Head of Staff - Pharmaceutical Operations/Product Launch

Position Overview
We're seeking a strategic and entrepreneurial Chief of Staff with deep expertise in FDA compliance and pharmaceutical operations. This role will be instrumental in driving product launches, scaling operations, and managing regulatory affairs in a fast-paced environment.

Key Responsibilities

• Lead the development and implementation of product strategies in alignment with regulatory requirements and company goals.
• Oversee compliance and quality assurance processes to ensure adherence to FDA regulations and industry standards.
• Manage FDA filings(NDA, ANDA, 505(b).
• Manage cross-functional teams to drive project execution and improve operational effectiveness across the product lifecycle.
• Develop and monitor budgets for product development projects, ensuring financial efficiency and accountability.
• Engage with stakeholders to align product strategy with market needs and organizational objectives.
• Utilize Lean Six Sigma methodologies to identify opportunities for process improvement and operational excellence.
• Foster relationships with Contract Development and Manufacturing Organizations (CDMOs) to enhance product development and supply chain management.
• Guide clinical trial operations, ensuring timely execution and compliance with regulatory requirements.
• Drive risk management strategies to identify, assess, and mitigate potential risks associated with product development and operations.
• Facilitate team development and training to enhance capabilities in strategic planning and project management.
• Collaborate with R&D, Regulatory Affairs, Marketing, Engineering, and Operations team to enhance product launches.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, or a related field; a Master's degree or MBA is preferred.
• 5+ years of experience in pharmaceutical operations or product strategy, with a proven track record in leadership roles.
• Entrepreneurial experience in Pharma/Product Launch highly desired.
• Strong knowledge of compliance, quality assurance, and regulatory affairs within the pharmaceutical industry.
• Hands-on Experience with FDA filings and international drug approvals.
• Strong leadership capabilities in scaling pharmacies, laboratories, and product lines.
• Experience in E-Commerce/Tech enabled Healthcare businesses is a plus.
• Deep understanding of pharma equipment, processes, and compliance frameworks.
• Demonstrated experience in project management, including planning, execution, and budget management.
• Proficient in stakeholder engagement and cross-functional team leadership.
• Experience in process improvement and operational excellence, with certification in Lean Six Sigma being a plus.
• Strong understanding of supply chain management and clinical trials processes.
• Excellent communication and interpersonal skills, with the ability to influence and motivate teams.

Benefits

• Highly competitive compensation package ($150-200k DOE)
• Opportunity to lead from within, rapidly scaling leader in the Pharma space
• Growth-minded company culture and highly collaborative environment, tons of growth potential
• 100% company paid Medical, dental, vision coverage, plus Short Disability Insurance and Life Insurance
• 401(k) company match
• PTO and Company Holidays
• Make a tangible impact in an exciting, fast-paced environment

For this position you must be currently authorized to work in the United States. We do not sponsor for this position.