Work as Regulatory Affairs Executive at Ultratech India Limited

Ultratech India Limited is an integrated pharmaceutical and life sciences company engaged in manufacturing pharmaceutical finished dosage forms, Active Pharmaceutical Ingredients and providing drug discovery solutions. Ultratech specializes in development and manufacturing of pulmonary drug delivery systems and offers a complete range of anti-asthmatic inhalation drugs in Dry Powder Inhalation and Pressurized Metered Dose Inhalation dosage forms.

Post : Regulatory Affairs Executive

Job Description
• Preparation of DMFs for regulated markets
• Preparation & filings of COS / CEP / EDQM
• Responsible for compilation of Non-Clinical and Clinical parts of CTD according to published data.
• To conduct reference study search on internet for accumulating comparative technical data of various Intermediates & APIs for preparation of DMFs
• Preparing of various technical documents required for regulatory filings
• Preparation of all base documents and Filing regulatory documents like DMF and COS / CEP / EDQM for obtaining Country specific registrations with various Health Authorities
• Providing response to technical queries pertaining to DMFs
• Preparation of all supporting documents and Filing for State FDA, CDSCO licenses.

Candidate Profile
• Preparation of API DMF for regulated markets
• Thorough experience of preparation of DMFs, filing for COS / CEP /EDQM
• Thorough Awareness of updated regulatory guidelines for registration of products in EU, ANVISA, Ukraine, UK , Japan, Philippines, Russia

Additional Information
Experience : 3 years in preparing DMF or Dossiers
Qualification : Bsc Chemistry / MSc - Analytical chemistry / Organic Chemistry
Good written English proficiency with Min 3 years
Location : Taloja, Navi Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs documentation
Salary : 3.5 lacs p.a. to 5.0lacs p.a.
End Date : 25th June, 2021