Team Member – Regulators Affairs – Formulations (oral Solids)

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3 – 8 Years


Hyderabad / Secunderabad

Job Description

Participate in the regulatory activities of full spectrum of formulation development, from clinical trials to marketing to post approval activities.
Ensure the appropriate licensing, marketing and legal compliance of the finished dosages.
Review the documents at each stage of formulations development.
Highlight the regulatory issues that can be there and try to resolve them.
Coordinate with R&D, AR&D, QA, etc. to collect the complete set of documents.
Compile the ANDA document to be submitted to FDA.
Ensure the documents are error free and have minimum deficiencies.
Prepare annual reports and send them to FDA.
Manage change controls and deviation controls.
Keep themselves abreast of international legislation, guidelines and customer practices
Develop and write clear arguments and explanations for new product licenses and license renewals.
Advise PDTs on regulatory requirements.
Respond to the queries of Regulatory authorities and customers on time.
Review the process change proposals and provide guidance on change proposals.

Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Other


Desired Profile

Education:UG -B.Pharma – Pharmacy
PG – M.Pharma – Pharmacy
Doctorate – Doctorate Not Required

Company Profile

Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Major therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management and anti-infective. Major markets include India, USA, Russia-CIS and Europe apart from other select geographies within Emerging Markets. For more information, log on to:
Contact Details

Recruiter Name:Not Mentioned

Contact Company:Dr Reddys Laboratories Ltd

Telephone:Not Mentioned


Source by naukri….