Site Name: Singapore - Rochester Park
Posted Date: Mar 3 2023
WHY HALEON Our purpose is to deliver better everyday health with humanity. #HelloHaleon Hello. We\xe2\x80\x99re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we\xe2\x80\x99re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands \xe2\x80\x93 including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum \xe2\x80\x93 through a unique combination of deep human understanding and trusted science. What\xe2\x80\x99s more, we\xe2\x80\x99re achieving it in a company that we\xe2\x80\x99re in control of. In an environment that we\xe2\x80\x99re co-creating. And a culture that\xe2\x80\x99s uniquely ours. Care to join us. It isn\xe2\x80\x99t a question. This is an exciting time to join us and help shape the future. It\xe2\x80\x99s an opportunity to be part of something special. JOB PURPOSE: To achieve timely patient access to medicinal products through efficient registration and encourage proper use of the medicines and positive patient outcomes through scientific excellence and professional dissemination of information to healthcare professionals. KEY RESPONSIBILITIES: Local Regulatory Affairs:

• Understanding of legal and technical requirements for drug registration
• Application of important and relevant international guidance viz. ICH stability requirements, ASEAN technical requirements on stability, process validation and bioequivalence studies
• On-the-job training \xe2\x80\x93 submission of new application/variation
• Medical advertisement control

Global Regulatory Affairs (Intel and Policy):

• Understand GSK CH Global Regulatory Intel and Policy (GRIP) function, 9-box external engagement framework and external engagement tools & assets (e.g. policy papers, heat map, SWOT and action plan).
• Perform regulatory intelligence monitoring activity (scan, interpret and communicate), including drafting of REGULUS posts
• Participate in Global Regulatory Intelligence Network (GRINs) and Global Regulatory Education Forums (GREFs)

Quality Assurance:

• Quality oversight in organization (from product inbound receiving up to market distribution)
• Technical Terms of Supply or Quality Assurance Agreement with manufacturing site
• Product Complaint handling / product defect reporting
• Product incident management / Recall execution

LEARNING OUTCOMES: You will be able to: At the end of the 11-week training programme, the PRP will achieve the following:

• Interpret the Health Products Act (from the amalgamation of the Medicines Act, the Poisons Act) and the Medicines (Advertisement & Sale) Act;
• Understand and apply the ASEAN and ICH Common Technical Document format requirements in regulatory submissions;
• Understand, apply and fulfil the Singapore medicinal product, medical device, cosmetic and complementary medicines regulatory requirements in regulatory submissions;
• Understand and apply the artwork development system for the development of printed components;
• Understand and be able to chart regulatory activities that are needed to support source switch/ new product launch Understand the Quality System elements expected of a commercial sales and marketing establishment by the Health Sciences Authority (Product Complaint Handling, Product Recall, Good Distribution Practices);
• Understand and apply the process for the development, review and approval of scientific and unbiased promotional materials that facilitate communication with healthcare professionals and the lay public; Understand and apply the process to manage enquiries from the public and healthcare professionals.

INTERESTED? Prior to shortlisting, we will be dropping you a call to ask for your personal information and why you want to work for us. We recommend you apply as soon as possible, because we accept ongoing applications and offer positions on a first come, first served basis. At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We\xe2\x80\x99re striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We\'re striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon\xe2\x80\x99s compliance to all federal and state US Transparency requirements.