Asst. Manager / Executive – Regulatory Affairs

Summary

Experience:

3 - 5 Years

Location:

Mumbai

Education:

UG - B.Pharma - Pharmacy,B.Sc - Any SpecializationPG - M.Pharma - Pharmacy,M.Sc - Any Specialization

Industry Type:

Pharma/ Biotech/Clinical Research

Role:

Regulatory Affairs Mgr

Functional Area:

Healthcare, Medical, R&D

Posted Date:

10 Apr

Desired Candidate Profile

Thorough knowledge of FDA regulation of India and Third Countries ,Drugs and Cosmectics Acts and rules of India and also regulatory guidelines.

•Must be from Science / Pharmacy background with Min 2 Years of Experience in same line

• Excellent command over written and verbal English communication.

• Must be Proficient in Computer skills and business communication

• Should be self motivated and result oriented

• Should be initiator , keen learner , proactive and good analytical skills

• Should have pleasing and presentable personality.

 

Job Description

-Knowledge of Regulatory requirement for different countries (For Regulated / Non regulated Market)

- 3-5 year experience in Regulatory related work.

-Knowledge of latest guidelines of all countries

-Good coordination skill with related department

-Task oriented with learning attitude.

-Knowledge of preparation & compilation of dossiers for various

countries along with legal documentations.

-Product knowledge.

-Hands of experience in QC/ Production

 

Keywords: DRA, Regulatory, Documentation, Regulatory Affairs, Sr. Regulatory Executive, Registration,Import Licensing,Export Licensing,DCGI,CDSCO,FICCI.

Company Profile

Rusan is a research driven pharmaceutical company having its Manufacturing Units in India and Worldwide Marketing of Pharmaceutical Formulation, Active Pharmaceutical Ingredients and Intermediates. 

The company has its own Research & Development centre at Kandivli (west), Mumbai, state of the art, Bulk Manufacturing Plant at Ankleshwar and Formulation plant at Dehradun and SEZ, Kandla having approval of MHRA (UK), MCC (SA) and other International Health Authorities.

March 2009 - 70 Crs. Expected by March 2010 – 120 Crs.

Contact Details

Company Name:

Rusan Pharma Ltd

Website:

http://www.rusanpharma.com

Executive Name:

Mr. Deepak

Address:

Not Mentioned

Email Address:

kdeepak@rusanpharma.com

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