Aurobindo – Walk-Ins for Regulatory Affairs (Oral Solids) – CMC

Founded in 1986 by Mr. P. V. Ramprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born of a vision. The company commenced operations in 1988-89 with a single unit manufacturing Semi-Synthetic Penicillin (SSP) at Pondicherry. Aurobindo Pharma became a public company in 1992 and listed its shares on the Indian stock exchanges in 1995. In addition to being the market leader in Semi-Synthetic Penicillins, it has a presence in key therapeutic segments such as neurosciences, cardiovascular, anti-retrovirals, anti-diabetics, gastroenterology and anti-biotics, among others

Vacancy Details

• Department: Regulatory Affairs (Oral Solids) – CMC
• Experience: 04 to 10 Years
• Specification: Must have a good exposure with US & Europe Market
• Work Locon: APL Research Center I Sy.No.313&314, Bachupalli Medchal- Malkajgiri dist. Hyderabad, Telangana-500090

For US Market:

• Preparation, review and compilation of assigned ANDA/NDA [505 b(2)]/projects for filing and knowledge of eCTD, Module 2 and 3. Hands on experience in reviewing CMC documents of Solid and Liquid Oral Dosage forms.

For Europe Market:

• Competent with Europe filing wrt. Module 2&3. well versed with EU – Regulatory guidance and processes. Post Approval Variations and Compilations.

• Date: 10th December 2023 (Sunday)
• Time: 9.00 AM to 2.00 PM
• Venue: APL Research Center – 1, Sy. No: 313 & 314, Bachupally, Coco Cola Road, Hyderabad, Telangana- 500090

Contact Details:

• Interested candidates can send their profiles to SravanKumar.Bhimuni@aurobindo.com

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