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Dr. Reddy’s Laboratories is seeking a highly skilled and experienced professional to join our team as a Subject Matter Expert (SME) – Quality Regulatory Compliance / Regulatory Response Writing in Hyderabad. If you have expertise in regulatory requirements and technical writing, we invite you to apply for this exciting opportunity.
Company: Dr. Reddy’s Laboratories
Location: Hyderabad, Telangana
Job Details
Role: SME – Quality Regulatory Compliance / Regulatory Response Writing
Location: Hyderabad, Telangana
Job Description
We are looking for a dynamic professional to lead our regulatory compliance efforts, with a focus on crafting high-quality regulatory responses and ensuring adherence to global standards.
Key Responsibilities
- Demonstrate expertise in regulatory requirements, including USFDA, EMA, ICH, EU GMP, MHRA, ANVISA, Schedule-M, WHO, TGA, Health Canada, PDA, and APIC.
- Apply knowledge of quality management principles such as GMP, GLP, and ISO standards.
- Lead technical writing and content development for regulatory responses, including FDA observation responses.
- Craft clear, succinct, and logically structured documents that effectively communicate corrective actions and compliance strategies.
Qualifications
- Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related field.
Experience
- 15 to 17 years of experience with a strong understanding of regulatory requirements, regulatory response writing, and communication.
Position Summary
| Category | Details |
|---|---|
| Role | SME – Quality Regulatory Compliance / Regulatory Response Writing |
| Qualification | B.Pharm / M.Pharm / B.Sc / M.Sc in Pharmacy, Pharmaceutical Sciences, Chemistry, or related field |
| Experience | 15 to 17 years |
| Location | Hyderabad, Telangana |
Why Join Dr. Reddy’s Laboratories?
At Dr. Reddy’s, you’ll contribute to our mission of delivering high-quality healthcare solutions globally. This role offers the opportunity to work in a fast-paced, innovative environment while shaping regulatory compliance strategies that impact the industry.
How to Apply
Interested candidates are invited to share their resumes with us. Please send your updated CV to:
We look forward to reviewing your application and welcoming a talented professional to our Hyderabad team!