Associate Director, Regulatory CMC

The Associate Director, Regulatory CMC will assist in the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategy and manage preparation of dossiers in eCTD format for investigational and marketed products. The position requires expertise in Health Authority CMC guidance documents and requirements, good leadership skills, and ability to manage work and staff with firm deadlines.

Requirements

• Bachelor’s Degree in life sciences or technical discipline with 10+ years of relevant progressive experience
• Master’s Degree in life sciences or technical discipline with 8+ years of relevant progressive experience
• Doctorate degree in life sciences or technical discipline with 6+ years of relevant progressive experience
• Experience in the management and preparation of the submission of CMC modules in eCTD format
• Experience with organizing responses to Health Authority requests
• Experience with regulatory submissions outside of the US preferred
• Experience managing staff preferred

Benefits

• Medical, Dental and Vision Plan Options
• Health and Financial Wellness Programs
• Employer Assistance Program (EAP)
• Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
• Healthcare and Dependent Care Flexible Spending Accounts
• 401(k) Retirement Plan with Company Match
• 529 Education Savings Program
• Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
• Paid Time Off (PTO)