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Job description
Due to an increase in new business wins and to support Inceptua’s longer term strategic growth ambitions, we are seeking experienced Regulatory Affairs professionals to support and drive regulatory activities across our Early Access and Clinical Trial Supply programs.
In this role, you will provide strategic regulatory guidance, ensure compliance with global requirements, support client projects, and collaborate with cross-functional teams to deliver innovative solutions for patients and clients worldwide.
The role could be located in our office in Windsor – UK, or in our office in Stockholm, Sweden.
Responsibilities include, but are not limited to:
- Lead and implement regulatory strategies for Early Access and Clinical Trial Supply programs, ensuring compliance with global and local regulatory requirements.
- Liaise with regulatory authorities and external partners when required.
- Provide expert regulatory guidance to clients, project teams, and internal stakeholders, supporting program delivery, market access solutions, and business development activities.
- Serve as the regulatory subject matter expert, identifying appropriate regulatory pathways, interpreting country-specific requirements, and supporting successful project execution across international markets.
- Prepare, review, and maintain regulatory documentation, including submission dossiers, regulatory plans, labelling proposals, and supporting records.
- Ensure compliant and high-quality regulatory deliverables that meet applcable regulatory and client requirements.
- Support country-specific approvals and operational teams with regulatory expertise while maintaining inspection-ready documentation.
- Monitor global regulatory developments, industry trends, and country-specific legislation impacting Early Access programs. And communicate regulatory updates to relevant stakeholders.
- Support compliant safety reporting processes in line with regulatory requirements and client agreements.
Your profile
- 3-5+ years of Regulatory Affairs experience within the pharmaceutical industry, CRO environment, or related healthcare services organization, including exposure to Early Access programs.
- Degree in Life Sciences, Pharmacy, Quality Management, or a related scientific discipline.
- Strong knowledge of global regulatory requirements, including EU regulations, US CFR requirements, and GMP/GDP principles.
- Experience preparing regulatory submissions and supporting international regulatory activities.
- Excellent analytical, organizational, and problem-solving skills.
- Strong attention to detail and commitment to quality and compliance.
- Ability to manage multiple priorities in a fast-paced international environment.
- Proactive, collaborative, and solution-oriented mindset.
- Excellent written and verbal communication skills in English.
- Ability to work independently while taking ownership and accountability for deliverables.
This position is full-time. Our company is home to employees from diverse backgrounds who speak a range of languages. With teams across different locations and cultures, we value diversity and believe that inclusive collaboration makes us stronger.