Regulatory Affairs Job at Lifecell International Private Limited

The company is the most accredited stem cell bank with certifications from national and international organizations for standards. LifeCell is also the only player in the industry providing comprehensive stem cell solutions including the novel initiative of community stem cell banking, R&D and point-of-care stem cell therapy for orthopaedic and vascular specialities. LifeCell established its Diagnostics division in 2017 providing India’s most comprehensive diagnostic program for mother & baby care, offering preconception, prenatal and newborn testing services to address the challenge of high infant mortality rate in the country as well as promote health and wellness for generations to come. Finally, in 2018, LifeCell Introduced its Biologics division by launching a series of products derived from placental tissues which have well-established applications in clinical settings to provide solutions that enhance patient life expectancy and reduce global disease burden.

Post : Sr. Executive / Executive Regulatory Affairs - 02

Job Responsibilities
• Registration and Licensing activities with CDSCO
• Preparation & Compilation of IND/NDA
• Review of Pre-clinical and/or clinical trial protocol(s) and reports(s)
• Review and compilation of CMC documents
• Establish and Implementation of regulatory knowledge centre on advanced therapy medicinal products
• Handling of query responses
• Writing letter to authority w.r.t request for designation
• Coordinate with national regulatory authority

Skills Required
• This challenging opportunity is to candidates who have open to work on Regenerative medicinal products on stabilized period.
• Candidate must have dossier filing experience with CDSCO/USFDA
• Have experience on Pharma or Biosimilars or Cell lines
• Have experience on writing of CMC writeups, Clinical summary reports
• Preferably who have experience in regulatory science of Pharma & Cosmetics

Additional Information
Experience : Min 3-5 years
Qualification : M.Pharm
Location : Chennai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 15th April, 2021