Maclivaro Limited
Director of Regulatory Affairs
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Regulatory Affairs Director (Contract)
Remote – England, UK | 2–3 Days per Week | Contract
About the Company
We are an innovative health technology company developing next-generation microneedle drug delivery platforms designed to transform how medicines and vaccines are administered. Our proprietary technology combines pharmaceutical science with advanced medical device engineering to create minimally invasive, thermally stable delivery systems that have the potential to improve patient access, simplify treatment pathways and address global healthcare inequalities.
Working at the intersection of pharmaceuticals, biologics and medical devices, we are progressing novel combination products through development towards clinical and commercialisation. We are seeking an experienced Regulatory Affairs Director on a part-time contract basis to provide strategic regulatory leadership during an exciting stage of product development.
The Opportunity
This is a senior contract opportunity for an experienced Regulatory Affairs professional with extensive expertise in pharmaceutical combination products, drug-device products and MHRA submissions.
Working remotely for approximately 2–3 days per week, you will provide strategic regulatory leadership, guiding the organisation's regulatory roadmap and ensuring products progress efficiently through development and regulatory approval.
You will work closely with the executive leadership team, providing expert advice on regulatory strategy, submissions and compliance while collaborating with R&D, Quality, Clinical and Manufacturing teams.
This role is ideally suited to an experienced regulatory consultant or interim leader who enjoys working with innovative early-stage healthcare technologies and can make an immediate impact.
Key Responsibilities
- Lead the regulatory strategy for innovative pharmaceutical combination products.
- Provide expert guidance on UK regulatory requirements and MHRA engagement.
- Develop regulatory pathways for combination products from development through to commercialisation.
- Prepare, review and oversee MHRA submissions, including Clinical Trial Applications (CTA), Marketing Authorisation Applications (MAA), Scientific Advice requests and lifecycle submissions.
- Advise on regulatory strategy for UK, EU and international markets, including FDA considerations where applicable.
- Act as the organisation's subject matter expert for pharmaceutical and medical device regulatory requirements.
- Support product classification, regulatory pathway decisions and development planning.
- Work collaboratively with Quality Assurance, Clinical, Manufacturing and Product Development teams to ensure regulatory compliance.
- Review technical documentation, risk management files and supporting regulatory documentation.
- Lead interactions with regulatory authorities and external regulatory consultants.
- Monitor changes in global regulatory legislation and assess business impact.
- Provide regulatory input to executive leadership, investors and strategic partners where required.
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Skills & Experience - Essential
- Degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Biomedical Engineering or a related scientific discipline.
- Significant Regulatory Affairs experience within pharmaceutical, biotechnology or medical device environments.
- Extensive experience with pharmaceutical combination products (drug-device combination products).
- Demonstrable experience leading MHRA submissions and regulatory interactions.
- Strong understanding of UK medicines legislation and regulatory requirements.
- Experience preparing CTAs, MAAs and lifecycle regulatory submissions.
- Knowledge of ICH Guidelines, GMP and GCP.
- Experience supporting innovative medicines, biologics or advanced drug delivery technologies.
- Ability to work independently while providing strategic advice to senior stakeholders.
- Excellent communication and stakeholder management skills.
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Desirable
- Experience with FDA Combination Product regulations.
- Knowledge of EMA regulatory procedures.
- Experience with CE Marking and UKCA requirements.
- Understanding of ISO 13485 and ISO 14971.
- Experience within start-up, biotech or scale-up environments.
- Experience with transdermal drug delivery, vaccine technologies or microneedle platforms.
- RAC (Regulatory Affairs Certification) or equivalent.
Technical Skills
- Pharmaceutical Combination Products
- Drug-Device Combination Product Regulations
- MHRA Regulatory Framework
- EMA Regulatory Procedures
- FDA Combination Product Guidance
- Clinical Trial Applications (CTA)
- Marketing Authorisation Applications (MAA)
- eCTD Submissions
- Regulatory Strategy Development
- Regulatory Intelligence
- ICH Guidelines
- Good Manufacturing Practice (GMP)
- Good Clinical Practice (GCP)
- ISO 13485
- ISO 14971 Risk Management
- Design Controls
- Technical Documentation
- Clinical Evaluation
- Regulatory Information Management Systems (RIMS)
- Electronic Document Management Systems (e.g. Veeva Vault, MasterControl)
- Microsoft Office Suite
What We're Looking For
We're looking for a highly experienced regulatory professional who can quickly understand complex technologies, provide practical regulatory guidance and help shape the company's route to market. You'll be comfortable working autonomously, influencing senior stakeholders and balancing strategic thinking with hands-on regulatory delivery.
Contract Details
- Contract: Independent Contractor / Consultant
- Commitment: Approximately 2–3 days per week
- Location: Fully Remote (England, UK)
- Duration: Initial contract with the potential for extension
- Start: ASAP
This is an excellent opportunity to support the development of an innovative drug delivery platform with the potential to transform the administration of medicines and vaccines while providing strategic regulatory leadership on a flexible, part-time basis.
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