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Regulatory Affairs - (Us/Eu/Ca)

Shilpa Medicare Ltd.
Shilpa Medicare Ltd.
2-5 years
₹4.2 – ₹8.5 LPA
10 July 21, 2025
Job Description
Job Type: Full Time Education: M Pharm/B Pharm Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Opportunity: Regulatory Affairs (US/EU/CA) – Shilpa Medicare Ltd, Hyderabad

Location: Hyderabad (IDA Mallapur, Nacharam, Telangana)
Company: Shilpa Medicare Ltd.
Department: Regulatory Affairs – US / EU / Canada
Interview Date: Saturday, 26th July 2025
Time: 10:00 AM to 02:00 PM
Email (for those unable to attend):
karthik.kumar@vbshilpa.com

Open Positions:

  • Executive

  • Sr. Executive

Eligibility Criteria:

  • Qualification: M.Pharm / B.Pharm

  • Experience: 2 to 5 years

  • Requirement: Candidates must have formulation-relevant experience

Key Responsibilities:

  • Preparation, compilation, and review of regulatory dossiers for US, EU, and Canada markets

  • Working with CTD and country-specific formats for submissions

  • Ensuring compliance with international regulatory guidelines

  • Coordinating with technical and quality teams for data collection and documentation

Documents to Carry:

  1. Updated Resume

  2. Recent Increment Letter / Offer Letter with CTC breakup

  3. Last 3 Months’ Pay Slips & 6 Months’ Bank Statement

  4. Copies of all Educational Certificates

  5. Copy of Aadhar & PAN Card

Interview Venue:
Shilpa Medicare Ltd.
Plot No. 79, Road No. 15,
Survey No. 125, IDA Mallapur,
Nacharam, Uppal Mandal,
Telangana – 500076

Estimated Salary: ₹4.2 – ₹8.5 LPA (based on experience and position)