Our client is a leading healthcare company looking for a Regulatory Affairs Associate to join their team.

Job Responsibilities

• Ensure to update the current registration file in timely manner.

• Renew and revise the existing product license to ensure all are valid and compliance with regulation

• Maintain currency of labelling, pack leaflets in accordance with local regulations and corporate data sheet.

• Establish good relationship with Health Authority officers.

• Establish good relationship with GRA regional/global regulatory staff for regular contact.

• Provide cross-functional support needs in the organization.

• Participate in workshop, symposium related to regulatory affairs changes; share with other team members the latest information related to his/her works.

• Being able to propose solution to different problem and discuss with his/her Line Manager.

• Perform other duties as assigned by management.

Job Requirements

• Scientific background (Pharmacy or related field)

• Experience in regulatory affairs field is desired

• Proficiency in spoken and written English

• Fast learner, highly organized, detail-minded and able to work independently

• Strong interpersonal and communication skills; demonstrates cooperative attitude both among team members and with other colleagues in the company

• Able to master digital tools & systems

• Shows integrity, tenacity, resilience and adaptability in complex situations; able to handle pressure and commit to and respect deadlines

• Quick to analyze and take action without compromising quality; utilizes effective negotiation skills

• Highly focused and drives to set for him/herself ambitious objectives

• Knowledge and practice in the regulatory field is desired