Director, Regulatory Science

W2 Contract

Pay Rate: $100 - $125 per hour

Location: Redwood City, CA - Remote Role

Duties and Responsibilities:

• Deliver a sound regulatory strategy to program teams.
• Motivate, mentor, and develop direct reports.
• Ensure drug development programs are fully resourced for applicable stages of development. Anticipate upcoming work; ensure robust and effective regulatory strategy support.
• Ensure regulatory strategy takes account of competitive developments, expert feedback, and that advice is aligned with company goals and objectives.
• Ensure regulatory advice, policy, and decision-making are consistent across programs and that learnings from one program are fully considered in all other programs.
• Establish highly collaborative and effective relationships with management colleagues in Clinical Research, Clinical Operations, Regulatory Affairs, Medical Writing, Quality, and other functions to ensure cross-functional alignment and team effectiveness.

Requirements and Qualifications:

• Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs, including regulatory strategy and leadership roles.
• Demonstrated success in leading regulatory submissions globally.
• Direct experience with oncology drug development.
• Experienced in representing Regulatory on cross-functional teams and presenting to senior management. Excellent communicator.
• Excellent planning and organizational skills, and the ability to work simultaneously on multiple projects with tight timelines.

Preferred Qualifications:

• An advanced degree is desirable.
• Experience with combination studies, multiple expansion cohorts, basket or umbrella, and master protocols is highly preferred.
• Prior NDA experience is highly preferred.

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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