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The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.
We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
Position: Senior Manager – Regulatory Affairs
Location: Mumbai, Maharashtra, India
Primary Job Function:
- To ensure compliance with all applicable National Regulations, Guidelines, Codes and with
- Abbott policies related to Pharmaceutical, Biologicals, Ayurvedic, Cosmetics, OTC, FSSAI products and Devices
- Active participation within the cross-functional team on shared goals
Core Job Responsibilities:
- To ensure timely submissions to Regulatory Authorities and follow up for obtaining approvals
- To build systems and processes as per the changing regulatory environment and support business needs
- To ensure local processes and SOPs are adhered to
- Align complete regulatory data packages as per local regulatory requirements
- Prepares and attends agency meetings
- Attends project teams representing EPD RA India as appropriate
- Monitors actual vs planned activities and timelines
- Responsible for existing products with respect to maintenance of licenses, prescribing information, promotional materials, etc.
- Active Participation and inputs for Regulatory Affairs Council
- Regulatory support to all FSSAI products & devices
Position Accountability / Scope:
- Registration of New Products, Subsequent New Drugs, etc, including inputs and participation in Subject Expert Committee meetings and discussions with regulatory authorities
- Registration and renewal of site/product registration and Import Licenses
- Clinical Trial applications (local & global)
- Test Import License Applications for clinical trial, Variations & query responses
- Review & approval of Promotional Material
- Update global database for product registration & variation details
- Provide inputs for I&D and NPI projects
- Preparation and updation of prescribing information
Qualification: B.Pharma/D.Pharma, biology, chemistry, pharmacology or a related subject. A diploma in Regulatory Affairs is preferred.
- At least 5-7 years of work experience, preferably in the pharmaceutical industry such as Regulatory, R&D, Quality, Medical
- Preferred experience in Global Regulatory filings, submission of registration dossiers, and post-approval variations
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