Regulatory Operations Manager

Reckitt Benckiser LLC; Lelley; On-site; GBP 60,000 - 80,000; Full time

Job summary

A global health and hygiene firm is seeking a Regulatory Operations (Medicines) Manager to lead the creation of regulatory safety content and manage a team to ensure compliance across multiple markets. Candidates should have significant regulatory affairs experience, a strong scientific background, and proven leadership skills in fast-paced environments. This position offers the chance to contribute to health and safety innovations and requires a strategic mindset to navigate complex regulations successfully.

Qualifications

• Significant experience in medicinal products regulatory affairs and dossier creation.
• Proven leadership in complex, fast-paced environments.
• Ability to anticipate trends and translate complex regulations.

Responsibilities

• Lead strategy and execution of safety sections in medicines registration files.
• Manage complex regulatory requirements across multiple markets.
• Drive operational excellence in partnership with regulatory operations teams.

Skills

Business Strategy

Task Execution Under Pressure

Strategic Business Decisions

Commercial Awareness

Consumer Insight

Collaboration and Partnership Building

Innovation Processes

Digital Transformation

Education

BSc/MSc in Chemistry, Biological Sciences, Microbiology, Pharmacy

PhD in relevant field

Job description

As Regulatory Operations (Medicines) Manager, you'll lead the creation and delivery of regulatory safety content in medicinal dossiers prioritising for CCDS and PRAC updates, ERA and other safety related documentation which require regulatory submission and lifecycle updates. You'll manage a team of 4-8, oversee external consultants, and collaborate globally with regulatory partners and the RAS Consumer Safety and Risk Management and Vigilance teams as well as with R&D and Quality to achieve market registrations and maintain portfolio compliance.

Responsibilities

• Lead strategy and execution of safety sections in medicines registration files with priority focus on CCDS and PRAC updates.
• Manage complex regulatory requirements across multiple markets.
• Drive operational excellence and in close partnership with RAS Regulatory Operations, Strategy, Consumer Safety and Risk Management and Vigilance teams.
• Ensure dossier accuracy, consistency, and compliance throughout the lifecycle.
• Inspire and develop your team in an inclusive, high-performance environment.
• Ensuring your teams work in collaboration with other cross-functional technical functions like Supply, Quality and R&D.
• Significant experience in medicinal products regulatory affairs and dossier creation.
• Strong scientific background (BSc/MSc in Chemistry, Biological Sciences, Microbiology, Pharmacy; PhD a plus).
• Proven leadership in complex, fast-paced environments.
• Strategic mindset, ability to anticipate trends, and translate complex regulations into clear stakeholder language.
• Passion for sustainability and innovation.

Skills

Business Strategy, Task Execution Under Pressure, Makes strategic Business Decisions, Business accumen, Commercial Awareness, Objective Setting, Accountability, Consumer Insight, Creative Direction, R&D, Change Leadership, Product Lifecycle Management, Intellectual Property, Business Partnership, Collaboration and partnership building, Relationship Management, Adapt to changes in technological development plans, Ability to challenge the status quo and propose improvement, Innovation Processes, Digital transformation for R&D, Quality and Manufacturing.

About Us

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. Research & Development 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.