10:59 AM
Leo Group India
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
- 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:
Executive Name:
Mr. Deepak
Address:
Not Mentioned
Email Address:
Posted in: regulatory rusanpharma
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