Remote Director, US Regulatory Affairs Lead Oncology

Retained Search

Shepherd Regulatory has been retained for a newly created remote US Regulatory Affairs Lead, Oncology position. This position will be accountable for developing and maintaining the US regulatory strategy documents and advising on US regulatory issues. Our client is committed to the development and commercialization of innovative oncology therapies.

Position Overview: The Regulatory Affairs Lead is responsible for proactively developing innovative and robust US Regulatory Affairs Strategies for assigned products and lifecycle assets in the oncology portfolio. In this role, you will serve as the liaison to the FDA for assigned oncology projects in clinical development. This position will lead the strategic development of documentation submitted to the FDA and lead FDA meetings and negotiations.

Key Responsibilities:

• Responsible for regulatory strategy supporting product development plans, clinical trials and new drug applications, and product life cycle management.
• Act as a strategic thinker with a “think out of the box” mindset equipped with an ability to facilitate complex decision-making and a willingness to defend difficult positions.
• Keep up with the current knowledge and understanding of complex medical and scientific subject matter and evolving US regulatory changing landscape.
• Demonstrated experience with authoring and preparing regulatory submissions, including NDA, MAA, INDs, Health Authority meeting briefing documents, and proven success in all types of formal meetings with the US FDA, including the Oncology Division.
• Prepare strategy and development of filings achieving award in expedited status including but not limited to accelerated approval, breakthrough designation, fast track, and priority review.
• Experienced in confirmatory trial in strategy development and mitigating risks/ challenges.
• Focus on clinical, and regulatory affairs filings and provide strategic and operational leadership on the project teams based on a thorough understanding of the development of drug products.

Requirements:

• B.A./B.S. or higher degree (s) in the sciences, or health-related field, minimum 8 years regulatory strategy experience.
• At least 5 years’ experience in drug development with recent 3 years in Oncology.
• Solid working knowledge of drug development process and US regulatory requirements.
• Demonstrated success in developing and implementing regulatory strategies for US INDs, BLA, and NDAs throughout all phases of drug development, primarily through late-phase challenges.
• Must have experience in authoring/ preparing regulatory submissions, including meeting documents for all types of formal meetings with the FDA, INDs, NDAs/ BLAs, and key supplements.
• Must have experience in direct interaction/negotiation experience with US FDA in formal meetings.
• Demonstrated experience successfully guiding the clinical team through a complicated and ever-changing regulatory landscape.
• Proven ability to plan, coordinate and lead activities simultaneously on multiple projects
• Excellent personal and intercultural skills paired with the ability to work cross-functionally
• Experience in electronic document management systems and e-filing to the FDA portal.

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