Regulatory Strategy Manager in Pharmaceuticals

Enhance clinical trial outcomes as a Regulatory Strategy Manager. Provide structured guidance and support for regulatory submissions and compliance with applicable standards.

You will play a vital role in maintaining compliance throughout the life cycle of clinical research, coordinating applications and ensuring strategic regulatory input is provided. This position also requires leadership in managing regulatory affairs specialists and fostering collaboration within project teams.

Key Responsibilities:

• Coordinate and review regulatory submissions for multiple authorities
• Develop compliance strategies and project plans
• Serve as a regulatory expert in project meetings
• Oversee training on regulatory standards and protocols
• Maintain regulatory intelligence and project trackers

Requirements

• Bachelor's degree in a scientific discipline
• Minimum of 5 years in regulatory affairs
• Knowledge of drug development processes
• Expertise in EU or US regulatory requirements
• Strong problem-solving and communication skills

Drive success in clinical trials by leveraging extensive knowledge of regulatory practices and fostering a culture of compliance within teams.

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