Reviewer – CMC Regulatory Affairs (SPD) | Topical & Derma Products | Aurobindo Pharma Hyderabad

Join Aurobindo Pharma as a CMC Regulatory Affairs – SPD Reviewer in Hyderabad. 2–5 yrs experience in topical/derma CMC SPD review. M.Pharm R&D interns welcome. Apply now!

📢 Now Hiring: CMC Regulatory Affairs – SPD Reviewer at Aurobindo Pharma, Hyderabad

Are you an M.Pharm professional with a passion for formulation R&D, especially in topical and derma specialty products? Do you want to accelerate your career in pharma regulatory affairs? Aurobindo Pharma Ltd. invites qualified candidates for the role of Reviewer – Regulatory Affairs (CMC – SPD) at our state-of-the-art APLRC1 facility in Bachupally, Hyderabad.

This is a high-paying pharma job opportunity for candidates with solid experience in CMC SPD review for topical and dermatology formulations. If you have 2–5 years of hands-on expertise or have completed an intensive R&D internship in specialty product development, this role is tailor-made for you.

🔍 Role Overview: CMC Regulatory Affairs – SPD Reviewer

• Position: Reviewer – Regulatory Affairs (CMC – Specialty Products Division)

• Location: APLRC1, Bachupally, Hyderabad, Telangana

• Department: Regulatory Affairs & CMC

• Reporting to: Head of CMC Regulatory Affairs

As a CMC SPD Reviewer, you will be responsible for evaluating Chemistry, Manufacturing, and Controls (CMC) sections in regulatory submissions for topical and derma products, ensuring compliance with global regulatory standards such as US FDA, EMA, and ICH guidelines.

📝 Key Responsibilities

1. CMC Document Review & Preparation

   • Review and finalize CMC sections (SPD module) for ANDA, NDA, and global filings

   • Prepare Quality Overall Summaries (QOS) and Drug Product Quality Reports

   • Compile stability data, batch records, and analytical method validation reports

2. Regulatory Strategy & Submission Support

   • Define regulatory filing strategies for topical and dermatology formulations

   • Liaise with cross-functional teams (R&D, Production, QA/QC) to gather technical inputs

   • Track submission timelines and manage eCTD lifecycle

3. Compliance & Gap Analysis

   • Conduct gap assessments against ICH Q8–Q11, US FDA, EMA, and other global regulations

   • Implement corrective and preventive actions (CAPA) for CMC deficiencies

   • Maintain up-to-date knowledge of regulatory affairs best practices

4. Stakeholder Collaboration

   • Coordinate with CMC scientists, analytical development, and manufacturing teams

   • Interact with regulatory authorities during queries and audits

   • Provide training and guidance to junior team members

🎯 Who Can Apply?

1. Mid-Level Professionals

• Experience: 2–5 years in reviewing CMC SPD for topical/derma products

• Qualification: M.Pharm (specialization in Pharmaceutics or Pharmaceutical Technology)

2. R&D Intern Alumni

• Internship: 9–12 month internship in Formulation R&D – Specialty Products, with a focus on topical or dermatology formulations

• Qualification: Fresh M.Pharm graduates with documented internship deliverables

3. Essential Skills & Keywords

• Strong CMC document drafting and regulatory writing skills

• Hands-on experience with stability studies, analytical method validation, and batch records

• Expertise in eCTD submissions, regulatory gap analysis, and global filing requirements

• Familiarity with ICH guidance, US FDA cGMP, EU GMP, and ANDA/NDA guidelines

• Excellent communication and cross-functional collaboration abilities.

🌐 Why Aurobindo Pharma?

• Global API & Generics Leader: Supplying APIs to 80% of the top 50 pharma companies worldwide.

• 80+ Years of Legacy: Trusted expertise in generic APIs and specialty formulations.

• Cutting-Edge Facilities: State-of-the-art R&D, manufacturing, and regulatory affairs centers.

• Career Growth: Structured programs for professional development, global rotations, and leadership tracks.

• Competitive Compensation: Attractive salary packages, performance bonuses, and comprehensive benefits.

📈 Career Progression & Benefits

1. Professional Development:

   • Access to regulatory workshops, global conferences, and ICH training modules.

2. Cross-Functional Exposure:

   • Work with R&D, Quality, Manufacturing, and Global Regulatory Affairs teams.

3. Leadership Pathways:

   • Fast-track to Team Lead or Manager – CMC Regulatory Affairs for high performers.

4. Work-Life Balance:

   • Flexible hybrid work options, employee wellness programs, and continuous learning support.

🗺️ Location & Workplace

• Facility: APLRC1 – Bachupally, Hyderabad

• Accessibility: Well-connected by road and metro; on-site canteen and modern amenities.

• Work Culture: Collaborative, innovation-driven, with a strong focus on quality and compliance.

✉️ How to Apply

Interested candidates should share their updated resume with the subject line “Application for CMC – RAD – SPD” to:

• Email: sreeja.yangam@aurobindo.com

Please include: cover letter, internship reports (if applicable), and any relevant publication or project summaries.

🏁 Ready to Elevate Your Pharma Career?

If you’re driven by regulatory excellence, specialty product innovation, and global submission strategies, this CMC Regulatory Affairs – SPD Reviewer role at Aurobindo Pharma offers the perfect platform. Don’t miss this opportunity to join a global leader and make an impact in topical and derma product regulation.

👉 Apply today and take the next step toward a rewarding career in pharma regulatory affairs!