At a Glance
- Tasks: Coordinate global renewal applications and safety reporting for our trusted medicinal brands.
- Company: Join Haleon, a purpose-driven consumer health company with bold ambitions.
- Benefits: Gain valuable experience in regulatory affairs with a supportive team culture.
- Other info: Inclusive workplace committed to diversity and personal growth opportunities.
- Why this job: Make a real impact on everyday health while developing your professional skills.
- Qualifications: Basic understanding of Regulatory Affairs and strong attention to detail required.
The predicted salary is between 40000 - 50000 € per year.
Welcome to Haleon. We’re a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we’ve grown, evolved and are now entering an exciting new chapter – one filled with bold ambitions and enormous opportunity. Our trusted portfolio of brands – including Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum® – lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science.
The objective of the Product Lifecycle Management (PLM) team is to co-ordinate and deliver the timely preparation of global renewal applications and safety reporting (ie PBRERs and RMPs) for the Haleon portfolio as quickly and efficiently as possible once the required data & documents are available from relevant sources, such as R&D, sites or reference markets.
This role will partner with the business to deliver robust strategic and successful regulatory outcomes for the medicinal portfolio to enable committed business plans with the ability to make independent judgment and decisions in their area of responsibility.
Key Responsibilities:- Prepare/ensure availability of high-quality documents required to support maintenance activities of product licences are completed globally, for: Renewals, Safety Reports (ie PBRERs and RMPs), Licence Cancellation Requests.
- Manage the execution and delivery, with close attention to detail, of ‘Right First Time’ dossiers, ensuring filings for planned initiatives are completed as planned and in accordance with market data requirements.
- Partner with all associated stakeholders, i.e. CMC, Category, Clinical, Medical, Safety, Local Regulatory to manage the execution and delivery of ‘Right First Time’ dossiers, ensuring filings for planned initiatives are completed as planned and in accordance with market data requirements.
- Support Market Specific Requirements and legal type documents which are applicable for all types of submissions. e.g. Power of Attorneys, Letters of Authorisation, Certificate of Pharmaceutical Products, Certificate of Free Sale, other supporting Regulatory Statements and arrange legalisation with Foreign Office/Embassies as required.
- Display ability to minimize impact by communicating and escalating to peers and senior management when required.
- Comply with relevant Regulatory SOPs and systems.
- Act as Regulatory representative on project teams, as required, understanding and applying project management tools.
- Support processes to improve ways of working /communication.
This is a role that requires a basic understanding of what Regulatory Affairs is and how this fits within the lifecycle of a product.
Haleon are committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands every day. It guides us in creating an inclusive culture, where different backgrounds and views are valued and respected – all in support of understanding and best serving the needs of our consumers and unleashing the full potential of our people.
It’s important to us that Haleon is a place where all our employees feel they truly belong. During the application process, we may ask you to share some personal information, which is entirely voluntary. This information ensures we meet certain regulatory and reporting obligations and supports the development, refinement, and execution of our inclusion and belonging programmes that are open to all Haleon employees. The personal information you provide will be kept confidential, used only for legitimate business purposes, and will never be used in making any employment decisions, including hiring decisions.
If you require a reasonable adjustment or 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 adjustments you are requesting. We’ll provide all reasonable adjustments to support you throughout the recruitment process and treat all information you provide us in confidence.
The Haleon recruitment team will contact you using a Haleon email account (@haleon.com). If you are not sure whether the email you received is from Haleon, please get in touch.
Regulatory Associate FTC 6 months employer: Gsk
At Haleon, we pride ourselves on being a purpose-driven employer that champions everyday health through our renowned portfolio of trusted brands. Our Weybridge location fosters a collaborative and inclusive work culture, where employees are empowered to grow and innovate within a performance-focused environment. With a commitment to employee development and a strong emphasis on diversity and belonging, Haleon offers a unique opportunity for individuals seeking meaningful and rewarding careers in the healthcare sector.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Associate FTC 6 months
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those already at Haleon. A friendly chat can open doors and give you insider info on the role.
✨Tip Number 2
Prepare for the interview by understanding Haleon's mission and values. Show us how your skills align with our purpose of delivering better everyday health with humanity.
✨Tip Number 3
Practice common interview questions related to regulatory affairs. We want to see your critical thinking and problem-solving skills in action, so be ready to share examples!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed and shows us you’re serious about joining our team.
We think you need these skills to ace Regulatory Associate FTC 6 months
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Regulatory Associate role. Highlight your relevant experience in regulatory affairs and how it aligns with Haleon's mission of delivering better everyday health.
Showcase Your Attention to Detail:Since this role requires managing high-quality documents and ensuring 'Right First Time' submissions, emphasise your meticulous nature. Share examples from past experiences where your attention to detail made a difference.
Demonstrate Your Team Spirit:Haleon values collaboration, so let us know about your experience working with cross-functional teams. Mention any partnerships you've had with stakeholders like R&D or Clinical teams to show you can work well with others.
Apply Through Our Website:We encourage you to apply directly through our website for the best chance of success. It’s the easiest way for us to receive your application and ensures you’re considered for the role!
How to prepare for a job interview at Gsk
✨Understand Regulatory Affairs
Before your interview, make sure you have a solid grasp of what Regulatory Affairs entails, especially in relation to product lifecycle management. Familiarise yourself with key terms like PBRERs and RMPs, as well as the specific responsibilities outlined in the job description.
✨Showcase Attention to Detail
Given the emphasis on 'Right First Time' dossiers, be prepared to discuss examples from your past experiences where your attention to detail made a significant impact. Highlight any processes you've improved or how you've ensured compliance with regulatory standards.
✨Prepare for Stakeholder Collaboration
This role requires partnering with various stakeholders. Think of instances where you've successfully collaborated with different teams, such as R&D or Clinical. Be ready to explain how you navigated challenges and ensured effective communication.
✨Demonstrate Your Problem-Solving Skills
The ability to minimise impact by communicating and escalating issues is crucial. Prepare to share specific examples of how you've tackled problems in previous roles, particularly in high-pressure situations, and how you communicated those solutions to your team.
