Manager, Regulatory Affairs Strategy - Clinical Development

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Requirements:

• Bachelor's degree in a scientific discipline; advanced degree preferred.
• Minimum of 8 years of regulatory experience in the pharmaceutical or biotechnology industry.
• Extensive knowledge of global regulatory submission and approval processes.
• Proven ability to manage regulatory submissions.
• Strong communication and leadership skills.

Responsibilities:

• Develop and implement global regulatory submission strategies for clinical trials.
• Lead regulatory activities and address regulatory questions and concerns.
• Participate in proposal preparation and bid defenses.
• Collaborate with global teams to support regulatory submission management.
• Provide guidance on regulatory requirements and represent regulatory in strategy discussions.
• Manage interactions with regulatory authorities and provide strategic input into submissions.