General Counsel, Leadership (Director Level & Up), Regulatory
Lachman Consultants, leader in providing consultation and remediation services to the worldwide pharmaceutical and related industries, is seeking Pharmaceutical or Regulatory body senior professionals and Regulatory Counsel with extensive background in food and drug law to join its Executive Management team. Candidates are sought from senior level positions from regulatory body senior roles and from law firms with a speciality in food and drug law. Candidates must have intricate knowledge of pharmaceutical regulatory processes and strategic planning and be skilled / considered an expert in:
FDA/ICH regulations and guidances
Preparation, review, and maintenance of DMFs, NDAs, ANDAs, INDs, BLAs, PMAs, 501ks and suitability petitions for various dosage forms / medical devices
Patent certification / exclusivity strategies
ADE reporting systems and practices
Due diligence audits for mergers and acquisitions
Marketing exclusivity legal challenges
Preparation for and presentation at FDA meetings
Pre- and post-marketing related document preparation
Regulatory strategies and assessments
Clinical trial documentation
Labeling and marketing materials
Bachelor’s Degree in life sciences or related field; JD a plus
10+ years Regulatory leadership experience in pharmaceutical industry, Regulatory Agency or counsel with food and drug law speciality
Ability to skillfully and appropriately manage, develop, and mentor personnel
Ability to work effectively under strict time lines
Strong written and oral communication skills with the ability to interact well at all levels
Ability to apply good judgment / recognize and differentiate importance of issues and prioritize accordingly
The person in this position must travel on occassion as needed.
Telecommuting is allowed.
Additional Salary Information: Salary is commensurate with experience
For nearly four decades, Lachman Consultants has been the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries. With its strong and extensive cadre of consultant specialists and an unparalleled management team, its Compliance, Science & Technology, and Regulato...ry Practices provide the most expert counsel and array of services available. Lachman Consultants is proud of its tradition of supporting industry efforts to develop and ensure safe, effective and high-quality medical products. It remains committed to helping the industry anticipate and address its challenges through the development and implementation of practical, sustainable and cost-effective solutions based on the integration of scientific principles, evolving regulatory expectations, and technology.