Executive Regulatory Affairs
by Concept Pharmaceuticals Ltd in Mumbai, Aurangabad
Experience: 2 to 3 yrs. | Salary: INR 2,00,000 - 3,00,000 P.A | Opening(s): 2 Posted on: 11 Sep
Job Description
- Responsible for coordination & timely preparation of regulatory submission - Complete filling of forms & requests applicable to regulatory agencies
- Preparation of response to the regulatory queries & deficiencies
- Preparation & review of technical documents such as Master production & control documents, analytical method validation protocol & report, Process validation protocol & report, Finished product specification complying with regulatory norms, stability protocol & report
- To provide regulatory input in the various functions
- Preparation of regulatory audits & inspection
- To develop & update regulatory knowledge of European & US regulations
- Preparation of response to the regulatory queries & deficiencies
- Preparation & review of technical documents such as Master production & control documents, analytical method validation protocol & report, Process validation protocol & report, Finished product specification complying with regulatory norms, stability protocol & report
- To provide regulatory input in the various functions
- Preparation of regulatory audits & inspection
- To develop & update regulatory knowledge of European & US regulations
Salary: INR 2,00,000 - 3,00,000 P.A
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Drug Regulatory Affairs/Documentation
Role: Regulatory Affairs Manager
Keyskills: Regulatoryregulatory affairs
Desired Candidate Profile
Education:
UG - B.Pharma - Pharmacy
PG - M.Pharma - Pharmacy
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
PG - M.Pharma - Pharmacy
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
Experience: 2 to 3 years in the preparation of regulatory submission and regulatory inspection for getting ROW , US & EU marketing authorization. And should have extensive experience in regulatory field.
Competencies:
- Careful planning to achieve accurate & timely results
- Work precisely according to procedures, rules & regulations
- Recognise recurring issues and analyse their causes in order to resolve the issues
- Support a culture of high performance & trust
Competencies:
- Careful planning to achieve accurate & timely results
- Work precisely according to procedures, rules & regulations
- Recognise recurring issues and analyse their causes in order to resolve the issues
- Support a culture of high performance & trust
Company Profile
Concept is an integrated pharmaceutical company that is completing 25 years of incorporation. Earlier part of the Lupin group, as an independent entity has diversified activities in Formulations, Bulk Drugs, Veterinary and Herbal businesses.
Contact Details
Recruiter Name:Neha Joshi
Contact Company:Concept Pharmaceuticals Ltd
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