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Quality Assurance & Regulatory Affairs Manager

Company: iiaa, International Institute for Active Ageing
Location: Head Office and Hemel Hempstead

 

Job description

What’s in it for you?

  • 25 days’ annual leave, rising the longer you stay with us 
  • Three additional holiday days over the festive period 
  • A monthly allowance to spend on our products, plus additional discount
  • Corporate discounts
  • Free annual eye test at Vision Express  
  • Cycle to Work scheme 
  • Recommend a friend scheme: we reward you for bringing people into our business  
  • Season Ticket loan
  • Excellent opportunities to grow and move within the company 

About the role of the Quality Assurance & Regulatory Affairs Manager              

The Quality Assurance & Regulatory Affairs Manager will be responsible for regulatory compliance and quality assurance for our products in the UK and export markets across our food supplements, cosmetics and skincare categories. This includes maintaining all required product documentation and up-to-date registration status to support commercial development and market expansion initiatives.

Main Duties:

Regulatory Compliance

  • Ensure all products meet legal and regulatory requirements in all markets sold (UK, EU, USA, Canada, Australia and other regions) including regulatory dossiers and notifications (including CPNP for cosmetics, food supplements local market notifications, etc).
  • Stay up to date with changes in regulations that affect the sale and development of products and advise the business on how to respond.
  • Maintain a product regulatory database to inform the business of market-specific requirements.
  • Interact with industry groups and regulatory bodies, like HFMA, Department of Trade and EHPM , CTPA , MHRA and more to stay informed and ensure compliance.
  • Work together with other teams to understand how regulatory changes may affect product development, marketing, sale of products and packaging.
  • Ensure product testing meets the requirements of each country we sell in.
  • Technical regulatory support lead for all queries: distributors, corporate clients and internal teams.
  • Ensure annual updates and renewals in place for all SKUs and facilities.
  • Ensure Cosmetic Product Information Files (PIFs) are created, maintained, and accessible in line with EU/UK Cosmetic Regulation requirements.
  • Ensure Responsible Person (RP) obligations are fulfilled for all cosmetics placed on the market in the UK and EU

Ingredient and label integrity

  • Status control and management of raw materials and packing components via C of A’s, MSDS and artwork revisions with sign-offs for product artwork.
  • Due diligence testing to ensure compliance for potency of marker activities and for potential contaminates or other undesirable attributes.
  • Assuring controls for finished products are in place including, finished product specifications, bulk product sample testing by accredited testing labs, assessment of reported results, record keeping and periodic trend analysis along with assessment of C of A’s from sub – contracting manufacturers and packers.
  • Organising and monitoring of stability studies.
  • Technical liaison with suppliers: raw materials, packaging, finished goods and other aspects
  • Monitoring of cost of goods and supplier costs updates with Procurement and Finance teams.
  • Collaboration with Packing Plant teams to ensure production schedules in place for full stock availability.
  • Ensure cosmetic product labels comply with INCI nomenclature, mandatory warnings, country-specific labeling requirements (e.g., PAO symbol, allergens), and are reviewed before launch.
  • Verify compliance with lists of restricted/prohibited substances and permitted concentrations for cosmetic ingredients (e.g., EU Annexes, FDA regulations).

Document and QA Management

  • Ensure world-class SOP management including full documentation control for all SKUs.
  • Creation of technical details and tracker for all packaging artwork as well as new line form details for digital partners.
  • Accountable for the company’s library of product regulatory documents, making sure it’s complete, accurate, and ready for use for all product documentation requirements.
  • Work with other teams to make sure all technical documents, certificates, and product details are correct and aligned.
  • Ensure full compliance with HFMA, EHPM, MHRA, GMP, NSF as well as international regulatory organisations (FDA, Health Canada, TGA Australia and others).
  • Management of GMP Quality Assurance Lead and close collaboration with various internal stakeholders; Packing plant, Logistics, Procurement, Creative and more.
  • Update documents to reflect any new regulations or product changes as and when necessary.
  • Maintain ISO 22716 (Cosmetic GMP) documentation and ensure contract manufacturers of cosmetics adhere to Cosmetic GMP standards.

