Intern, Regulatory Affairs Operations (PECT)

Descripción del puesto:

Hello. We're Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we're improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum - through a unique combination of deep human understanding and trusted science. What's more, we're achieving it in a company that we're in control of. In an environment that we're co-creating. And a culture that's uniquely ours. Care to join us. It isn't a question.

This is an exciting time to join us and help shape the future. It's an opportunity to be part of something special.

About the role

The NUS Pre-Employment Clinical Training (PECT) Programmed Internship is a collaboration with NUS Singapore Pharmacy School. Haleon offers a wholesome platform for Regulatory Operations Interns under the PECT Programme to come on board for a short-term real-world learning experience. The programme serves to train and nurture students to be ready to step into the regulatory landscape in a leading consumer healthcare industry.

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 - submission of new application/variation
* Medical advertisement control

* Global Regulatory Affairs (Intel and Policy):
* Understand Haleon's 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

Qualifications and skills
Essential
* Completion of Year 3 NUS Pharmacy study programme
* Successfully achieve passing grades for all related modules in NUS without any negative track records
* Previous experience in similar industries is a bonus.

Preferred
* Responsible and Driven attitude
* Ability to collaborate and work with cross functional teams.
* Communications Skills

Learning Outcomes:
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.

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.

Accommodation Requests

If you require a reasonable accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please let your recruiter know by providing them with a description of specific accommodations you are requesting. We'll provide all reasonable accommodations to support you throughout the recruitment process and treat all information you provide us in confidence