Director, Regulatory Affairs

Regulatory Affairs

Reporting To: VP, Regulatory Affairs

Responsibilities

• Assist VP with responsibilities relating to FDA and other regulatory agencies worldwide
• Oversees quality audits with FDA, CPC customers and third party auditors
• Co-ordinate regulatory filings with FDA and other regulatory agencies worldwide
• Oversees Regulatory department to ensure compliance with government regulations, FDA and ICH guidance’s, drug listing program
• Review regulatory applications and submissions such as ANDAs, amendments, supplements, Annual Reports, additional documents, as needed, in accordance with FDA guidelines and to review specific changes.
• Ability to read and interpret regulatory guidelines as they apply to submission documents
• Review product dossiers and various regulatory documents
• Manage customers’ registration process
• Support various departments’ compliance and regulatory issues as necessary

Experience must include knowledge of: • cGMPs related to US FDA and EU EMEA • Quality System requirements • ICH, USP, and EP requirements • Analytical principles and manufacturing processes • Product registration requirements via NDA/ANDA pathways • Validation study designs (e.g. method, cleaning, process) • ICH CTD format

Qualifications

• Bachelor’s degree in Legal, Compliance, Business or related
• Ten years work experience in regulatory affairs or quality assurance
• Strong ability to compile, manage, and interpret data
• Knowledge of analytical principles and manufacturing processes
• Ability to compile and evaluate data from various departments
• Ability to communicate effectively, make presentations and write concise reports
• Ability to manage changing priorities
• Advance knowledge of word processing, spreadsheets, graph/charts, and databases
• Excellent technical/medical writing skills

CPC is offering a professional, stable work environment with excellent opportunity for career growth in a dynamic company, a competitive salary and a comprehensive benefits package, which includes medical, dental, life insurance, paid time-off, and 401(k) plan.

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