Regulatory Affairs Officer

The Regulatory Affairs Officer is responsible for supporting the product registration process primarily within Hong Kong and Singapore, ensuring compliance with regulatory requirements and facilitating timely approvals. This role involves coordinating with various external parties such as regulatory authorities, third party agents, business partners, and conformity assessment bodies (CAB); preparing and submitting documentation, and collaborating with internal teams to ensure adherence to local and international regulations. By maintaining up-to-date knowledge of regulatory changes, the Regulatory Affairs Officer plays a key role in ensuring product approval with the health authorities.

The successful candidate will work in a hybrid environment, splitting time between remote work and in-office duties, as determined by the immediate superior. This role will be based in the Philippines and will collaborate with local and international teams.

KEY RESPONSIBILITIES:  

• Ensure compliance with local and international regulatory requirements for products and services and communicates with business partners to gather documents required for product registration within the required time frame.


• Review and analyze business partner’s documents, using a number of different methods including artificial intelligence (AI), for product registration in compliance with applicable regulations including preparation, submission, and management of regulatory filings, including applications, renewals, and changes.


• Collaborate with cross-functional teams and external agencies to ensure products meet legal, industry and quality management standards whilst monitoring and interpreting changes in regulations to advise the company on necessary adjustments.


• Communicates with regulatory authorities and third-party agents to obtain approvals, resolve issues, and maintain compliance, accurate documentation and records to support audits and inspections.


• Provide guidance and training to teams on regulatory requirements and best practices whilst addressing regulatory inquiries and supporting risk management initiatives.
  

QUALIFICATIONS:

• Bachelor’s Degree in Medical, Life Science or related discipline.


• Minimum of 2 years of combined experience in Regulatory Affairs, preferably with exposure to the healthcare or medical device industry.


• Strong knowledge of licensing and product registration processes and overall regulatory compliance and in handling electronic submissions and regulatory databases


• Familiarity with relevant regulatory frameworks and digital tools e.g. AI, SharePoint, etc. for documentation management.


• Strong proficiency in both written and spoken English, with excellent communication skills for liaising with internal and external stakeholders, highly detail-oriented with an analytical mindset, ensuring accuracy in regulatory documentation and compliance assessments


• Well-organized and capable of managing multiple regulatory processes efficiently, Proactive in problem-solving, with the ability to assess risks and determine appropriate solutions.


• Adaptability to evolving regulatory requirements and the ability to work in a fast-paced environment.