Global Regulatory Affairs Consultant

Join to apply for the Global Regulatory Affairs Consultant role at Real

Join to apply for the Global Regulatory Affairs Consultant role at Real

This range is provided by Real. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Our client, a leader in the industry, is looking for a Global Regulatory Affairs Consultant to join their team on a contract basis. This role is integral to supporting regulatory initiatives, new registrations outside of the EEA, and regulatory lifecycle management. If you have a passion for navigating the complex world of regulatory compliance, this opportunity is for you.

Key Responsibilities

• Compile and submit regulatory documents according to requirements and timelines.
• Provide expert regulatory advice to project teams and ensure timely responses to regulatory authority inquiries.
• Maintain regulatory documentation in compliance with CTD and EU regulation standards.
• Drive lifecycle management plans, including variation submissions and supporting device registrations.
• Represent Regulatory Affairs in cross-functional project teams.
• CTD and CMC Expertise: Proven ability to work with Common Technical Documents and Chemistry, Manufacturing, and Controls data.
• EU Regulation Knowledge: Strong understanding of MRP/DCP procedures and international regulation frameworks.
• Scientific Knowledge: Comprehensive knowledge of pharmaceutical sciences.
• Communication: Excellent verbal and written communication skills in English.
• Negotiation: Capable of managing regulatory discussions effectively.
• Technical Proficiency: Skilled in using word processing tools, spreadsheets, databases, and conducting online research.
• Project Management: Ability to manage multiple projects with strict deadlines.
• Compliance Awareness: Detect compliance risks and take appropriate actions swiftly.

Qualifications

• Bachelor's degree in pharmacy or related scientific discipline.
• 3-5 years of regulatory experience within a pharmaceutical company, CRO, or similar organization (higher degrees such as a PhD are advantageous).

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Temporary

Job function

• Job function

  Other

• Industries

  Pharmaceutical Manufacturing

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