Regulatory Affairs Manager, Early Access Programs

Brice Group; Stockholms län; On-site; SEK 900,000 - 1,200,000; Full time

Job summary

Inceptua, a global pharmaceutical services company, is seeking a Regulatory Affairs Manager for Early Access to join the team. You will lead regulatory strategy, support Early Access and Clinical Trial Supply programs, and liaise with clients and cross-functional teams.

Reporting to the Senior Director, Global Regulatory Affairs (UK), you will monitor regulatory developments, prepare documentation, and advise on strategic pathways across multiple markets.

Qualifications

• Relevant professional experience within Regulatory Affairs.
• Experience supporting Early Access programmes is required.
• Ability to interpret regulatory requirements and translate them into practical recommendations.
• Fluency in written and spoken English.

Responsibilities

• Regulatory Strategy: develop plans aligned with program objectives and market requirements.
• Lead regulatory support for Early Access and related programs.
• Guide regulatory submissions and maintain high-quality documentation.
• Advise clients on country-specific regulatory strategies and pathways.
• Monitor global regulatory developments and disseminate updates to teams.
• Collaborate with Quality, Supply Chain, and Commercial functions.

Skills

Regulatory Affairs

Early Access

Stakeholder Management

Regulatory Strategy

Documentation & Submissions

Compliance & Quality

Job description

Inceptua, a global pharmaceutical services company, is seeking a Regulatory Affairs Manager for Early Access to join the team. You will lead regulatory strategy, support Early Access and Clinical Trial Supply programs, and liaise with clients and cross-functional teams.

Reporting to the Senior Director, Global Regulatory Affairs (UK), you will monitor regulatory developments, prepare documentation, and advise on strategic pathways across multiple markets.