Regulatory Affairs Specialist
3 days ago
About Thornton & Ross:
Thornton & Ross, a leading pharmaceutical company, is part of the STADA group. We are a trusted provider of household pharmaceutical products and prescription medications to the NHS. With over 100 years of heritage, we have ambitious growth plans and are looking for an experienced Regulatory Affairs professional to join our dynamic team.
Job Purpose:
We are seeking a skilled Regulatory Affairs professional to take ownership of a portfolio of diverse projects, strengthen ways of working in the team and with business partners, and support the development of colleagues within the Regulatory function. The successful candidate will have the opportunity to work on a broad portfolio of products, including OTCs, generics, biosimilars, and orphan medicines.
Key Responsibilities:
- Work with key partners across the business as the Regulatory lead on high-profile licensed medicines projects, including NPD and key maintenance initiatives.
- Support new and existing product maintenance by preparing comprehensive regulatory strategies, aligning stakeholders, and delivering projects in line with agreed business plans.
- Engage with regulatory authorities and trade associations.
- Perform dossier review/gap-analysis in support of product acquisition.
- Prepare and submit dossiers to achieve timely authority approvals.
- Provide Regulatory support on our Biosimilars and Speciality product portfolio.
About You:
We value diversity and uniqueness at STADA. Our values of Entrepreneurship, Integrity, Agility, and One STADA ensure that our differences are recognized as a strength. We are looking for a self-starter with strong project management skills, a well-developed understanding of commercial drivers and regulatory strategies, and strong communication and influencing skills.
What We Offer:
- An opportunity to further develop your medicines Regulatory experience supporting our growing Biosimilars and Speciality portfolios.
- A recently renovated work environment based in the Colne Valley.
- 25 days annual leave (plus bank holidays) and the opportunity to buy an additional 5 days leave.
- Hybrid working options.
- Company Pension Scheme.
- Life Assurance (up to 3 x annual salary).
- Annual company & performance-based bonus for all employees.
- Discounted bus & rail travel throughout West Yorkshire and the surrounding area.
- Free on-site parking with electric vehicle charging points.
- Reimbursement of professional fees, where essential to the role.
- We promote good physical and mental health and can provide additional support to our employees via our Employee Assistance Programme all year round.
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