PHARMA BHARAT
PHARMACEUTICAL JOB PORTAL
No new notifications

Ad

Bachwell Pharma Hiring for Regulatory Affairs & Engineering | 0 – 7 Years

Published on

Ad

Bachwell Pharma has announced multiple job openings for freshers and experienced candidates in Regulatory Affairs and Engineering departments at Hyderabad, Telangana. The company is inviting applications from M.Pharm, M.Sc, and graduate candidates for US/EU Regulatory Affairs, CDSCO/DCGI Regulatory Affairs, and Engineering Process Maintenance roles.

Candidates looking for Regulatory Affairs jobs in Hyderabad, Pharma jobs for freshers, DRA jobs in India, eCTD submission jobs, CDSCO regulatory jobs, and pharma engineering careers can apply through email.


Available Positions at Bachwell Pharma

1. Regulatory Affairs Associate Trainee โ€“ Freshers

  • Position: RA Associate / Trainee โ€“ Drug Regulatory Affairs
  • Department: Regulatory Affairs
  • Experience: Freshers
  • Vacancies: 3
  • Location: ALEAP, Pragathi Nagar, Hyderabad
  • Qualification: M.Pharm / M.Sc (Regulatory Specialization)

Key Responsibilities

  • Dossier compilation and eCTD module support
  • Preparation of Module 2 and Module 3 documents
  • Technical data verification and CMC documentation
  • Stability data monitoring as per ICH guidelines
  • Support ANDA and MAA submissions
  • Labeling and artwork compliance
  • Regulatory intelligence tracking for US FDA and EMA guidelines

Skills Preferred

  • Knowledge of eCTD submissions
  • Understanding of FDA and EMA regulations
  • Basic knowledge of CMC documentation
  • Good documentation and analytical skills
  • Attention to detail in regulatory submissions

2. Research Associate โ€“ Drug Regulatory Affairs (CDSCO/DCGI)

  • Position: Research Associate โ€“ Drug Regulatory Affairs
  • Experience: 3โ€“7 Years
  • Vacancies: 2
  • Location: ALEAP, Pragathi Nagar, Hyderabad
  • Qualification: M.Pharm / M.Sc (Regulatory Specialization)

Key Responsibilities

  • Regulatory dossier preparation for domestic market
  • SUGAM portal submission handling
  • Form 44 and CDSCO documentation management
  • Product lifecycle and post-approval variations
  • Artwork and labeling compliance review
  • Coordination with QA, R&D, and Production teams
  • Regulatory query response management
  • SEC meeting documentation support

Preferred Expertise

  • CDSCO and DCGI regulatory knowledge
  • Hands-on experience with SUGAM portal
  • Knowledge of Drugs & Cosmetics Rules
  • Experience in regulatory compliance and submissions

3. Executive โ€“ Engineering Process Maintenance

  • Department: Engineering โ€“ Process Maintenance
  • Experience: 2โ€“5 Years
  • Vacancies: 2
  • Location: Pashamylaram IDA, Hyderabad
  • Qualification: Any Graduation

Key Responsibilities

  • Preventive maintenance of packaging equipment
  • Breakdown troubleshooting and repair
  • Calibration and instrumentation activities
  • Vendor coordination and spare inventory management
  • Equipment qualification and validation support
  • Serialization and vision system maintenance
  • Audit readiness and compliance documentation

Preferred Skills

  • Experience in pharma packing machinery
  • Knowledge of IQ/OQ/PQ validation
  • Understanding of 21 CFR Part 11 compliance
  • Experience with packaging lines and automation systems

Why Join Bachwell Pharma?

  • Opportunity to work in global regulatory markets
  • Exposure to US FDA, EMA, CDSCO, and DCGI regulations
  • Hands-on experience with eCTD and regulatory submissions
  • Career growth in pharmaceutical regulatory affairs
  • Learning opportunities in validation and compliance
  • Exposure to global pharmaceutical manufacturing standards

How to Apply

Interested candidates can send their updated CV to:

WhatsApp Contact: +91 9014502249

Candidates are advised to mention “Pharmabharat” as Reference the applied position in the email subject line.

Ad

Share This Job

โœ… Job Details Copied!