By admin 
Biological E. Limited is hiring for #RegulatoryAffairs#, Pharma SGI-USFDA Approved plant, Shamirpet location, Hyderabad.
Position: Executive/Sr. Executive
Qualification: M.Pharmacy
Experience: 4 to 9 years
Job Description:
*Review of all the relevant documents related to product development (development/tech-transfer) and submission batches.
*Co-ordinate with various cross functional teams for formulization of dossier and other applicable submissions as the case may be.
*To collate and compile dossier as per CTD requirement and any related submissions as per filing plan.
*Compilation of DMF as per regulatory requirements and submission to the Agencies.
*Formalization of dossier in NeeS/electronic format and validation of the same using e-validators.
*To understand and interpret various regulatory guidance documents.
*Handling and responding to all product specific queries arising from various customers and regulatory authorities.
*Review and submission of required product information and mock-ups to MOH during the procedure, per the country regulations.
*Ensure relevant SOP’s are understood and practiced on routine basis.
*To maintain and handle product life cycle management under direct supervision of supervisor/head.
*Change Control approval activity in compliance with regulatory requirements & maintenance of change control tracker.
Interested aspirants with relevant skills set can share their resumes to Mahesh.Patsamatla@biologicale.com