WhatsApp Group
Join Now
WhatsApp Channel
Join Now
Telegram Group
Join Now

Advertisement

Sun Pharmaceuticals Hiring for FRD Non-Orals and Regulatory Affairs

Published on

Sun Pharma

M.Pharm

Baroda

1 - 6 Years

Verified Job

Online Application
Advertisement

Sun Pharmaceutical Industries Ltd., India’s largest pharma company, has announced three major job openings in Tandalja – R&D, Baroda. These opportunities are ideal for candidates seeking high-growth roles in Formulation R&D (FRD), Non-Oral Dosage Forms, and Regulatory Affairs (RA).

These positions offer exposure to MDI formulations, microspheres, long-acting injectables, ANDA documentation, regulatory submissions, and collaboration with cross-functional development teams. If you’re looking to advance your pharma career, this is one of the best times to join Sun Pharma’s innovation-driven R&D environment.


1. Senior Executive / Executive – FRD Non-Orals (MDI)

Key Responsibilities

  • Prepare and execute MDI formulation development experiments.
  • Conduct pre-formulation & prototype development for stability and method validation.
  • Prepare documents for API/innovator import, manufacturing license, and testing approvals.
  • Coordinate procurement of API, excipients, packaging, and innovator samples.
  • Develop product development protocols & reports.
  • Prepare stability protocols, test requests, and technical documentation.
  • Support scale-up, exhibit, and clinical batches at plant/CMO sites.
  • Prepare regulatory submission documents and respond to agency queries.
  • Draft and review SOPs, investigational reports, and OOS/OOT justifications.
  • Ensure compliance with internal quality systems.

Qualifications

  • M.Pharm
  • 2–6 years experience in MDI or non-oral formulation development.

2. Executive – Regulatory & Business Continuity (RA)

Key Responsibilities

  • Support new submissions by coordinating with Product Development and CFTs.
  • Review documents and guide teams on regulatory strategy and dossier requirements.
  • Prepare and submit high-quality regulatory dossiers for faster approvals.
  • Submit meeting packages for agency scientific discussions.
  • Address regulatory deficiencies and obtain product approvals.
  • Manage lifecycle activities:
    • Annual reports & renewals
    • Product variations & supplements
    • Regulatory compliance at DF plants
    • Central repository updates
  • Stay updated with global regulatory guidelines and present internally.

Qualifications

  • M.Pharm
  • 2–5 years experience in regulatory affairs.

3. Executive – FRD Non-Orals (Microspheres / Long-Acting Injectables)

Key Responsibilities

  • Design & execute experiments for microspheres, implants, in-situ gels, and LA injectables under QbD.
  • Run studies using DoE and record data in eLNB/METIS.
  • Perform literature search and prepare ANDA summaries & reports.
  • Compile results using MINITAB and prepare scale-up reports.
  • Develop Technology Transfer (TT) documents, risk assessments, and CPP/CQA justifications.
  • Prepare Form 29, CPD, stability protocols, and scientific justifications.
  • Participate in equipment qualification and SOP creation.
  • Collaborate with ADD, RA, CQA, and manufacturing plants.

Qualifications

  • M.Pharm
  • 1–3 years experience in complex non-oral formulations.

Benefits of Working at Sun Pharma

  • Growth-oriented R&D ecosystem
  • Exposure to global regulatory & formulation projects
  • Supportive & collaborative workplace culture
  • Opportunities to work on cutting-edge non-oral and inhalation formulations
  • Strong focus on innovation & career progression

How to Apply

Application Link For Senior Executive / Executive – FRD Non-Orals (MDI)

Advertisement

Application Link For Executive – Regulatory & Business Continuity (RA)

Application Link For Executive – FRD Non-Orals (Microspheres / Long-Acting Injectables)

Advertisement

Share This Job

✅ Job Copied Successfully!

Ad Popup