Regulatory Operations Manager, Essential Home
Essential Home
With a trusted portfolio of world-class Air Care, Surface, Laundry and Pest Control products, the Essential Home team’s purpose is to Make a House Your Home. Fuelling this newly formed business and leadership team is a diverse and inclusive culture for all. Together, we’re shaping a team with a founder mentality: that listens and learns, and that is entrepreneurial, agile, and action oriented.
With high-quality brands such as Air Wick, Cillit Bang, Calgon and Mortein, now is an exciting time to join a dynamic company full of purpose, pace and energy, that will create a truly unique learning and career opportunity for all.
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
As a Regulatory Operations Manager for Essential Home (ES), you will be responsible for the content of dossiers and dossier packages and will ensure timely compilation, preparation of relevant part of dossiers and packages to support variation and registration changes in the launch and post launch of product lifecycle. You will ensure operational excellence of your area of responsibility and will align on priorities and resourcing with the RAS Director EH.
Your responsibilities
- Responsible for the creation and delivery of regulatory dossiers, driving consistency & direction and guaranteeing the appropriate resources and expertise is applied in line with the agreed regulatory strategy to achieve in market registrations/launches as per planned timings and existing pipeline compliance.
- Manage complex and diverse set of regulatory requirements and landscape overview across multiple markets
- Ensure your teams work in collaboration with other X-functional technical functions like Safety, Quality and R&D as well as other RAS areas and local teams to define documentation requirements and data gathering.
- Drive efficiency to deliver on EH business ambitions.
- Ensuring through dynamic resourcing 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.
- You will be ensure your team:
- review and input into relevant data to maintain and deliver best in class regulatory dossiers and launch packages according to regulatory requirements
- Create and collate market specific documentation where applicable
- Assembly of safety parts of general product files
- Quality checks to ensure compliance with requirements and drive content consistency.
- Develops and inputs into dossier score cards where applicable
- Provide 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
- Bachelor of Science (BSc) / Master of Science (MS) degree in a relevant scientific discipline – such as Chemistry, Biological Sciences, Microbiology, Pharmacy, alongside significant applied industry experience. A PhD degree is a benefit but not a requirement.
- You bring significant prior experience in regulatory affairs (detergent/biocide/disinfectant/general/etc.), with a strong track record of successful projects delivered.
- Experience in creating and maintaining biocide and disinfectant dossiers and supporting documentation.
- You have the knowledge and understanding of global product development and maintenance for EH products, rules, regulations and guidelines current and emerging impacting dossiers/regulatory file maintenance
- Ability to consistently deliver to time, cost and quality standards in a high pressure environment.
- Ability to anticipate future trends accurately and has a broad knowledge and perspective on regulatory implications in the medicines area and has the ability to adapt them to regulatory operations linked with dossier generation and maitenance
- Ability to translate complex regulatory information into a compelling stakeholder friendly language.
- You have strong intellectual curiosity with an appetite for exploring new and previously unchartered territories and an openness to change with ability to think out of the box
The skills for success
What we offer
Equality
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