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Regulatory Affairs Officer – Licenced Pharmaceuticals (Rx)

Linthwaite, Huddersfield

OUR MISSION, YOUR HEALTH

AGILITY – do you have the flexibility and decisiveness to drive change?

ENTREPRENEURSHIP – will you thrive in one of the fastest growing pharmaceutical businesses in Europe?

INTEGRITY – we are driven by trust, respect, and honesty, are you?

ONE STADA – communication and teamwork, it’s our path into the future together.

About the Company:

Like all success stories, our company history started with a great idea. In 1895, a group of pharmacists had a common objective: The standardised production of medicinal products to ensure an effective and reasonable provision of healthcare for the many. This was the beginning of STADA’s impressive development.

As a global and constantly growing health care group, we dedicated ourselves to people’s health and wellbeing. We know that our committed and qualified employees make a key contribution to STADA’s success. With a long-standing heritage rooted in pharmacies, we continue to be a reliable and trustworthy partner.

If you are ready for new challenges where you can make a difference to people’s health, you have come to the right place. We are looking for qualified employees, who drive our company forward with their specialist knowledge and commitment. We offer the right conditions with diverse and interesting tasks as well as good career prospects and a comfortable working environment.

About the Role:

You will be joining a team of regulatory specialists and will report to the Rx Regulatory Team Leader. In this role, you'll be responsible for responsible for the on-going maintenance of T&R’s prescription licenced medicine portfolio (inc. branded (Rx) and generic (Gx)) products and support of new product development (NPD) activities – predominantly for the UK market (national and MR/DC procedures).

As part of a multi-functional team, this role may also involve regulatory support of other business hubs (e.g. non-prescription medicines) as required and the opportunity to gain regulatory experience/expertise in other product categories. This role is key in supporting the delivery of our strategic vision of Caring for People as a Trusted Partner.

Key Responsibilities

• To support the Regulatory Team Leader and wider regulatory team in ensuring that Thornton & Ross, including its various company entities, is fully compliant with its responsibilities for licensed pharmaceutical products.
• To contribute to the regulatory strategy of the company, especially on marketing authorisation applications (MAAs) and maintenance activities (post-approval variations).
• To work with key stakeholders (internal and external) and, as required, to act as the regulatory lead on business projects including NPD/maintenance for licenced medicines.
• To support new MAAs for licenced pharmaceutical products inc. compilation and submission of documentation and dossier review/gap-analysis as required.
• Life-cycle maintenance of existing licenced pharmaceutical products (National & MR/DCP) inc. compilation and submission of post-approval variations in line with the relevant NCA requirements/guidance and in accordance with internal processes.
• As required, to act as the company representative at appropriate industry regulatory meetings, such as the MHRA, BGMA or PAGB.
• Support business development function with regard to NPD regulatory project activities and dossier development where necessary.
• To help ensure relevant departmental procedures and working practices are kept up to date and reflect legislative requirements and best practice.

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, thrive under pressure and have the can-do spirit that’s spearheading our success, bring those unique qualities, with the following skills and qualifications:

• BSc in life science discipline or equivalent.
• Worked in licenced medicines for at least 1-2 years including (ideally):
  • Experience of working on MA applications (inc. dossier gap analysis, module 1 documentation / product information generation) and life-cycle maintenance regulatory activities (National and/or MR/DC procedures). Specific experience with UK licenced medicines / MHRA requirements preferred.
  • Basic understanding of the commercial drivers and regulatory strategies/MAA routes specific to generics/prescription products.
  • Understanding/experience of risk management materials and pharmacovigilance (PV) requirements
  • Use of eCTD dossier storage/publishing software (e.g. FirstDoc/Docubridge)
• Negotiating and influencing skills with key stakeholders inc. active as regulatory lead during multi-functional projects.
• Knowledge/understanding of CMC / CTD requirements

This demanding role requires the following skills/attributes:

• Good attention to detail inc. analytical and numeracy skills
• Project management
• Demonstrates team working within a team and across all departments
• Resilience and determination to succeed inc. ability to deliver against demanding objectives/targets
• Excellent communication inc. negotiation and influencing skills
• Proficiency in MS Word, Excel and PowerPoint etc.
• The ability to develop and progress within the organisation

What’s in it for you?

This is a permanent position with a salary dependant on your skills and experience. With 5 locations in the UK, the STADA UK Head Office is a recently renovated site only a two minute drive from our largest manufacturing site both based in Huddersfield. Zoflora® and Covonia® brands are made locally along with some key medicines for the healthcare sector. We employ over 1000 employees, all of whom have the opportunity to progress as we focus on promoting from within and you can be part of that too. Rewarding our employees is important to us, which is why we offer a range of fantastic benefits, such as:

• A fantastic work environment based in the Colne Valley.
• 25 days annual leave (plus bank holidays) and the opportunity to buy an additional 5 days leave.
• Flexible and hybrid working options with a minimum of 3 days in the office and 2 days remote working.
• 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.