Director, Regulatory Affairs, Sun Pharmaceuticals Industries, Inc., Billerica, MA. Manage all regulatory aspects of pharmaceutical programs in various stages of development. Develop, implement, and adjust regulatory strategies during development phases of assigned projects. Recommend regulatory strategy in accordance with current regulations and guidance. Assist in regulatory authority inspections and related responses. Direct and oversee the Drug Safety Function to ensure that all complaints, adverse events and reportable events are processed in compliance with applicable regulations. Maintain department databases and perform electronic publishing of submissions. Manage life-cycle for product registrations, domestic and international. Oversee regulatory reporting requirements for product registrations. Ensure rapid and effective development and review of regulatory documents to be submitted to the FDA and international regulatory agencies. Coordinate with preclinical, clinical, medical affairs manufacturing and quality systems groups to ensure regulatory submissions are reviewed and approved to meet project target dates. Update licensing and collect information on registration instructions and regulations both domestic and international. Ensure department representation on label review and complaint committees. Coordinate the department’s contract manufacturing efforts. Provide continuing regulatory education and dissemination of regulatory information to the product development, marketing, and clinical groups.
40 hrs/week, Mon-Fri, 8:30 a.m. - 5:30 p.m.
Bachelor’s degree or foreign equivalent degree in Life Sciences, Chemistry, Pharmaceutical Science, or a related field and eight (8) years of post-bachelor, progressive, related work experience.
Must have five (5) years of experience with/in:
Preparing regulatory submissions for development products;
Establishing regulatory interactions;
Generating submissions to regulatory authorities;
INDs (Investigational New Drug Submissions), NDAs (New Drug Applications), eCTD (electronic common technical document), A/NDA (abbreviated new drug application), and CMC (Chemistry, Manufacturing and Control) submissions;
Post approval drug products;
Review of regulatory documents to be submitted to the FDA and international regulatory agencies;
Pharmacovigilance (AE) reporting/Drug Product Quality Complaints; and
Conduction Drug Product Risk assessment and mitigation.
To apply, mail resume to: HR Supervisor, 2 Independence Way, Princeton, NJ 08540. (reference: MA0002).