Freelance Legal Consultant

Flexing It is a freelance consulting marketplace that connects freelancers and independent consultants with organisations seeking independent talent.

Our client, a Multinational professional services network is looking to engage with a Consultant who can deliver the following key responsibilities:

• Develop and advise on global regulatory strategies for pharmaceutical products.
• Provide guidance on regulatory requirements across multiple countries and regions.
• Review and interpret FDA, EMA, and other international regulatory guidelines.
• Support global product registrations, submissions, approvals, and lifecycle management.
• Advise on regulatory pathways for new products, variations, renewals, and post-approval changes.
• Ensure compliance with global regulatory standards and changing regulations.
• Identify regulatory risks and recommend mitigation strategies.
• Collaborate with cross-functional teams on regulatory requirements and documentation.
• Provide regulatory expertise for market entry and expansion into new geographies.
• Support senior stakeholders with regulatory compliance and strategic decision-making.

Skills Required

• 20–25 years of Regulatory Affairs experience in the pharmaceutical industry.
• Strong expertise in global regulatory frameworks (FDA, EMA, MHRA, Health Canada, PMDA, etc.).
• Experience managing regulatory activities across multiple countries.
• In-depth knowledge of pharmaceutical registration and submission processes.
• Strong understanding of global regulatory compliance and lifecycle management.
• Expertise in interpreting evolving regulatory guidelines and requirements.
• Experience in regulatory strategy development and risk assessment.
• Excellent stakeholder management and cross-functional collaboration skills.
• Strong analytical, problem-solving, and communication abilities.