Regulatory Team Leader - Licensed Medicines

Company description:

Thornton & Ross

Job description:

Huddersfield (Hybrid working)

About the Company:

Thornton & Ross, part of the STADA group, are one of the UK's fastest-growing, leading producers of OTC medicines, generics, and have a growing portfolio of biosimilars and specialty medicines. Many people in the UK will have a product from Thornton & Ross somewhere at home. We are a trusted & reliable provider of prescription products to the NHS with 100 years heritage behind us and we have ambitious growth plans over the next 3-5 years.

Role Purpose:

We are looking for an experienced and enthusiastic Regulatory Affairs professional who can take ownership of a portfolio of diverse products and projects you will lead a small team of 3 responsible for end-to-end product lifecycle management, ensuring compliance and maintenance plans are in place for the function, help strengthen ways of working in the team and with business partners, and support the development of colleagues within the Regulatory function.

This role would be ideal for an existing Team Leader with strong medicines regulatory experience looking for a hands-on technical role, while leading a dynamic team. This position is critical in supporting the delivery of our strategic vision ofCaring for People as a Trusted Partner. Your key responsibilities will be to:

• Lead the Product Lifecycle Management team, overseeing workload management and development of your team supporting team members with their professional development.
• Work with key partners across the business as the Regulatory lead on high profile licenced medicines projects - including compliance programmes and NPDs/range extensions.
• Lead the regulatory strategy for all life-cycle management activities - aligning stakeholders and delivering projects in line with agreed business plans.
• Engaging with regulatory authorities to agree submission strategies and resolve issues.
• Prepare and submitting dossiers to achieve timely authority approvals.
• Act as a company representative at industry regulatory meetings.
• Performing dossier review/gap-analysis in support of product acquisition.
• Monitor for changes in legislation and proactively manage impact of these changes on the business.
• Strengthen ways of working withing the Regulatory function, and across the business.

About You:

At STADA we talk about diversity as Uniqueness. Everyone is unique and we recognise our differences as a strength. Our valuesEntrepreneurship, Integrity, AgilityandOne STADAensure our uniqueness thrives, enabling us to care for peoples health as a trusted partner. Empower your Uniqueness, bring your whole self to STADA.

If youre keen to add value, see results, and enjoy working in a fast-paced environment and have the can-do spirit thats spearheading our success, bring those unique qualities, with the following skills and qualifications:

• Ideally a Life Science degree or equivalent.
• Experience of managing direct reports with a strong track record in coaching and mentoring team members and the ability to deliver results through others.
• Experience in the pharmaceutical industry working in a global regulatory team within either a research and development or established products environment.
• Strong working knowledge and experience of applicable EU and UK Regulations, Directives and Guidance across licenced medicines working in a fast paced new product launch environment.
• Well developed communication and influencing skills and the ability to build effective working relationships with both internal and external stakeholders such as the MHRA.

Whats in it for you?

Rewarding our employees is important to us, which is why we offer a range of fantastic benefits, such as:

• A recently renovated work environment based in the Colne Valley (Huddersfield).
• Private healthcare cover.
• Annual bonus scheme.
• 25 days annual leave (plus bank holidays) and the opportunity to buy an additional 5 days leave.
• Hybrid working options (3 days a week on site) and some flexibility to suit employees preferred working pattern based around our core hours.
• Company Pension Scheme.
• Life Assurance (up to 3 x annual salary).
• 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.

ADZN1_UKTJ