Regulatory Operations Specialist - Medicines

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.About the role The Regulatory Operations Specialist plays an essential role in a team that works across the medicinal regulations to deliver high quality variation packages efficiently. You will ensure appropriate levels of detail within the files for internal purposes and ongoing maintenance activities throughout the full product lifecycle. You will ensure business agility in manufacture and supply activities and will strive to maintain an excellent level of compliance for our products globally. You will ensure that all regulatory dossier activities are completed according to the best process, in a consistent approach across projects. You will work alongside a wide range of cross functional stakeholders including the RAS Global function, Medical, R&D, Supply, Quality and Marketing.,

• Supporting a complex and diverse set of regulatory requirements and landscape overview across multiple markets to enable dossier maintenance and compliance post launch.
• Responsible for delivery of high quality submissions to agreed operations time frames and collaborating across partner functions to ensure timely delivery of all information required.
• Supporting non dossier maintenance activities e.g. GMP documentation support for any/all of the Reckitt medicinal manufacturing sites globally.
• Ensuring all activities are performed in line with the operating model and internal best practice including the compliant use of all systems to ensure audit readiness at all times.
Key Challenges:
• Working in a fast paced FMCG environment to ensure that a product remains compliant during its lifecycle post approval, with no loss of supply due to a regulatory reason.
• Keeping on top of the ever changing regulatory environment and ensure that all relevant information is applied to all necessary product and dossier updates.
• Meeting business / project deadlines in a pressurised environment.
• Building relationships across Regulatory, the wider R&D community, and supply functions within Reckitt.
  
  You bring prior experience in regulatory affairs and knowledge in dossier creation and global registrations.
• Knowledge of the Regional and Global regulatory environment and how it impacts regulatory dossiers and registrations
• Experience in preparing and submitting dossiers for medicinal registrations and supporting documentation.
• A proven ability to work on multiple projects at any given time and a capability to prioritise and manage your own workload independently and as part of the wider team.
• You have basic knowledge and understanding of global product development and maintenance for Reckitt products, rules, regulations and guidelines current and emerging impacting dossiers maintenance.
• You have scientific credentials with a Bachelor of Science (BSc) / Master of Science (MS) degree in a relevant scientific discipline - such as Chemistry, Biological Sciences, Microbiology, Pharmacy.
• You are a creative, results focused individual with a strong passion for working collaboratively with cross functional teams, built on technical credibility, trust and strong relationships.
• Ability to consistently deliver to time, cost and quality standards in a high-pressure environment.
• You strive for a high level of accuracy in authoring documentation, with a focus on ensuring the level of registered information is appropriate in the dossiers.
• Ability to communicate complex regulatory information and requirements into a compelling stakeholder friendly language.
The skills for success Regulatory, Task Execution Under Pressure, Business Acumen, Commercial Awareness, Objective Setting, Accountability, Consumer Insight, R&D, Product Lifecycle Management, Intellectual Property, Business Partnership, Collaboration and partnership building, Adapt to changes in technological development plans, Ability to challenge the status quo and propose improvement, Innovation Processes.

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.