Manager, Regulatory Affairs

About the role

Worldwide Clinical Trials seeks a Manager, Regulatory Affairs to drive regulatory strategy and project representation across the drug development cycle. This role involves managing submissions for EMEA, Asia Pacific, and Latin America, ensuring compliance with ICH GCP, and mentoring junior staff. The position is fully remote based in India.

What you’ll do

• Provide expert regulatory advice and contribute to regulatory project work
• Ensure accurate compilation, management, and tracking of submissions
• Coordinate and manage regulatory and ethics committee submissions across EMEA, Asia Pacific, and Latin America
• Participate in business development activities including proposal preparation and bid defense meetings
• Review documentation such as labels and patient information sheets for compliance with ICH GCP
• Maintain regulatory intelligence database and stay abreast of changing legislative requirements
• Provide training, coaching, and mentoring to junior members of staff
• Deputize for the Regulatory Affairs Director as required

What you’ll bring

• Bachelor's Degree in Chemistry, Life Sciences, Nursing, or equivalent experience
• Previous experience within the pharmaceutical or CRO industry

Skills

Education

Bachelor's Degree in Chemistry or Life Sciences, Nursing or equivalent experience