GRA Asia, Head of ASEAN+ Region

Major Responsibilities：

• Position reports directly to the Head of GRA Asia and is based in Beijing, People’s Republic of China.
• As member of the GRA Asia Management Team, actively contributes to the GRA Asia organization by representing the Region to achieve alignment of Regional business and development objectives with GRA, GRA Asia, and Global Development (GD) Asia strategies and objectives.
• Implements and chairs regional Regulatory Affairs (RA) Managers Meeting for the Region.
• Directs regional RA budget for the Region.  Contributes to the management of the regional RA budget in achieving the Regional AP Medical Affairs, Global Development and Bayer Schering Pharma-AP financial targets.
• Responsible for capacity planning, budget and resource management for the assigned region in context of overall GRA Asia organization.
• Responsible for local Personnel Portfolio, Succession Planning, and other HR activities within assigned region.
• Provides input to AP country Medical Directors & Regional Head regarding capacity, budget and resource planning for the AP Region.
• Negotiates resources with the Head of GRA Asia as well as with regional and local Business Management as needed.
• Develops and maintains motivated and competent RA staff in the region through participation in hiring, training, development and advancement.
• Contributes to  local RA Personnel development, succession planning, and other HR activities in conjunction with the AP country Medical/Regulatory Directors.
• Develops and maintains motivated and competent staff through personal attention, and by negotiating appropriate development and advancement measures to the Head of GRA Asia as well as with regional and local Business Management as needed.       
• Contributes to the  achievement of AP regional business and development goals by aligning AP regional regulatory strategy and achieving regional regulatory goals.
• Ensures  achievement of regional business goals by coordination of timely and high quality CTA and NDA/MAA submissions and by obtaining on-time marketing authorizations (including major variations and labeling changes).
• Responsible for alignment of regional project prioritization with global planning.
• As core member of the GRA Asia Management Team, ensures that the overall strategic objectives of the GRA Asia organization are met within the Region (delivery of predictable highest quality approvals on time and maintenance of approvals in full regulatory compliance).
• As core member of the GRA Asia Management Team, actively contributes to implement tools to ensure effective communication between the Regional Offices and GRA C&OI.
• Responsible for regulatory strategy decisions on a regional basis as a basis for business decisions.
• Ensures implementation of global labeling processes.  Maintains an oversight of labeling in the Region, and communicates any issues that arise concerning global labeling processes.  
• Ensures optimal development times and quality first cycle approvals with competitive labeling within the assigned region and in close interaction with the Regional country RA heads as well as the wider GRA Asia organization, through creation and implementation of appropriate regulatory product development strategies and Health Authority buy in of these strategies
• Together with the Head of GRA Asia, participates in key meetings with Health Authorities within the assigned region.
• Together with the Head of GRA Asia, interfaces with regulatory officials and medical opinion leaders to optimally position BSP as a key partner within the region.
• Provides and ensures internal consulting within the region and to GRA on regional regulatory issues, regulations and interpretation of guidelines.  Works closely with Global Regulatory Strategists and RA Heads of China, Japan, and Korea, to ensure consistency and compatibility of regulatory strategies through-out the greater Asian (ASEAN+, China, Korea, and Japan) region as well as globally.
• Anticipates, communicates, and influences changes in regulations, guidelines, points to consider, etc. that may affect the approval of new drugs or current marketed drugs in the region
• Directs regulatory compliance activities in the assigned region. Works with Head of GRA Asia as well as GRA C&OI group to ensure regulatory compliance in the region according to local regulatory requirements and to internal requirements (e.g. SOPs).
• Partners with the regional commercial groups and management to ensure that products are developed in such a way as to have optimal market penetration.

Requirement：

• PhD, MD, DVM or PharmD, or equivalent doctoral degree in a biomedical  science with 10 years industry experience, of which 5 years include global regulatory experience or local regulatory line management experience in a highly drug-regulated country.  
• Or:  MS or equivalent degree in a biomedical science with 12 years industry experience, of which 7 years include global regulatory experience or local regulatory line management experience in a highly drug-regulated country.    
• Or:  BS or equivalent degree in a biomedical science with 14 years industry experience of which 9 years include global regulatory experience or local regulatory experience in a highly drug-regulated country.
• Scientific and technical expertise, including the ability to develop and oversee robust regulatory plans covering all phases of drug development. Strong analytical regulatory skills
• Excellent oral and written communication skills, including oral and written fluency in English.  Significant ability in Mandarin Chinese would also be helpful, because of position location in Beijing.
• Strong management and leadership skills. Demonstrated cross-functional communication, interpersonal, influence, and negotiations skills.
• Demonstrated originality in problem solving as applied to drug Regulatory issues.  Skills and experience in dealing with global drug Health Authorities and creating effective Regulatory networks.
• Ability to lead and oversee a globally dispersed dynamic, energized and creative work team in a complex matrix organization.
• The incumbent must provide the team with clear vision, direction, and purpose.
• Ability to focus on multiple issues at one time, ability to organize and direct diverse activities in a changing environment often under time pressure.
• Sensitivity to the diverse cultures comprising the Regional and Global Regulatory Environments.
• Thorough knowledge of company policies and procedures in drug development and maintenance.
• Knowledge of international (ICH, WHO) and national (EU, US, and countries of the assigned region) drug regulations and guidance documents.
• Good project-management ability