Senior Manager Regulatory Affairs | Abbott | Mumbai

Job Description

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 teams 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 for 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 trials, Variations & query responses
• Review & approval of Promotional Material
• Update the 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 a related subject.  A 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