Consulting Position – Long Term 40hrs Week – Remote

The Global Regulatory Lead Consultant is responsible for developing and directing the global regulatory strategy, objectives, policies, and programs for developing and marketing drug and/or biological products. The GRL will be responsible for global registration and life cycle support and includes the leadership of regulatory strategy for multiple projects that extend globally (United States, EU, ROW, etc.).

Responsibilities:

• Leads the development of strategic plans and tactical implementation, leading to the creation and submission of regulatory
• documents, e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs, and other relevant regulatory filings.
• Direct point of contact with health authorities, leads and manages FDA/health authority interactions/meetings. Oversees direct
• reports as needed.
• Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
• Lead regulatory reviewer in due diligence for licensing opportunities.
• Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product
• specific value evidence topics, as applicable.
• Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development
• plan(s) and adopt regulatory strategies in a timely manner.

Requirements:

• BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science or healthcare preferred or equivalent relevant experience.
• 8+ years of Regulatory experience, including equivalent experience in the biopharmaceutical industry.
• 2-5 years of management experience preferred.
• Regulatory experience should be broad (across the life cycle of pharmaceutical products and across main regions such as the US, EU, Japan, and Canada) to ensure appropriate leadership and mentoring for regulatory staff preferred experience in reviewing, authoring, or managing components of regulatory submissions.
• Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW, and post-marketing a plus.
• Understand and interpret complex scientific issues across multiple projects related to regulatory requirements and strategy.
• Strong oral and written communication, managing and adhering to timelines, negotiation skills, integrity, and adaptability.
• Demonstrates acceptable skills with increasing independence in regulatory strategy, such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
• Must work well with others and within global teams.

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