Regulatory Affairs Officer

STADA Arzneimittel AG; Huddersfield; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A pharmaceutical company in Huddersfield is seeking an experienced Regulatory Affairs Officer to manage a diverse portfolio of regulatory projects. The ideal candidate has a degree in Life Sciences and solid experience with Marketing Authorisation Applications. This role offers a competitive salary, hybrid working conditions, and a range of employee benefits including wellbeing support and family leave.

Benefits

Competitive salary and annual bonus scheme

Hybrid working

25 days of annual leave plus bank holidays

Wellbeing support services

Electric Car Scheme

Qualifications

• Experience with Marketing Authorisation Applications and lifecycle management.
• Solid understanding of commercial drivers and regulatory strategies.
• Self-motivated with strong project management skills.

Responsibilities

• Manage diverse portfolio of regulatory projects.
• Develop comprehensive regulatory strategies and align stakeholders.
• Prepare and submit high-quality regulatory dossiers.

Skills

Degree in Life Sciences or equivalent

Solid experience with Marketing Authorisation Applications

Experience with document management systems

Strong project management and organizational skills

Strong communication and influencing skills

Education

Degree in Life Sciences or equivalent

Tools

FirstDoc/Documentum

docuBridge

CESP/MHRA

Job description

About the job

STADA UK Thornton & Ross is on an exciting growth journey with more than 700 employees being fully committed to our purpose of Caring for People’s Health as a Trusted Partner. Together we are shaping the future of Thornton & Ross by living our values of Integrity, Entrepreneurship, Agility and One STADA. If you want to work in an open culture where your uniqueness is valued, join our Regulatory Affairs Team.

Role Purpose

We are looking for an experienced and enthusiastic Regulatory Affairs Officer to join our dynamic team at STADA UK / Thornton & Ross. In this role, you will manage a diverse portfolio of projects, contribute to process improvement initiatives, and collaborate closely with cross-functional partners across the business.

Our Regulatory Affairs team oversees a broad range of product types and classifications, covering OTCs, generics, biosimilar and orphan medicines. This role will primarily focus on Product Lifecycle Management (PLM) for our established portfolio, as well as the delivery of new product registrations and extensions for OTC medicines.

How You Will Make An Impact

As a key contributor to our strategic mission—Caring for People as a Trusted Partner—you will:

• Work with key partners across the business as the Regulatory lead on high profile licensed medicines projects including key maintenance initiatives, NPDs and EPDs.
• Conduct dossier reviews and gap analyses.
• Develop comprehensive regulatory strategies, aligning stakeholders, and delivering projects in line with agreed plans, managing risks accordingly.
• Engage with regulatory authorities and internal and external stakeholders.
• Prepare and submit high-quality regulatory dossiers, ensuring timely approvals; manage RFIs and engage with authorities to resolve any issues.
• Identify areas for process optimisation and lead the implementation of improvements.

What We Are Looking For

At STADA, we embrace Uniqueness—recognising the value that diverse perspectives bring to our work. Our core values—Entrepreneurship, Integrity, Agility, and One STADA—guide how we collaborate and innovate

We’re looking for someone who shares this spirit and brings the following qualifications and skills:

• Degree in Life Sciences (or equivalent) or substantial experience.
• Solid experience with Marketing Authorisation Applications (MAAs) and lifecycle management of regulatory dossiers.
• Experience with document management systems (e.g. FirstDoc/Documentum), publishing software (e.g., docuBridge), and licence databases/submission portals e.g., CESP/MHRA.
• Self-motivated with strong project management and organisational skills.
• Solid understanding of the commercial drivers and regulatory strategies and registration routes.
• Strong communication and influencing skills with the ability to collaborate effectively with global stakeholders.

How We Care For You

At Thornton & Ross our purpose “Caring for people’s health as a trusted partner” motivates us every day. And what would be a better place than starting with our own employees. Which is why we give much in return:

Competitive salary and annual bonus scheme.

Salary Sacrifice Pension Scheme offering 6% employer contribution rates.

Hybrid working – we spend three days of your choice in the office, with the remaining days working at home.

25 days of annual leave plus bank holidays with the potential to buy up to 5 additional days.

Wellbeing support through our Employee Assistance Programme and KYAN Wellbeing – offering free coaching and counselling services for you and your family.

Electric Car Scheme through Octopus Energy, plus free on-site EV charging.

Enhanced Family Leave.

Plus, many more employee benefits & celebration events.

STADA Group values and promotes its diverse culture, regardless of gender, age, social or ethnic origin, disabilities, religion, ideology, or sexual orientation. We use the strength of our uniqueness to develop creative ideas, expand our experience and increase innovative strength. Our focus is on equal opportunities, respectful cooperation, and the promotion of an inclusive working environment. We are looking forward to your application and welcome applications without a pharmaceutical background.