Abbott Hiring SENIOR MANAGER – REGULATORY AFFAIRS Bachelor’s Degree / Diploma in Pharmacy, biology, chemistry, Apply Now
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 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 licences, 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
MINIMUM EDUCATION:
Bachelor’s Degree / Diploma in pharmacy, biology, chemistry, pharmacology or related subject. Diploma in Regulatory Affairs is preferred.
MINIMUM EXPERIENCE/TRAINING REQUIRED:
Atleast 5-7 years 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
TO APPLY CLICK HERE
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