Tata Consultancy Services (TCS) is a software services consulting company headquartered in Mumbai, India. TCS is the largest provider of information and business process outsourcing services in Asia. TCS is a flagship subsidiary of one of India's largest and oldest conglomerate company, the Tata Group, which has interests in areas such as energy, telecommunications, financial services, manufacturing, chemicals, engineering, materials, government and healthcare.
Post : Regulatory Affairs Manager
Job Purpose:
- Responsible for the project management of regulatory maintenance of a specific product portfolio through the management of global submissions (PSUR’s, PBRER’s, Labelling Update Variations, License renewals and Annual Reports and associated Health Authority Questions).
- Responsible for maintaining knowledge of Sponsor’s Regulatory operations / procedures.
- Experience:
- years of experience in Pharma/ Biotech company in regulatory domain.
- Experience with Global regulatory submissions of one or more of the following regions:
- EU/ US/ Japan (ICH)
- Rest of the World Markets (with emphasis on China and Brazil).
Candidate Profile
MASTER OF PHARMACY
Additional Information:
Experience: 6+ years
Qualification: M. Pharm
Location: Mumbai
Industry Type: Pharma/Biotech/Clinical Research
Job Function : BUSINESS PROCESS SERVICES
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