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Job #02981

About our client Our client is a leading global producer of active pharmaceutical ingredients. The company has demonstrated strong growth and profitability in recent years and brings a lengthy history of innovation to each of its products. With a profit sharing program and best-in-class benefits this is a great situation for a candidate that is pursuing a challenging and visible leadership opportunity. Position Location Director of Regulatory Affairs and Compliance Connecticut Salary Highly competitive package, commensurate with experience Responsibilities 1) Lead and manage a highly active and successful international Regulatory and Compliance Group 2) Oversee global regulatory submissions such as US and European Drug Master Files (DMFs), Certificates of Suitability (COS), DMF amendments, annual reports and supplements 3) Provide regulatory guidance and technical support to the company’s final dosage customers along their path to approval 4) Prepare and manage API technical packages submitted to customers 5) Conduct routine GMP inspections 6) Prepare for and attend FDA inspections as well as customer GMP audits of the company’s international API suppliers (primarily in China) 7) Respond to any deficiencies (e.g. 483 or other deficiencies) resulting from an inspection Requirements 1) Bachelor's degree or higher in a scientific field 2) Minimum 5 years of experience in pharmaceutical regulatory affairs and compliance 3) API experience and analytical laboratory experience preferred 4) Prior managerial experience 5) Working knowledge of regulatory, GMP compliance and FDA regulations along with applicable laws 6) Ability to interact effectively with other business units including sales and R&D to coordinate as well as accomplish customer and FDA needs and expectations 7) Willingness to travel – up to 15% (international, primarily China)