Jobs in Regulatory Affairs -Executive /senior Executive Plasmagen Biosciences Pvt. Ltd. is a biopharmaceutical company which focuses on plasma protein therapy . It Provides a wide range of plasma products to enhance the health and quality of life of patients.The company is having clear vision in plasma protein industry in India and SAARC nations .
The company is having openings in regualtory affairs . Interested candidates can check the details below
Job Description
This role will support the regulatory activities required for management of Pharma Products and Human Plasma Products for Emerging Markets.
-Good Knowledge on the regulatory Requirements of the following emerging markets
1. India , South East Asian and ROW markets
2. LATAM
- The candidate Should be able to prepare and Review the Dossiers for the markets refered above.
- Arranging and examining art-works of products for registration
- Handling queries & deficiencies regarding submitted products
- Maintaining Product registration status for all countries (country wise / person wise)
- Finding guidelines of registration for different emerging countries
- Updating Regulatory Requirements for human plasma products and pharma in Emerging Markets.
- The candidate must Co-ordinate with the Contract Manufacturers to obtain the documents required for submission.
- The candidate must have Knowledge on the legal and technical documentation requirements, Timelines and validity periods for Registration of products.
Experience required : 3 - 7 years
Location : Bengaluru(Chamarajapet)
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