Job as Executive Regulatory Affairs in Baxter India

Baxter International Inc. is a global, diversified healthcare company that develops, manufactures and markets products to treat hemophilia, kidney disease, immune disorders and other chronic and acute medical conditions. These products are used by hospitals, kidney dialysis centers, nursing homes, rehabilitation centers, doctors’ offices, clinical and medical research laboratories, and by patients at home under physician supervision.

Post: Executive Regulatory Affairs

Job Description:
* To obtain required Drug Manufacturing Licenses and Permissions from Drugs Regulatory Departments of State Drugs Controller’s and Central Drugs Control Offices for all the in-house plants.
• To support to obtain the additional products permissions, Certificate of Pharmaceutical products (COPP), WHO GMP Certificates, GMP Certificates as per Schedule M requirements from State and Central drugs control office for all plants.
• To obtain documents and Certificates required for Govt. tender purposes, viz. manufacturing and Marketing Certificates, Non-Conviction Certificate, Performance Certificate etc. for all plants. Co-ordination with Marketing/Sales team for obtaining required documents to support for participation in tenders.
• To coordinate with State Drugs Control officers and Central Drugs control officers for plant inspection purposes.
• To ensure timely renewal of the various plant manufacturing Licenses, WHO COPP renewal, Whole Sale Licenses renewals etc.
• To keep follow-ups for getting timely permissions of the products from State and Central Drug Control Offices.
• Preparation and submission of various drug regulatory applications of the plant
• Maintenance of License tracker for all the plants.

*Manufacturing, Validation & Documentation Knowledge in Parenterals products (Large Volume and Small volume Parenterals).

*To ensure production target achievement as per the production plan/ Purchase Order received from Supply chain at Contract Mfg. Site & its availability for dispatch to concern CFA as per the schedule.

Candidate Profle:
Science- Post Graduate

Additional Information:
Location: Haryana
Education: PG
Industry Type: Pharma/Biotech/Clinical Research
End Date: 10th Jan, 2015