Linthwaite, Huddersfield (Hybrid working)
About the Company:
Thornton & Ross, part of the STADA group, are one of the UK's fastest-growing, leading producers of household pharmaceutical products & own some of the country's most loved brands such as,, as well as the leading disinfectant. Many people in the UK will have a product from Thornton & Ross somewhere at home. We are also a trusted & reliable provider of prescription products, including emollients, bone health products & generics to the NHS with over 100 years’ heritage behind us and we have ambitious growth plans over the next 3 years.
Role Purpose:
We are looking for an experienced and enthusiastic Regulatory Affairs professional to join a dynamic team where you will take ownership of a portfolio of diverse projects, help strengthen ways of working in the team and with business partners and support the development of colleagues within the Regulatory function.
Given the broad portfolio of products at T&R, you will have the opportunity to work on OTCs, generics, biosimilar and orphan medicines. The role will mainly relate to new registrations, however there will be some post-launch and compliance activities to support.
This role is key in supporting the delivery of our strategic vision of Caring for People as a Trusted Partner. On a day-to-day basis you will:
1. Work with key partners across the business as the Regulatory lead on high profile licenced medicines projects including NPD and key maintenance initiatives.
2. Support new and existing product maintenance by preparing comprehensive regulatory strategies, aligning stakeholders, and delivering projects in line with agreed business plans.
3. Engaging with regulatory authorities and trade associations.
4. Performing dossier review/gap-analysis in support of product acquisition.
5. Preparing and submitting dossiers to achieve timely authority approvals.
6. Provide Regulatory support on our Biosimilars and Speciality product portfolio.
About You:
At STADA we talk about diversity as Uniqueness. Everyone is unique and we recognise our differences as a strength. Our values Entrepreneurship, Integrity, Agility and One STADA ensure our uniqueness thrives, enabling us to care for people’s health as a trusted partner. Empower your Uniqueness, bring your whole self to STADA.
If you’re keen to add value and see results and enjoy working in a fast-paced environment and have the can-do spirit that’s spearheading our success, bring those unique qualities, with the following skills and qualifications:
7. A relevant Life Sciences Degree or substantial experience
8. Several years solid medicines Regulatory work experience including managing the registration and life-cycle management of product files. Experience with MAAs and variation procedures for the UK/EU market (national and MR/DC) including eCTD dossier preparation and publishing and submission.
9. Experience with document management systems (e.g. FirstDoc/Docuentum), publishing software (e.g. docuBridge) and licencing databases/submissiom portals e.g. CESP/MHRA
10. A self-starter who can work on your own initiative with strong project management skills.
11. Well developed understanding of the commercial drivers and regulatory strategies and registration routes.
12. Strong communication and influencing skills and able to partner effectively with a wide variety of global stakeholders.
What’s in it for you?
Rewarding our employees is important to us, which is why we offer a range of fantastic benefits, such as:
13. An opportunity to further develop your medicines Regulatory experience supporting our growing Biosimilars and Speciality portfolios.
14. A recently renovated work environment based in the Colne Valley (Huddersfield).
15. 25 days annual leave (plus bank holidays) and the opportunity to buy an additional 5 days leave.
16. Hybrid working options
17. Company Pension Scheme.
18. Life Assurance (up to 3 x annual salary).
19. Annual company & performance-based bonus for all employees.
20. Discounted bus & rail travel throughout West Yorkshire and the surrounding area.
21. Free on-site parking with electric vehicle charging points.
22. Reimbursement of professional fees, where essential to the role.
23. We promote good physical and mental health and can provide additional support to our employees via our Employee Assistance Programme all year round.
#LI-LD1