Regulatory Affairs Specialist, Personal Health JAPAC

3 weeks ago


Petaling Jaya, Malaysia Philips Full time
Job TitleRegulatory Affairs Specialist, Personal Health APAC

Job Description

In this role, you have the opportunity to

Utilize your expertise and knowledge of regulatory in developing and following up closely with the regulatory strategy and deployment within the APAC region for the Personal Health business. You will be part of Personal Health Regulatory Affairs team and be the interface mainly for APAC countries and Personal Health business units. This role will be responsible for supporting a variety of regulatory activities in APAC region. You will maintain regulatory information management system and ensure proper regulatory strategy and deployment for business and marketing team and the required packages and deliverables. You will also translate the regulatory strategy and deployment into consumer needs.

Your role:

  • Responsible for regulatory planning for new product introductions and product changes
  • Responsible for maintaining regulatory compliance
  • Plan, generate and coordinate regulatory submissions for product licensing
  • Maintain existing regulatory filings/ licenses, managing updates and related change control processes
  • Assists with the implementation of global regulatory and roadmaps through understanding the competitive market landscape and product marketing strategy.
  • Develop regulatory strategy, and if needed connect with the regulatory SME’s and make regulatory plans.
  • Proactive stakeholder management for PH Business Units.
  • Develop and facilitate regulatory submissions, for new products and existing products in the region.
  • Other regulatory projects as applicable.

You are a part of

The Personal Health International Market Regulatory & Quality team. Reporting line of this position is to Personal Health Regulatory & Quality Market Lead, and a dotted line reporting to the local Regulatory Affairs Lead. This position partners with business unit’s regulatory leaders, marketing, quality, and distributors where you will guide the related stakeholders in application of all applicable regulatory requirements; ensuring gap analysis, regulatory assessment and impact for a successful regulatory submission and approval in each impacted country.

You could be the right fit if you possess these:

  • Bachelor’s Degree Qualifications
  • 2 - 3 years of regulatory experience in the consumer health industry
  • Ability to understand regulatory environment
  • Ability to understand compliance rules, guidelines and regulations
  • Ability to partner with other areas of Philips
  • Experience in assembling the technical document
  • Ability to interpret applicable regulations to ensure compliance in a changing regulatory landscape
  • Ability to work in a matrix organization and being agile
  • Strong organizational skills, ability to work on multiple projects, and work effectively in a demanding, time-sensitive environment

About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
Learn more about our purpose.

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

By submitting your resume and related information in the manner set out in this job post, you consent for Philips and Philips’ authorized nominee to collect, process, transfer and store your personal data for purpose of the application for the above-mentioned job opportunity. Further, in the event you provide any personal information of another data subject as referee, you confirm that the relevant data subject consented to the disclosure of such personal data to Philips and Philips’ authorized nominee. For more information and details on our Privacy Policy, please visit this link.



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