DGM/ GM – Regulatory Affairs | Biological E | Hyderabad

Job Description

DGM/ GM – Regulatory Affairs (Injectables)

Regulatory Affairs for Speciality Generic Injectables division

• Candidate must have worked in Injectable products submissions in USA/EU/RoW including complex generics

Roles & Responsibilities:

• To assist the product development and strategizing the regulatory pathway for drug substances/products.
  • Evaluation and drafting of regulatory strategy for global markets for generic and complex generic products
  • Controlled correspondences with the Agency, as applicable.
  • Evaluation of API DMFs open parts (Outsourced APIs) at the time of development.

   

• Responsible for review of various components (MFC, development report, specifications/stability protocols) of TTD documents for drug substance and drug product. 
• Assisting the Business Development/International marketing team in strategizing/evaluating the global regulatory strategies for various products under development/execution. 
• Review and Submission of DMFs/ANDAs/MAAs/Dossiers to US, EU & Rest of World markets. 
• Responsible to ensure compliance to routine Pharmacopeial updates. 
• Responsible for ensuring domestic licenses of Pharma. Manufacturing site and Test Licenses for R&D. 
• Responsible for updation of the cross-functional team w.r.t. routine Agency updates in terms of guidance, notification, and other generic approvals, etc. 
• Responsible for Electronic submissions and routine labeling activities. 
• Change control reviews and management. 
• Life cycle management of products. 
• Responsible for updation of Administrative activities linked to US/EU/RoW markets which include but are not limited to E-Submissions., Establishment registration, Self-ID, DUNS, FEI no. etc. 
• Provide on-the-job technical training to the regulatory team members.

Qualification: B.Pharma/M.Pharma