Regulatory Compliance Supervisor - Fix Term Contract
Descrizione dell'offerta
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. Now it’s time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose – to deliver better everyday health with humanity – at the heart of everything we do. It unites us, inspires us, and challenges us to be better every day, driven by our agile, performance-focused culture.
The main objective is to coordinate activities with a regulatory impact on a portfolio of products by ensuring regulatory compliance during the lifecycle of the product, participating in projects evaluation and submission strategy.
Key Responsibilities
- Responsible for planning the site’s regulatory activities for the products under his responsibility and for new developments projects. Collaborate with Central Regulatory on the establishment of planned activities (variations, renewals…) and prioritization. Escalate potential issues or delays.
- Ensure timely availability of documentation for planned regulatory submissions and RTQ, act as facilitator between Central Regulatory and plant technical functions (production, technical, engineering and analytical/stability departments) and collaborate with worldwide affiliates for regulatory compliance matters.
- Evaluate regulatory relevance of proposed changes. Participate in change control process from creation, strategy and implementation until closure, represent regulatory point of view at the site’s Change Control Committee.
- Prepare documentation to support layouts/process/personnel flow and equipment changes to be authorized by Health Authorities (e.g. AIFA or ASL) through the collaboration with plant technical functions (production, technical, engineering and analytical/stability departments).
- Prepare documentation to keep updated all plant GMP licences.
- Identify and evaluate gaps as well as propose regulatory remediation and get escalation process under way in case of non-compliance.
- Elaborate SOP and WI for all processes related to team activities and daily tasks.
- Coordinate ways of working with other departments and work on process improvement.
Qualifications And Skills
- Biological sciences, Chemistry, Pharmacy or related scientific discipline
- At least 5 year in a Pharmaceutical Quality Environment Good experience in Regulatory Affairs/CMC Understanding of laboratory techniques
- Good understanding of GMP/HACCP
- English: fluent (oral and written), good presentation skills
- MS Office: good command
- M-ERP, Veeva: good knowledge
- Team player, ability to analyse and attentive to details, good communication and influencing skills, handling of priorities, adaptability.
Job Posting End Date:
Equal Opportunities
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.
Adjustment or Accommodations Request
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.
Note to candidates
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.
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