We are currently looking for a Head of Regulatory Affairs to oversee the APAC region for an established MNC in the Health industry. This person will be in charge of the strategy for the region and oversee all regulatory affairs activities.
Main responsibilities:
- Responsible for defining and implementing regulatory strategies and submissions in support of new and existing products
- Identify risks, develop mitigation plans and communicate to relevant stakeholder in a timely manner
- Evaluate current regulatory processes/procedures and identify and implement improvements consistent with Strategy/Process Excellence Principles
- Develop and maintain current regulatory knowledge and keep abreast of regulatory procedures and changes, interpret regulations, give regulatory insight, advice and support to other departments
- Build strong connections with regulators and industry associations
- Interface with Business Functions
- Represent Regulatory Affairs on cross-functional project teams
- Contribute to short and long-term planning for the business
Requirements:
- Bachelor's Degree in science related field
- 10+ years of experience in Regulatory Affairs in Medical Devices in APAC
- 4+ years' experience in people management
- Strong interpersonal and communication skills.
- Ability to effectively negotiate and influence upper management, affiliates, Regulatory agencies, and industry to ensure that regulatory and business needs are met
- Strong analytical, problem solving, decision-making, and leadership skills
- Capable of managing complexity across the business to consistently deliver expectations while meeting internal and external requirements
- Experience working in a cross-function team environment and managing multiple countries/markets with diverse environment
