Position Summary

The VP, Regulatory Affairs is responsible for ensuring that all regulatory strategy and filings are high quality, efficient, thorough and complete. This includes complying with regulatory requirements: filings and interaction with the FDA and other health authorities.

Position Responsibilities:

  • Regulatory Filings and Approvals: Complete regulatory documents (in house and with vendors) and serve as the in-house regulatory expert to internal and external parties. Work with project teams and project manager to ensure this is delivered.
  • Regulatory Agency Interface: Serve as the interface between the regulatory agencies and our company, ensuring good and early communication. Ensure input from regulatory agencies is interpreted correctly by project teams, and action taken to prevent misunderstandings that could delay programs, put patient safety at risk or interrupt planned clinical development programs. Maintain up to date knowledge of regulatory affairs.
  • Advice to Management: Ensure that the Management team understands program strategy, feedback from regulatory agencies on clinical plans, clearly understanding associated risks with the programs.
  • Partner Collaborations: Manage the relationship with our external partners, ensuring that the interests of the Company are protected.
  • Diligence on New Assets: Conduct gap analysis, assess regulatory risk, and advise on clinical development of assets under consideration for licensing.

Qualifications:

  • MS or PhD in Chemistry, pharmacology, or closely related field.
  • Biotech industry experience in Regulatory Affairs and/or CMC Regulatory in dermatology, rheumatology, metabolic, CNS or related disease areas. Experience with both small molecules and biologics is a plus.
  • Strong track record in Regulatory Affairs and CMC Regulatory, including hands-on experience managing first in human trials.
  • Excellent communication skills: including verbal, written, listening, and conveying messages.
  • Proven ability to work collaboratively internally and externally
  • Results oriented and self-assured.

The range for this full-time position is $330,000 - 350,000, plus a target bonus, equity compensation and benefits including medical, dental, vision, and 401k. Our salary ranges are determined by role, level and location. The range displayed on our postings reflects the minimum and maximum for new hire salaries. Within the range, individual pay is determined by interview performance, job-related skills, experience and relevant education and training. Please note the range reflects base salary and does not include target bonus, equity or benefits.

 

We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

 

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