REMOTE Manager, Regulatory Affairs Strategy - Clinical Development

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Requirements:

• Bachelor’s degree in a scientific discipline (e.g., Life Sciences, Pharmacy, Biotechnology) or equivalent; advanced degree preferred.
• Minimum of 8 years of regulatory experience in the pharmaceutical or biotechnology industry, with a focus on clinical development.
• Extensive knowledge of global regulatory submission and approval processes.
• Proven ability to manage regulatory submissions.
• Strong communication and leadership skills.

Responsibilities:

• Responsible for developing and implementing global regulatory submission strategies for global clinical trials.
• Lead regulatory activities and address regulatory questions and concerns.
• Participate in proposal preparation and bid defenses, collaborating with global teams.
• Provide regulatory guidance for drug and medical device clinical trials.
• Manage regulatory submission activities, including planning, authoring, and reviewing submissions.
• Ensure regulatory contributions achieve strategy objectives, standards, and facilitate EU submission activities.