Abbott Pharma & Chemistry Job – Regulatory Affairs
Abbott Regulatory Manager Recruitment 2020 Abbott Pharma Job Opening. Pharma Job Opening. Abbott invites undergraduate Pharma candidates for the post of Specialist. Check out all the details on Rasayanika.com
Job Title: Sr MANAGER– REGULATORY AFFAIRS
Location: REGULATORY AFFAIRS INDIA – MUMBAI
Eligibility:
Bachelor’s Degree / Diploma in pharmacy, chemistry, pharmacology or a related subject. Diploma in Regulatory Affairs is preferred.
MINIMUM EXPERIENCE/TRAINING REQUIRED:
- 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
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
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
PRIMARY JOB FUNCTION:
- Â 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 a cross-functional team on shared goals
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