One of our clients, a globally operating European pharmaceutical company that develops, manufactures and markets human and veterinary pharmaceuticals, active pharmaceutical ingredients and diagnostic tests. The company employs more than 3,000 professionals in different countries have the following opening:-
Sr.Executive / Executive / Sr.Officer - Regulatory Affairs
Job Description and Responsibilities:-
To be responsible for the Life Cycle Management of assigned products, preparation of pharmaceutical/quality part (all forms) of registration dossiers and variations/amendments/annual reports as applicable documents in CTD and eCTD format according to EU regulatory requirements.
To write, check/review of documents as per regulatory requirements
To publish with software submission documentation as per regulatory requirements
To response to regulatory deficiencies letters according to EU and USA regulatory requirements.
To support local in-licensing
To collaborate with other departments/partners
To maintain lists/documents/records
To achieve his/her responsibilities within the agreed timescales
To actively participate in the development of regulatory skills within the regulatory team by continuous up-dating.
Primary Skills (essential)
4 - 8 years' work experience in international regulatory affairs from Pharma industry and Confirmed knowledge of EU requirements and ICH guidelines.
Experience in Formulations Analytical Development, Formulations Development or Pharmaceutical product development activities and eCTD submissions will be an added advantage.
Fluency in oral and written English
Task oriented with learning attitude and Team work skills
Familiarity with Microsoft Office
Salary: INR 5,00,000 - 7,50,000 P.A. All employee benefits & perks as applicable to pharma Mnc's, 5 day week
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology
Role Category:Drug Regulatory Affairs/Documentation
Role:Regulatory Affairs Manager
Employment Type: Permanent Job, Full Time
Desired Candidate Profile
M.Pharm / B.Pharm / M.Sc / B.Sc Graduates with 3+ years experience in the drug regulatory affairs functions for the export of finished formulations to the EU / US markets. Must be a resident of Mumbai / Navi Mumbai /Thane
UG: B.Sc - Any Specialization, B.Pharma - Pharmacy, BAMS - Any Specialization, BHMS - Any Specialization, Other Graduate
PG:Any Postgraduate - Any Specialization
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S.M.College of Memory
European pharma MNC having offices & operations in more than 20 countries in Europe as well as in India and China. The manufacturing operations are in Europe. Outside Europe, the important markets include the United States, the Latin America, Middle East and North Africa as well as Asia Pacific. In R&D, this company has built an international network of best-in-class partners around its core therapy areas. Partnerships are also a key component of the company's supply chain.
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