Regulatory Specialist

SFI Health; Wigan; On-site; GBP 45,000 - 65,000; Full time

Benefits offered by this job

Annual leave

Birthday off

Pension scheme

Sick pay

Employee discounts

Long service

Recognition programme

LinkedIn Learning

International environment

Diversity culture

Professional development

Job summary

SFI Health is seeking a Regulatory Specialist to manage regulatory activities across EMEA, including product registrations, lifecycle management, regulatory writing and technical documentation. The role ensures compliance with MHRA, Swissmedic, GMP, GDP and applicable European regulatory requirements for the pharmaceutical and nutraceutical portfolio.

You will own registrations, prepare dossiers, liaise with authorities, and support audits while maintaining regulatory costs within budget.

Qualifications

• Bachelor’s degree in pharmacy, pharmaceutical sciences, life sciences, or related discipline.
• Knowledge of MHRA, EMA and other EMEA regulatory frameworks.

Responsibilities

• Own registrations, renewals, variations and lifecycle management across UK, EU and global markets.
• Prepare, review and maintain regulatory dossiers and technical files.
• Undertake regulatory writing for product documentation.
• Prepare submissions in eCTD and liaise with MHRA and regulatory authorities.
• Research and interpret relevant legislation and regulatory guidance.
• Assess regulatory impact of new products and changes on portfolio.
• Review formulations for regulatory compliance for pharmaceuticals and nutraceuticals.
• Support audits, inspections and regulatory enquiries as required.

Skills

Regulatory knowledge

Lifecycle management

eCTD submissions

Regulatory writing

Stakeholder management

Education

Bachelor's degree in Pharmacy

Tools

Regulatory portals

Job description

At SFI Health, we believe we have the responsibility to bring proven natural health solutions to people’s healthcare needs. We are a global natural health company committed to sourcing and producing natural medicines to the highest standards. Backed by evidence of effectiveness, quality and safety, our products are marketed around the world using our international community of leading life sciences companies and distributor networks.

To find out more, please visit https://www.sfihealth.com/

Your new role

We are looking for an experienced and detail-oriented Regulatory Specialist to manage regulatory activities across EMEA, including product registrations, lifecycle management, regulatory writing, formulation review, technical documentation and compliance.

The primary purpose of this role is to ensure compliance with MHRA, Swissmedic, GMP, GDP and applicable European regulatory requirements across the company’s pharmaceutical and nutraceutical portfolio.

Key Responsibilities:

• Own the medicinal product registrations, renewals, variations and lifecycle management across UK, Switzerland, EU, MENA and selected ASIA markets.
• Prepare, review and maintain regulatory dossiers and technical files.
• Undertake regulatory writing for product and regulatory documentation.
• Prepare submissions in eCTD and other required formats & liaise directly with MHRA, Swiss medic and other regulatory authorities.
• Research and interpret relevant legislation, regulatory guidance and industry requirements.
• Conduct regulatory assessments for new products, product changes and existing products & their impact on the company's product portfolio.
• Identify potential regulatory risks and provide practical recommendations to internal stakeholders.
• Review product formulations/recipes, ingredients and specifications to assess regulatory compliance for pharmaceuticals, herbal medicines and nutraceuticals.
• Support maintenance of the company’s Manufacturing and Wholesale Dealers Authorizations with Quality Teams (QA) and Responsible Person (RP)
• Participate in and support audits, inspections and regulatory enquiries where required.
• Maintain an overview of costs compared to budget.
• Support customer service enquiries and Pharmacovigilance activities when requested

Qualifications:

• Bachelor’s degree in pharmacy, Pharmaceutical Sciences, Life Sciences, Bio-Science Chemistry, Biotechnology or related discipline.
• Knowledge of MHRA, EMA and other EMEA regulatory frameworks

Experience:

• Minimum 3 years' experience in Regulatory Affairs & Quality Department; preferably within healthcare, pharmaceutical, food supplement, nutraceutical, natural health or a related regulated manufacturing environment.

Skills:

• Strong understanding of regulatory requirements and lifecycles.
• Strong knowledge of pharmaceutical and healthcare regulatory frameworks.
• Familiarity with eCTD compilation, regulatory agency portals and submission gateways.
• Ability to manage multiple projects and deadlines efficiently.
• Knowledge of data integrity principles and GxP regulations.

Why Join Us?

This is an excellent opportunity for a regulatory professional looking to develop their career within an international healthcare manufacturing environment. You will have the opportunity to work independently across different functions and play an important role in ensuring our products meet the required regulatory and quality standards.

If you are detail-focused, technically minded and passionate about regulatory compliance, we would love to hear from you.

What We Offer

• 24 Days Annual Leave + Bank Holidays
• Birthday day off
• Company pension Scheme
• Company sick pay
• Employee discounts & perks
• Long-service rewards
• Reward & recognition programme
• Access to LinkedIn Learning
• International Working Environment
• Inclusive & Diverse Working Culture
• Opportunities for professional development and learning