Regulatory Consultant - Snr Manager

Associate Director Regulatory Affairs Contract – UK and EU

Proclinical is seeking a Senior Manager, Regulatory Consultant. This role will collaborate with global regulatory leaders and cross-functional teams to develop and implement regulatory strategies. The successful candidate will be responsible for planning and coordinating regulatory submissions to support product development, clinical trials, and product registration. This position involves active participation in multidisciplinary teams and requires staying informed on global regulatory requirements.

Responsibilities:

• Collaborate with global regulatory leaders to define and execute regulatory strategies.
• Compile and submit regulatory documents, including Clinical Trial Applications, Marketing Applications, and more.
• Develop detailed regulatory project plans and manage activities for specific products or projects.
• Provide strategic regulatory advice to project teams.
• Coordinate responses to regulatory authorities’ inquiries, ensuring timely submissions.
• Serve as a liaison within internal departments and with external partners.
• Maintain regulatory files according to internal standards.
• Review and recommend changes to technical regulatory documentation and processes.

Key Skills and Requirements:

• Bachelor’s degree required.
• Strong communication skills, both written and verbal, with the ability to negotiate and influence.
• Solid understanding of regulations and experience interpreting guidelines.
• Strategic thinking with the ability to identify issues and develop mitigation strategies.
• Experience with regulatory filings, including electronic submissions.
• Excellent organizational and project management skills.
• Ability to work effectively in a team environment and collaborate with various departments and external partners.
• Proficiency in technical systems, including word processing and databases.
• Additional professional qualifications, such as RAC certification, are beneficial.

Seniority level: Mid-Senior level

Employment type: Full-time

Job function: Science

Industries: Professional Services

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