Senior Manager Regulatory Affairs Job in Abbott Laboratories

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:

Bachelors 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