Pharmaceutical Associate, Regulatory Compliance Specialist

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City:
Slough

Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose.

Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.

In Research and Development, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance.

We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.

The size of our organisation means you'll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.

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.

Key responsibilities of your role:

• 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.

Role impact and development:

• 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…