Regulatory Affairs Manager
|Job Title:||Regulatory Affairs Manager|
|Contact Name:||CHONG Pei Fen|
|Job Published:||August 02, 2017 16:06|
Our client is a global healthcare product provider, headquartered in the US.
As a result of growth plans in Asia Pacific, there is now a need to hire a Regional Regulatory Affair Manager to be based in their Singapore regional office.
Reporting of the role:
You will report to the Regional RA Director
Responsibilities of the role:
- Contributes to the development of global, regional and/or local regulatory strategies with clear risk assessments and prudent risk taking. Makes recommendations in order to shape the global strategy in line with regional/commercial objectives.
- Work with regulatory colleagues in the markets to develop innovative regulatory strategies for New Products (NPD/NPI) to drive business growth; assist markets in product registration planning, claims assessment and innovation, developing registration dossiers for submission, monitoring the progress, status and timelines
- Partners with the business to deliver regulatory outcomes to enable business plans.
- Works with strategic direction and performs with independent judgment which directly impacts the operational results of the local markets
- Represent Asia Pacific Regulatory Affairs in Regional and Global teams and other related project management meeting to assist in the development and implementation of Regulatory Strategies in line with the Regional Franchise priorities
- Manages functional activities to ensure short and long term objectives are achieved in a proactive, cost and time efficient way.
- Monitors the regulatory environment and provides assessments of the impact of new and changing regulations on the company's areas of interest and participates in driving regulatory reform in specific areas. Keep business informed in a timely manner on emerging regulatory issues and develop strategies to mitigate regulatory risks.
What you will need:
- At least a Bachelor Degree in a Science- related field with more than 5 years regulatory experience
- Good knowledge of APAC and global regulatory landscape affecting OTCs
- Good verbal and written communication skills, including formal presentation skills, with good command of spoken and written English