Counsel, GxP Compliance

Role Summary

Counsel, GxP Compliance. Provide legal counsel focused on GxP and Quality processes across development, manufacture, and distribution of drugs, biologics, medical devices, supplements, and cosmetics; guidance on regulatory compliance with GxP requirements; collaboration with Quality, Regulatory, and other stakeholders; and support for regulatory communications and external engagements.

Responsibilities

• Responsible for counseling clients on a wide range of issues with focus on GxP and Quality processes for the development, manufacture, and distribution of drugs, biologics, medical devices, supplements, and cosmetics.
• Provide timely and effective counsel related to compliance with GxP regulations from various health authorities (e.g., FDA, EMA, TGA, Health Canada, WHO).
• Assist with development of corrective action plans and responses following regulatory inspections and inquiries.
• Assist in developing materials for regulatory meetings and preparing teams participating in such meetings.
• Participate in committee meetings to review internal quality metrics and participate in site or project governance committees, as needed.
• Provide guidance on product quality incidents and post-marketing reporting obligations and actions.
• Work cross functionally with Quality, Regulatory, and other stakeholders to advise on and support process and systems improvements, including development of global quality policies and training materials.
• Prepare and edit written reports and communications for internal and external use related to regulatory and GxP compliance requirements and obligations.
• Monitor the external environment and advise teams on policy and regulatory developments related to GxP and related activities.
• Manage engagements with outside counsel to ensure effective and efficient use.
• Perform related duties as assigned.

Qualifications

• Juris Doctorate is required and 7 years of experience in Pharmaceutical or biotechnology industry as inside or outside counsel. Three to five years of technical expertise in manufacturing and GxP auditing preferred. Related experience/education may also be considered.
• Seven years of Legal experience advising clients directly or under the supervision of lawyers.
• Licensed to practice law in one or more jurisdictions is required.
• Exceptional oral and written communication skills, including strong presentation capabilities.
• Strong interpersonal and conflict resolution skills.
• Ability to work in a collaborative, team-oriented environment.
• Background/education in science related discipline is preferred.
• This role may have remote flexibility.
• Proficiency in speaking, comprehending, reading and writing English is required.

Skills

• GxP regulatory knowledge (FDA, EMA, TGA, Health Canada, WHO)
• Legal counsel in pharmaceutical/biotech settings
• Regulatory inspections and response management
• Policy and regulatory monitoring
• Cross-functional collaboration
• Excellent written and oral communication

Education

• Juris Doctorate

Additional Requirements

• Remote work flexibility may be available.