Dear All now get GMP News, FDA, WHO, EU, TGA, CDSCO guidelines...and GMP Violations news/warning letters.. GMPVIOLATIONS

Tuesday, May 4, 2010

Sr. Executive / Asst. Manager Regulatory Affairs

Looking for Sr. Executive / Asst. Manager Regulatory Affairs candidates for API (Bulk drug)


3 - 8 Years
Rupees 3,25,000 - 6,00,000
Best in Industry......
UG - Any Graduate - Any Specialization,Graduation Not RequiredPG - Any PG Course - Any Specialization,Post Graduation Not Required
Industry Type:
Pharma/ Biotech/Clinical Research
Regulatory Affairs Mgr
Functional Area:
Healthcare, Medical, R&D
Posted Date:
03 May

Desired Candidate Profile

Looking for a candidate with good experience in pharma industry.

Job Description

Please revert back with updated resume, current CTC, expected CTC, and current location as soon as possible.... Position is about to be closed in next 10 days...

Looking for Sr. Executive / Asst. Manager Regulatory Affairs candidates for API (Bulk drug)

Experience required: 3yrs+
Company: A leading pharma company based in Mohali and a complete(GBU -  Global Business Unit)

1. Good knowledge and understanding of the Regulatory guidelines like ICH, EMEA, EDQM, USFDA, MHLW, ASEAN, PIC, APIC and ISPE.
2 . Preparation of Drug Master File for USA, Europe, EDQM, Canada, Australia, Japan and ROW markets in accordance with the CTD and CMC guidelines.
3. Preparing high quality allocated QoS for API .

4. Timely submission of the updates of Drug master file to the authorities.

5. Providing response to the queries raised by Health Authorities or Regulatory Agencies for allocated API.

6. Continuously updating the knowledge of guidelines through permanent Training Process.

7. Work closely with the Regulatory agency team for delivery of documents for E-Submission.

8. Change notification to health authorities and Customers in accordance with USFDA, EMEA, EDQM, MHLW guidelines.
Keywords: Drug Regulatory, Regulatory Affairs, DMF

Company Profile

Beta Soft Systems, Inc. is a consulting company based at Fremont, CA, having offshore office in Panchkula, engaged with several fortune 500 companies nationwide. We are always looking forward to help professionals build a career in Best Industry by providing the opportunity to work with our top clients.
Contact Details
Company Name:
Beta Soft Systems Pvt. Ltd.
Executive Name:
Mehak Sharma
SCO-398, Sector-20
PANCHKULA,Haryana,India 134109


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