Export Product Registration

  • Accountable for the process of registering our products for sale in export markets by preparing and submitting the necessary documents and keeping them up to date.
  • Respond to requests for further information within the required timescales.
  • Work closely with the commercial team to make sure product approval (Right to Sell) details are correct and available.
  • Communicate with global regulatory agencies and advisors to handle any questions or changes needed.
  • Ensure all cosmetic notifications and registrations are in place and updated in local and international markets.

Product Development Support

  • Technical lead for existing and innovation to ensure suitability for international markets.
  • Support for any patent applications.
  • Provide clear direction to Procurement team around materials sourcing, specifications of ingredients and costs.
  • Give regulatory advice during product development to make sure new and updated products meet requirements in different markets.
  • Advise on cosmetic claims substantiation requirements (efficacy testing, clinical studies, consumer use tests, or scientific literature support).
  • Support marketing teams to ensure cosmetic product claims are legally compliant, not misleading, and consistent across markets.

Teamwork, Training & Improvements

  • Support business growth by identifying new opportunities, new markets and helping assess regulatory requirements.
  • Assist entire Advanced Nutrition Programme team in upskilling wider business, industry and distributors on nutrition.

Secondary Duties:

  • Be involved in and lead productivity workshops to improve efficiency and manage operating costs.
  • Make suggestions for improvement and help implement agreed actions by participation in improvement projects.
  • Maintain a safe and clean working environment in order to comply with defined company and industry standards.
  • Understand and use the company’s designated systems.
  • Take on any other responsibilities or tasks that are within the employee’s skills and abilities whenever reasonably instructed

The Candidate:

  • Masters in science graduate or equivalent with experience in Nutraceutical and Cosmetics Quality Assurance and Regulatory Affairs.
  • Extensive experience in a similar Quality Assurance related role in Nutraceutical and cosmetics and food supplement Industries.
  • Knowledge of EU, USA, Canadian, Australian and APAC quality related pharmaceutical / nutraceutical regulations.
  • Experience of conducting quality-based investigations and root cause analysis.
  • Understanding and capable of meeting the quality and regulatory requirement for annual audits to the level of FDA, NSF or other global standards.
  • Understanding and experience of Change Control.
  • Strong IT skills including MS Office and internal systems.
  • Ability to prioritise a high workload, meticulous attention to detail and extremely organised.
  • Strong communication skills to work across countries and departments.
  • Supportive team player to help upskill and mentor teams.

Regulatory Manager

Company: Piping Rock UK

Reports to: Managing Director
Location: Leicester Office
Salary: Competitive

 

Job description

Purpose

  • Support the monitoring of local Regulatory intelligence for the Consumer Health portfolio responsibilities.
  • Support the product development function with specification reviews, formula generation and advise on nutritional information to briefs/EFSA approved label claims.
  • Approval of labels for own brand and customer labels and reviews to enable commercial activation of product launches.
  • Maintaining and updating product technical files.
  • Maintain strong awareness/knowledge of current Regulatory legislation.
  • Ensures Regulatory best practice at all times and promote a constant monitoring program.
  • Assist in supporting with other product categories as required by business need (For example e.g. Cosmetics, Medical Devices, animal nutrition).
  • Provide copy and legal information for labels, websites and other platforms as required.
  • Submission of Trademarking applications and responsibility for the company’s intellectual property.
  • Maintain and adhere to the high standards we adopt for SOP’s and our BRCSG standard.
  • Review tasks with constant improvement in mind putting quality and food safety at the forefront of everything we do.
  • Advise the organisation of potential regulatory risks in normal day to day activities and recommend compliant actions.
  • Maintaining and updating product technical files.
  • Work closely with manufacturers to ensure required documentation and compliance evaluations are in place for successful product distribution and notifications.
  • Ensure formula, ingredient and label compliance as per local regulations.

 

Role requirements:

  • Pharmaceutical or scientific university degree.
  • Strong management and development skills.
  • 5+ years’ experience of working in a Regulatory position.
  • Works independently to plan, conduct, and manage regulatory and multiple projects to meet department and company objectives.
  • Project management, understanding of Regulatory environment, interaction with the Regulatory Authorities, commercial / strategic awareness, implement Regulatory strategy, managing and maintaining Marketing Authorisations.
  • Commercial Awareness.
  • Experience and knowledge of local UK Regulatory landscape a must.
  • Experience and knowledge of EU Regulatory landscape nice to have.

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