Dr. Reddy's Laboratories (NYSE: RDY) is an emerging global pharmaceutical company with proven research capabilities. The company is vertically integrated with a presence across the pharmaceutical value chain. It produces finished dosage forms, active pharmaceutical ingredients and biotechnology products and markets them globally, with focus on India, US, Europe and Russia. The Company conducts research in the areas of cancer, diabetes, cardiovascular, inflammation and bacterial infection.
Post: Regulatory Compliance Manager / Senior Manager
Job Description:
Independently manage the preparation, submission, and monitoring of the progress of FDA reviews of NDA/ANDA's. This includes direct communication with the FDA by telephone or letter.
Direct communication with Dr. Reddy's functional groups (Research, Regulatory Affairs, QC/QA, Product Development, Marketing, etc.) for the coordination and preparation of data for submission to the FDA and other regulatory agencies.
Coordinate both plans of action and status reports with Manager, helping to support the development of important policy decisions. This includes routine policy decisions made independently or with the consultation of Manager and working independent in planning and execution.
Make recommendations regarding compliance of documentation, reporting the status of adverse reaction and various other regulatory requirements (format of reports, conduct investigations, etc.)
Recommendation of action made to others resulting from FDA requests for additional information, FDA citations or internal problems requiring preparation of data or responses by other departments.
Internal: Regulatory interface with Regulatory Affairs, Research, Product Managers, QC, and Product Development in regards to format of reports for submissions to FDA.
Preparation of adverse reaction reports, compliance with Good Manufacturing Practices Regulations, manage the preparation and status of pending supplemental applications, assisting in appropriate management review and approval.
Creation of Annual product reviews for QC/Operations Management
Create and maintain a document management system with appropriate distribution for regulatory documents
Manage all reporting and interaction requirements for regulated products
Manage review of internal document system for compliance to Regulatory commitments
Manage all Regulatory Federal, and State license requirements for the Shreveport site.
External: Regulatory interface with any foreign regulatory agencies, FDA, BATFE, and DEA personnel in regards to submissions and questions
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Candidate Profile:
Education Preferred: M.S. preferred but B.S. acceptable in a life science curriculum or equivalent work experience.
Experience Preferred: 5+ years in the pharmaceutical industry with at least 3+ years of experience in drug regulatory affairs for marketed drugs.
Major Skills Required:
Proficiency in pharmaceutical and relevant scientific discipline.
Knowledge of federal regulations pertaining to drugs.
Ability to read and interpret scientific reports.
Excellent organizational, verbal, and written communication and interpersonal skills.
Sound decision-making ability, as the position requires constant policy determinations and negotiations with officials and Dr. Reddy's personnel at Shreveport, Bridgewater, Charlotte, and India.
Additional Information:
Experience: Min. 5 Years
Location: Shreveport, LA
Education: BS, MS - Life Sciences
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
Job Code: 2177698
Last Date: 22nd Nov., 2011
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