Regulatory Affairs Specialist

1 month ago


Madurai, Tamil Nadu, India Aurolab Full time

Aurolab is seeking a highly skilled Regulatory Affairs Specialist to join our team in Quality Assurance. This critical role requires comprehensive knowledge of regulatory requirements, excellent organizational skills, and the ability to work collaboratively across departments to ensure compliance with all applicable regulations.

The successful candidate will be responsible for preparing, managing, and coordinating regulatory submissions for USFDA and MHRA approvals for products manufactured at our plant. This includes ensuring the plant's compliance with USFDA and MHRA regulations, guidelines, and standards.

We are looking for an experienced professional with a strong background in pharmaceutical or biotechnology industry, preferably with hands-on experience in obtaining ANDA approval. The ideal candidate will have in-depth knowledge of USFDA and MHRA regulations and guidelines.

The salary for this position is estimated to be around $120,000-$150,000 per year, depending on location and qualifications. If you are a motivated and detail-oriented individual with excellent communication skills, we encourage you to apply for this challenging and rewarding role.



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