Regulatory Affairs- EU Market

2 weeks ago


Hyderabad, Telangana, India V3 Staffing Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Greetings of the day

Our reputed MNC Client is hiring for:

Designation: Regulatory Affairs- EU Market- Pre & Post Approval

Location: Hyderabad

Shift: General

Work Mode: WFO (5 days working)

Interview Mode: F2F interview

NOTE: Looking for candidates from Generic Pharma and not from API as this is for formulation

Role & responsibilities:

  1. Component with EU-Filing requirements with respect to Module 2 & 3 ability to independently and correctly review technical documents related to Quality Module

  2. Well versed with EU- Regulatory guidance and Processes (i.e. Ability to understand and interpret technical expectations as per applicable ICH & EMEA guidelines)

  3. Clear Knowledge of basic aspects of a formulation (primarily pharmaceutical development along with general analytical aspects) for effective review of R&;D documents

  4. Should be aware of post approval variation requirements in EU markets. Should have basic QA knowledge to enable correct review of plant related documents

Key specifications/ Work exposure

  • Core Europe Experience in M2, M3 within pharma industry & RA formulations
  • FRD/FARD/QA Experience + Minimum 1 yrs of Exp in Regulatory Europe(EU) market.

Warm Regards,

Gayatri Kumari

Email Id:

V3 Staffing Solutions



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