Director - Regulatory Strategist - Quintiles - Singapore

Job description
RESPONSIBILITIES
Participates in and supports business development initiatives in Asia Pacific
Interacts closely with clients to understand their needs with respect to drug development
Leads discussions with clients on regulatory strategies pertaining to Asia Pacific by mapping out the geographic regulatory landscape, and identifying key regulatory issues critical for successful execution of the strategies
Together with clients develop sound and implementable regulatory strategies for Asia Pacific countries

Anticipates and communicates with clients on significant regulatory developments in Asia Pacific.
Enhance and further develop regulatory intelligence in Asia Pacific
Provides regulatory thought leadership in forums like conferences, seminars and industry discussion groups

Desired Skills and Experience
REQUIREMENTS

At least 10 – 15 years' of regulatory affairs experience gained working in a CRO and/or pharmaceutical industry
Has significant exposure to regulatory environment in Asia Pacific preferably in a regional capacity
Advanced knowledge and ability to understand implications of regulatory developments
In-depth knowledge of role of regulatory in drug development including clinical development, market authorization, orphan drug status and post approval commitments in Japan
An acute awareness of changes in the regulatory environment and how these changes implicate on the Asia Pacific and global regulatory environment
Excellent verbal and written English communication skills, with the ability to collaborate with regulatory and other functional teams across cultural and geographic boundaries
The ability to project a professional demeanor and be a respected and credible partner for clients, external thought-leaders and health agencies.
Strong leadership skills in being able to lead regulatory discussions in a virtual global project team and to synthesize the final regulatory strategy
Strategic thinker, with the patience to overcome complexity and the ability to challenge the status quo

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