Regulatory Ops Specialist - Cosmetics
We are Reckitt
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.
About the role
The Regulatory Operations Specialist plays an essential role in a team that works across the relevant classification regulations to deliver high quality registration packages efficiently. You will ensure appropriate levels of detail within the files for internal purposes, external registrations, 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 enable regulatory operations delivery of global projects and programs for our existing brands by providing key skills and expertise in dossier creation.
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.
Your responsibilities
- Responsible for completing regulatory documentation to support new launches and maintenance of existing products (dossier maintenance, compliance post launch, supply projects).
- Work collaboratively within the RAS strategy, local market and intelligence teams, Medical, R&D and commercial cross-functional community to define global dossier requirements and documentation and deliver high quality data packages.
- Highlights of any potential issues, working with the authoring functions and LRA.
- Responsible for delivery of submissions to agreed operations time frames and collaborate across partner functions to ensure timely delivery of all information required.
- Ensuring through dynamic resourcing with the Regulatory Operations Manager / Senior Manager that sections of the dossiers are delivered as per plans and that appropriate and aligned prioritization is implemented. This includes any relevant variations linked with supply and compliance plans for example.
- As expert in regulatory dossier management and registration activities, you will be up to date on external regulatory requirements.
You will be ensuring that you:
- Review and input into relevant data to maintain and deliver best in class regulatory dossiers and data packages according to regulatory requirements.
- Create and collate market specific documentation where applies.
- Perform quality checks to ensure compliance with requirements and drive content consistency.
- Develops and inputs into dossier score cards where applicable.
- Support input into the strategy on dossier/regulatory file.
- Ensure core dossiers/regulatory files are maintained and incorporates changes through the lifecycle to allow efficient roll outs.
The experience we're looking for
You will succeed because ...
- You are keen to deepen your knowledge and understanding in regulatory affairs, dossier creation and global registrations.
- Experience in preparing and submitting dossiers and supporting documentation.
- 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.
- Demonstrates courage and empathy and work collaborative cross-functional, through change by adopting a growth and compliance mindset and inclusive/expansive leadership.
- Ability to communicate complex regulatory information and requirements into a compelling stakeholder friendly language.
- You are passionate about sustainability, have a sustainable growth mindset and will drive solutions around Reckitt’s sustainability goals.
The skills for success
Dossier Preparation and Management, Business Acumen, Commercial Awareness, Scientific Knowledge, Accountability, Regulatory Affairs Knowledge, R&D, Product Lifecycle Management, Intellectual Property, Business Partnership, Collaboration and partnership building, Adapt to changes in technological development plans, Stakeholder Communication, Adaptability and Change Management, Compliance Mindset, Growth Mindset.
What we offer
Equality
Job Segment:
Counseling, Nutrition, Pharmacy, Healthcare