Regulatory Labelling Manager

Aspire Pharma Limited; Cambridge; On-site; GBP 45,000 - 65,000; Full time

Job summary

Aspire Pharma Limited seeks a Regulatory Labelling Manager to oversee labelling strategy and compliance for pharmaceutical products. This role involves managing labelling documents and ensuring clear communication with regulatory bodies, contributing to the safety and efficacy of medicinal products. Join a dynamic team committed to patient health and innovation!

Benefits

Generous Pension Scheme

Life Assurance cover

25 days holiday plus Bank Holidays

Learning and Development opportunities

Excellent opportunities for progression

Fantastic company events throughout the year

Qualifications

• Minimum of 3 years in regulatory affairs focused on labelling.
• Extensive experience with UK and EU labelling requirements.
• Strong scientific background to interpret clinical and safety data.

Responsibilities

• Develop and implement labelling strategies and manage maintenance.
• Lead the development of core labelling documents and submissions.
• Coordinate internal review processes for labelling documents.

Skills

Attention to detail

Communication skills

Project management

Regulatory compliance

Education

Bachelor's degree in a life science, pharmacy, or related scientific discipline

Tools

Regulatory information management systems

Document management software

Job description

Competitive Salary & Company Benefits| Ideally located close to Petersfield or Leicestershire

Monday to Friday, 9.00am - 5.00pm (potential for flexibility on start/end times based on 7.5hrs/day)

Are you looking to work for a rapidly growing UK Pharmaceutical company, who are passionate about improving patients’ lives across the world?

Aspire Pharma is an asset-light pharmaceutical manufacturer. It licenses and develops niche pharmaceutical products that offer innovative formulations, value for money for payors, and reliable supply arrangements in markets which are often underserved. The business has a highly diversified portfolio of more than 250 products across a number of categories, including branded specialty products and unbranded niche generics in therapeutic areas such as urology, ophthalmology, CNS and dermatology.

Do you want to be part of the journey?

If so, here is your chance!

The Role

The Regulatory Labelling Manager is responsible for the strategic development, authoring, review, and approval of labelling for medicinal products for human use throughout their lifecycle. This includes ensuring compliance with all applicable global, regional, and local regulatory requirements (e.g. MHRA, EU and non-EU national health authorities), company policies, and scientific accuracy.

What will you be doing?

You will lead labelling projects, collaborate cross-functionally, and manage a team to deliver high-quality, compliant, and timely labelling documents that support product registrations, post-approval changes, and patient safety.

Key Responsibilities Include:

• Develop and implement comprehensive labelling strategies for new product registrations (MAA), line extensions, and post-approval changes, considering global regulatory requirements and commercial objectives
• Manage the ongoing maintenance of approved labelling, including safety updates, new efficacy data, and regulatory changes.
• Lead the development and authoring of core labelling documents, including UK and European Product Information
• Prepare and manage the labelling components of regulatory submissions to health authorities worldwide, ensuring that labelling aligns with product strategy and regulatory requirements.
• Coordinate and facilitate the internal review and approval process for all labelling documents with relevant stakeholders (e.g. Medical Affairs, PV/Safety, R&D, Commercial, Marketing, Legal).
• Act as the primary labelling subject matter expert within project teams and cross-functional working groups.
• Ensure all labelling activities are conducted in accordance with company SOPs, regulatory guidelines, and Good Documentation Practices (GDP).

The Person

• Bachelor's degree in a life science, pharmacy, or related scientific discipline.
• Minimum of 3 years of progressive experience in regulatory affairs with a significant focus on labelling for medicinal products for human use.
• Extensive experience with global labelling requirements, including UK (MHRA), EU (EMA), and other major international markets.
• Proven track record of successful authoring, review, and approval of core labelling documents (SmPC, PIL, Labelling).
• Experience with different therapeutic areas is a plus.
• Strong scientific background with the ability to critically review and interpret complex clinical and safety data.
• Excellent written and verbal communication skills, with the ability to articulate complex regulatory concepts clearly and concisely.
• Exceptional attention to detail and accuracy.
• Proven ability to lead projects, manage multiple priorities, and meet tight deadlines in a fast-paced environment.
• Strong interpersonal skills with the ability to build effective relationships and influence stakeholders at all levels
• Proven leadership and team management skills.
• Proficiency in regulatory information management systems and document management software

Why join us?

• As well as a fantastic, inclusive company culture, where employees are truly valued and a competitive salary, we also offer an ever-improving benefits scheme to support your physical and mental well-being which include:
• Generous Pension Scheme.
• Life Assurance cover and Employee Assistant Program.
• 25 days’ holiday plus Bank Holidays.
• Learning and Development opportunities.
• Excellent opportunities for progression.
• Fantastic Company events and celebrations throughout the year.