Aurobindo Hiring Regulatory Affairs

Regulatory Affairs CMC (M.Pharm) – US & EU | Hyderabad

Aurobindo hiring Regulatory Affairs (CMC) for US & EU markets. M.Pharm required. Apply for OSD, topical, nasal formulation roles in Hyderabad.

Aurobindo Pharma Research Centre‑I is holding a targeted hiring drive for Regulatory Affairs professionals with proven CMC experience for US and EU markets. We are looking for candidates who bring hands‑on dossier preparation skills, lifecycle management experience, and a practical understanding of complex oral and topical product filings. These roles are critical for ensuring global regulatory compliance and accelerating product approvals across major markets.

Company Overview

Aurobindo Pharma is a global pharmaceutical leader with end‑to‑end capabilities across R&D, manufacturing, and regulatory operations. The APL Research Centre‑I in Hyderabad supports advanced formulation development, regulatory strategy, and submission readiness for global markets. The company is committed to quality, data integrity, and regulatory excellence—making it an ideal workplace for regulatory scientists focused on CMC documentation, ANDA/NDA strategies, and lifecycle management.

Job Role & Responsibilities

Regulatory Affairs – CMC (US & EU markets)

We have openings across two focused streams: US (RAD‑US) and EU (RAD‑EU). Candidates will handle CMC dossier preparation, submissions, and post‑submission activities for solid oral dosage (OSD) and complex formulations.

RAD‑US (US Market) — Experience: 3–10 yrs

• M.Pharm in Regulatory Affairs, Pharmaceutics, or Pharmaceutical Analysis preferred.
• Hands‑on experience with ANDA (approved and tentative), NDA supplements, and post‑approval CMC activities.
• Prepare and file CBE, CBE‑30, PAS, Controlled Correspondence, and annual reports/updates.
• Respond to USFDA queries, coordinate controlled correspondence, and manage submission timelines.
• Support complex OSDs, topicals, and nasal formulation regulatory strategies where applicable.

RAD‑EU (EU Market) — Experience: 2–10 yrs

• M.Pharm in Regulatory Affairs, Pharmaceutics, or Pharmaceutical Analysis preferred.
• Expertise in Module 2 (Quality Overall Summary) and Module 3 (History of API and Drug Product) of CTD for EU submissions.
• Prepare initial dossiers, variations, and lifecycle management documents for EU member states and centralized submissions as required.
• Support dossier compile, CMC technical writing, and pre/post submission activities for OSDs and nasal/topical products.

Common CMC Responsibilities:

• Compile and author CMC sections (M2 & M3), including specifications, manufacturing process descriptions, controls of materials, and stability data.
• Draft and review validation protocols and reports (process validation, hold time studies) and support technical sections of regulatory submissions.
• Conduct internal gap analysis and ensure dossier completeness before submission.
• Liaise with R&D, Quality, Manufacturing, and Analytical teams to gather technical inputs and ensure data integrity.
• Maintain up‑to‑date knowledge of US FDA and EU regulatory guidelines, ICH Q series, and region‑specific CMC expectations.

Eligibility / Qualifications

Essential:

• M.Pharm (Regulatory Affairs, Pharmaceutics, Pharmaceutical Analysis) or equivalent.
• Relevant experience in CMC regulatory affairs for OSD (tablets/capsules) — US experience for RAD‑US; EU experience for RAD‑EU.
• Strong technical writing skills and experience preparing CTD sections (M2 & M3).

Desirable:

• Exposure to complex OSD, topical/dermatological, or nasal formulations.
• Familiarity with ANDA, NDA supplements, and EU variations and decentralized procedures.
• Understanding of ICH guidelines (Q1‑Q14), stability protocol requirements, and GMP implications for submissions.

Relevant courses (comma‑separated): Regulatory Affairs, Pharmaceutics, Pharmaceutical Analysis, Quality Assurance, Drug Development, Pharmaceutical Technology.

Location & Salary

Interview Venue & Work Location:
APL Research Centre‑I, Sy. No. 313, Qutubullapur, Bachupally, Hyderabad, Telangana – 500090
Interview Date & Time: 14 December 2025 (Sunday) | 9:00 AM – 3:00 PM
Salary: Competitive and commensurate with experience; Aurobindo offers market‑aligned packages and performance incentives.

(Map/registration available via the QR code in the original post.)

Application Process

Scan the QR code on the advert to register for the walk‑in, or send your CV directly to the recruitment contacts:
• Sreeja Yangam: Sreeja.Yangam@aurobindo.com
• Pooja Uppalapati: Pooja.Uppalapati@aurobindo.com

Please mention the role of interest (RAD‑US / RAD‑EU) in your email subject line and attach an updated CV highlighting CTD/CMC experience.

FAQs

Q: Which formulations are in scope?
A: Primarily solid oral dosage forms (tablets, capsules). Candidates with experience in topical/dermatological and nasal formulations (especially for RAD‑EU roles) will be advantaged.

Q: Is M.Pharm mandatory?
A: M.Pharm in a relevant stream is strongly preferred. Equivalent qualifications with demonstrable regulatory experience may be considered.

Q: Will I work on ANDAs and NDAs?
A: Yes. RAD‑US roles include ANDA and NDA supplement activities; RAD‑EU focuses on CTD dossier preparations and EU lifecycle management.

Q: What experience level is appropriate?
A: RAD‑US: 3–10 years. RAD‑EU: 2–10 years. Candidates should have demonstrable CMC experience in the specified region.

Q: How does this role support healthcare outcomes?
A: Regulatory CMC professionals ensure drug quality, stability, and manufacturing consistency—directly supporting safe, effective medicines reaching patients globally.

Summary Table

Category	Details
Company	Aurobindo Pharma Ltd (APL Research Centre‑I)
Vacancies	Regulatory Affairs – CMC (RAD‑US & RAD‑EU streams)
Required Education	M.Pharm (Regulatory Affairs, Pharmaceutics, Pharmaceutical Analysis)
Experience	RAD‑US: 3–10 yrs; RAD‑EU: 2–10 yrs