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Regulatory Affairs Manager, Early Access

On behalf of our client Inceptua, offering strategic and tailored solutions for clinical trial supply and early access to medicines worldwide, we are looking for a Regulatory Affairs Manager, Early Access.

WHAT INCEPTUA CAN OFFER

Joining Inceptua means becoming part of a fast-growing global pharmaceutical services company dedicated to improving patient access to medicines worldwide. Regulatory Affairs plays a strategically important and commercially central role within the organization. The function is critical to successful program delivery and works closely with Supply Chain, Programme Management, Operations, Quality, and Commercial teams. You will play a key role in client relationships and commercial activities.

The company values initiative, accountability, collaboration, and a strong work ethic, while offering opportunities for professional development within a growing, entrepreneurial Life Science organization.

THE COMPANY

For more than 25 years, Inceptua has partnered with pharmaceutical and biotechnology companies to help improve patient access to medicines worldwide. Operating across Europe, North America and Asia, the company provides specialized services throughout the product lifecycle, including Clinical Trial Supply, Early Access Programs, Global Distribution and Regulatory Support.

KEY RESPONSIBILITIES

Regulatory Strategy & Program Support

• Ensure compliance with applicable ethical standards, regulatory requirements, company policies, and client agreements.
• Provide regulatory expertise and guidance to Early Access (and Clinical Trial Supply) business units.
• Lead regulatory support and oversight for assigned programs and projects.
• Develop and maintain regulatory strategies and plans aligned with program objectives and market-specific requirements for the Early Access Business Unit.
• Research and interpret country-specific requirements to identify appropriate regulatory pathways.
• Advise clients on regulatory strategies and solutions for individual programs.
• Contribute to RFQs, including regulatory assessments and market-specific recommendations.
• Participate in bid defense meetings, presenting regulatory recommendations and addressing client questions.
• Act as a regulatory subject matter expert for internal and external stakeholders.

Documentation & Regulatory Submissions

Prepare, review, and maintain client-specific regulatory documentation, including, such as Regulatory plans, Submission packages and Program-supporting documentation.

• Ensure regulatory documentation is accurate, high-quality, and compliant.
• Support country-specific approval processes with regulatory information and guidance for operational teams.
• Support operational teams with regulatory documentation and compliance requirements for individual orders.

Regulatory Intelligence & Compliance

• Monitor global regulatory developments and identify new or revised country-specific legislation, guidance, and requirements.
• Analyze and summarize regulatory updates and maintain information in regulatory intelligence systems.
• Research and document country-specific labelling requirements, ensuring accessibility through regulatory databases and tools.
• Maintain regulatory archives, intelligence repositories, and databases to ensure accurate, current information is available across the organization.
• Monitor global regulatory developments, industry trends, and best practices, including new or revised country-specific legislation, guidance, and requirements.

Safety & Pharmacovigilance Support

• Support the maintenance of compliant safety reporting processes in line with client agreements and applicable regulations.
• Monitor safety reporting metrics and escalate risks, deviations, or compliance concerns as appropriate.
• Contribute to business continuity planning for safety operations and support contingency plan implementation when required.

Quality & Process Improvement

• Assist in the development, implementation, maintenance, and continuous improvement of internal regulatory and safety procedures.
• Ensure regulatory processes align with applicable regulations, industry best practices, and quality standards.
• Maintain accurate records and documentation for regulatory inspections, audits, and internal compliance reviews.
• Support corrective and preventive actions following audits, inspections, or process reviews.

You will be reporting to the Senior Director, Global Regulatory Affairs, based in the UK.

COMPETENCE REQUIREMENTS & ABILITIES

• Relevant professional experience within Regulatory Affairs, with knowledge of regulatory requirements and compliance principles.
• Experience supporting Early Access programmes is required.
• Ability to interpret complex regulatory requirements and translate them into practical recommendations.
• Strong analytical, research, organizational, and documentation skills.
• Excellent communication and presentation skills, with the ability to explain complex regulatory matters clearly and confidently to clients.
• Strong stakeholder management and cross-functional collaboration skills.
• Effective management of multiple projects and priorities in a fast-paced environment.
• High attention to detail with a commitment to quality and compliance.
• Capacity to work independently, take ownership of responsibilities, and demonstrate accountability and a strong work ethic.
• Fluency in written and spoken English.

For more information, please contact us at Brice Group;

Adina Lekberg Salamon adina.lekbergsalamon@brice.se

Ola Gustavsson, ola.gustavsson@brice.se