5 - 8 years
7 - 15 Lacs
Posted:1 month ago|
Platform:
Work from Office
Full Time
Reporting to Sr. Director - Regulatory Affairs Experience required: 5-8 Years Education: B. Pharm / M. Pharm Department: Regulatory Affairs Key Responsibilities: Prepare the status of all documents related to submission. Compile and review Regulatory submission documents required in line with the relevant guidelines. Coordinate with all stakeholders of the manufacturing plant for the collection of documents. Evaluation of change control: evaluate all post-approval changes. Review of specifications (API, Intermediate, FP, and Shelf life) executed BMRs, BPRs, COA, Method transfer report, Method verification, Analytical chromatograms intended for regulated or non-regulated market submission. General Review of plant Site Master File, layouts, and valid GMP Compliance Certificate for its adequacy to support regulatory submission. Effectively implement post-approval commitment. Preferred candidate profile Review of CMC (Chemistry, Manufacturing, and Controls) Documents Self-motivated, detail-oriented, and highly organized professional Proven ability to collaborate and communicate effectively with diverse teams Proficient in Microsoft Word, Excel, and PowerPoint Fluent in English, with strong skills in speaking, comprehension, reading, and writing. Strong technical expertise in reviewing manufacturing site documentation.
Althera Laboratories India Pvt Ltd, Bangaore
Upload Resume
Drag or click to upload
Your data is secure with us, protected by advanced encryption.
Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.
We have sent an OTP to your contact. Please enter it below to verify.
Instantly access job listings, apply easily, and track applications.
7.0 - 15.0 Lacs P.A.
Pune
20.0 - 30.0 Lacs P.A.
6.0 - 10.0 Lacs P.A.
8.0 - 9.0 Lacs P.A.
6.0 - 10.0 Lacs P.A.
Bengaluru
11.0 - 16.0 Lacs P.A.
Rangpo
Experience: Not specified
2.0 - 3.0 Lacs P.A.
16.0 - 20.0 Lacs P.A.
7.0 - 8.0 Lacs P.A.
Bengaluru
4.0 - 8.0 Lacs P.A.
