Regulatory Associate Medicines

Regulatory Associate - UK Medicines

City:
Slough

You will work at the heart of the Northern Europe (UK & Ireland) commercial organisation, collaborating with the relevant cross‑functional teams to ensure the required regulatory activities are identified and completed to enable the successful completion of the project or topic. You will be solution oriented by providing suitable resolutions for projects, issues and other regulatory topics. You will ensure product compliance with all local regulations and Reckitt internal processes.

• Understand the external organisational environment, Reckitt’s position, and how to influence legislation.
• Take (potentially lead) a role in projects, interacting with teams working with RAS, and hold responsibilities for key deliverables.
• Communicate effectively and establish strong business partnerships.
• Create compliant documents and submissions.
• Support the development and roll‑out of new and existing products and identify potential risks.
• Identify continuous improvement ideas, propose solutions and act.
• Work under pressure while ensuring high‑quality task execution and adherence to deadlines.

• Lead on projects, expand the cross-organisational network, and develop strong communication skills demonstrating accountability for deliverables.
• Grow functional expertise and understand how to navigate the complex regulatory and safety landscape.
• Apply knowledge, scientific, and technical skills, alongside experience in new areas to prepare for future progression.

• Regulatory new products development and compliance for Northern Europe products and authorisations, including preparation and submission of changes and renewals to the Regulatory Agencies, as required.
• Ability to use technical expertise, scientific capabilities, and data analysis to problem‑solve.
• Basic knowledge of Regulatory and Safety environment.
• Basic understanding of compliance requirements in consumer goods companies (desired).
• CMC submissions of type I and type II variations (including grouping and work‑sharing), such as site transfers, change of manufacturing processes, FSP and analytical methods.
• Gap analysis of quality dossiers for licensing, including experience in reviewing and quality check of CMC documents for electronic submissions to the Health Authorities.
• Creation and assessment of internal quality and non‑quality changes in line with the change control management system.
• Submission of type II and PRAC safety variations to update SmPC and labelling.
• Artwork review and approvals, including preparation of User Test Reports when required.
• Work collaboratively with the relevant country teams to establish and implement the regulatory strategies within agreed timescales to bring competitive advantage to Reckitt brands.
• Provide support when required to the Vigilance and Quality Teams to ensure compliance with vigilance and quality obligations.
• Interpret and apply all relevant legislation in NEU to keep the Reckitt business up to date on National regulatory trends, risks and opportunities.

• University Science degree in relevant scientific discipline and regulatory experience within OTC industry.
• Thorough understanding of the current UK, Irish and European regulations, laws, guidelines and industry requirements.
• Preferably minimum 2 years CMC experience and submissions of type I and type II variations (including grouping and work‑sharing), such as site transfers, change of manufacturing processes, FSP and analytical methods.
• Exceptional ability to manage workload and identify priority tasks to meet tight deadlines.
• Ability to build good relationships and challenge constructively and confidently.
• Ability to consolidate large volumes of complex information, interpret & construct straightforward plans.
• Confident and capable of resolving conflict situations.
• Competent with PC tools and information systems.
• Ability to challenge the status quo and propose improvement.
• Able to apply appropriate problem‑solving techniques to evaluate and resolve operational issues.

University Science degree,…