• Ability to represent the regulatory position effectively in order to influence both internally within the company and externally with regulatory authorities.
• Must adapt to change, challenge the status quo and champion new activities. They will act as a catalyst for change, stimulate others to change and manage implementation effectively.
• Will demonstrate excellent communication skills, speak and write clearly and convincingly, tailoring communication methods to customer's requirements and make effective presentations.
• Will effectively manage regulatory processes to ensure competitive approvals and maintenance of products.  Will possess extensive knowledge and experience of regulatory process relevant to their activities and have a working knowledge of other global regulatory processes.  Will use judgement in operation of processes for strategic advantage.