VP, Regulatory Affairs

Implaion Recruiting; Austin (TX); Remote; USD 150,000 - 200,000; Full time

Job summary

A leading company is seeking a Vice President of Regulatory Affairs to oversee global regulatory strategies and submissions. This hands-on role requires extensive experience in biopharma regulatory affairs, particularly with NDA submissions. The ideal candidate thrives in an entrepreneurial environment and has a proven track record of success in navigating regulatory processes.

Qualifications

• 12+ years of biopharma Regulatory Affairs experience.
• Track record of successful NDA submissions and approvals.

Responsibilities

• Oversee global regulatory strategy and submissions.
• Lead a team for regulatory strategy and approvals.
• Act as regulatory lead for company's first NDA.

Skills

Regulatory Affairs

Collaboration

Communication

Problem-Solving

Decision-Making

Education

PharmD

PhD

MD

Job description

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Overview

This is a hands-on role that requires a strong working knowledge of regulatory procedures and a proven track record leading successful NDA submissions . Candidates must be able to thrive in a high energy, small-company, entrepreneurial environment, and be comfortable developing and implementing innovative regulatory approaches.

Responsibilities

• Oversee global regulatory strategy and regulatory submissions (e.g., INDs, CTAs, NDAs, MAAs, orphan designation applications, meeting requests, and briefing documents) in support of product development across all indications
• Lead a team responsible for scientific and tactical regulatory strategy, submissions, and approvals throughout drug development
• Act as regulatory lead for preparation, submission and approval of company's first NDA
• Provide hands-on leadership of cross-functional teams (non-clinical, clinical, CMC, biostatistics) to drive preparation, review, submission and approval of regulatory filings
• Work with a cross-functional team on labelling, risk management, pharmacovigilance and post-marketing requirements
• Identify opportunities to utilize accelerated development approaches and novel endpoints to speed up development timelines; work with regulatory agencies to gain buy-in on these approaches
• Draft, review, and submit high-quality documentation for INDs, CTAs, NDAs, MAAs, and related filings to regulatory agencies, consistent with corporate goals, including original applications and product maintenance such as amendments and annual reports
• Track regulatory commitments and deliverables while coordinating with internal and external staff to ensure timely submissions
• Interact with consultants and manage external regulatory writing support, as necessary
• Ensure regulatory requirements and strategy are understood by project teams
• Serve as FDA and EMA liaison and provide leadership and support for regulatory agency meetings and teleconferences for assigned programs
• Maintain up-to-date knowledge on international and domestic regulatory requirements

Qualifications

• 12+ years of biopharma Regulatory Affairs experience, including extensive experience with the preparation and submission of INDs and NDAs/BLAs
• PharmD, PhD or MD preferred
• Track record of successful NDA submissions and approvals for novel therapies (rare disease strongly preferred)
• Strong working knowledge of global pharmacovigilance principles and requirements
• Experience successfully navigating Advisory Committee process strongly preferred
• Must have small company experience and thrive in an innovative, agile, and entrepreneurial environment, with ability to effectively collaborate and perform well under pressure
• Experience with commercial Regulatory Affairs
• Deep knowledge of GxP regulations and ICH and FDA guidance and regulations.
• Experience with small molecule development programs, particularly late stage/commercial
• Experience with expedited pathways
• Therapeutic area experience in immunology and autoimmune diseases preferred
• Experience with EU Clinical Trial Regulation and Clinical Trial Information System
• Ability to quickly assimilate technical and scientific information and consistently produce thorough and accurate work
• Desire be part of a regulatory organization that generates strategic value through creative approaches
• Able to balance strategic initiatives with hands-on work of drafting submissions, correspondence, and internal policies/procedures, with a high sense of urgency and drive for results
• Demonstrated communication, problem-solving, and decision-making skills
• Natural collaborator who enjoys working on a cross-functional team

Seniority level

• Seniority level

  Executive

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

• Industries

  Executive Search Services

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