核心要求：

化妝品注冊法規(guī)經驗，愿意接受涉及牙膏或者醫(yī)療器械方面；或是醫(yī)療器械注冊法規(guī)經驗，愿意接受涉及牙膏方面；

醫(yī)療器械主要涉及公司一些早期探索項目以及可能需要的上市后維護方面。器械主要是II類無源，可能涉及醫(yī)用敷料、口腔器械、物理治療等，取決于具體是看項目開發(fā)的需要，也可能涉及其他類別或者可能的藥械組合。（國產和進口都有）

? Ensure products within scope (incl, devices, cosmetics or toothpaste) can be placed on the market with optimal yet compliant claims, advertising and promotion in line with commercial plans

? Ensure products are maintained and meet internal and external compliance requirements

? Be a productive part of defined local regulatory team, including being a close partner to other stakeholders, eg, marketing/sales within local commercial business, supply chain and quality etc.

? Engage with the external regulatory environment within defined area of responsibility and act as voice of Haleon with local regulators, trade associations and other key external regulatory bodies (if required).

? Work together with regulatory colleagues and other stakeholders to look for opportunities and solutions to challenges

? Provide input into regulatory strategies and process improvement/compliance activities within defined areas of scope

Key Responsibilities

? Manage preparation of new regulatory documents, dossiers and applications to enable new products to be launched and maintained in market, with the correct alignment and compliance to regulations, proactively seeking innovative and rapid path to market

? Analyse regulatory issues and communicate with key stakeholders. Work together to help develop plans to mitigate, so that we can deliver science that is robust and aligned with business needs

? Contribute to the activity of a high performing local teams, including looking for ways to improve the performance

? Build relationships with key stakeholders and represent Haleon in an appropriate manner according to company values, in order to present Haleon policies and strategies

? Manage compliance within defined portfolio/activity streams in line with Haleon expections - support key processes and ways of working (eg, in relation to Haleon CMC, quality, product labeling requirements as well as local regulations)

? Work together with other functions ( eg., marketing, supply chain) to deliver NPD and value engineering projects

? Support the development of the competitive claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated

? Manage impact of regulatory changes within defined scope of responsibility on the business

? Maintain required regulatory compliance databases, systems and processes

? Maintain knowledge on the science of products within defined portfolio

A. Educational Background

List any academic or practical education that must be obtained to be qualified to perform this role.

1. Minimum Level of Education BS, BSc

Area of Specialisation Life science/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering)

2. Preferred Level of Education Masters (MBA, MS, MSc)

Area of Specialisation Regulatory Affairs

B. Job-Related Experience

Describe what experience this position will require the job holder to have obtained in past roles within or outside of the company that would demonstrate a level of proficiency in the stated role.

Minimum Level of Job-Related Experience required 5 to 6 plus years’ experience in Regulatory Affairs preferably with experience cosmetic or medical device, appropriate knowledge in Quality, product development and manufacturing, experience in the review of advertising and promotion, submission of varied regulatory dossiers and direct interaction with the Health Authorities.