Regulatory Affairs Executive GSS Pharma Pvt.ltd

1.0 - 3.0 years

3 - 5 Lacs

Bengaluru, Whitefield

Work from Office

We are seeking a Regulatory Affairs Executive with 1 to 3 years of experience in the pharmaceutical industry. The ideal candidate should have hands-on experience in compiling and reviewing ACTD and CTD dossiers for various regulatory submissions. Responsibilities include preparing, compiling, and maintaining regulatory documentation in accordance with regional requirements, coordinating with cross-functional teams to gather necessary data, and ensuring timely submission of dossiers. The candidate should be well-versed with regulatory guidelines, and capable of handling multiple projects simultaneously.

Posted 1 month ago

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RA Executive Meridian Enterprises

2.0 - 7.0 years

1 - 5 Lacs

Mumbai

Work from Office

Will be responsible for Dossier preparation, review submission in ACTD/CTD/Country Specific format for Product registration. Review technical documents like process validation, AMV, Stability and composition etc, labeling, batch records, specification sheets. Co-ordinate with Plant / ADL / RD for documents samples. Co-ordination with API / PM vendors to resolve technical queries w.r.t. regulatory requirements. Assisting Export Manager in marketing business development activities. Candidate Criteria: Bachelor s degree in Pharmacy or other Life Science with excellent communication skills in English. Minimum 2 years of experience in regulatory affairs or in pharmaceutical formulation.

Posted 1 month ago

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