Regulatory Affairs job vacancy at Mumbai in Meridian Enterprises

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 / R&D 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 3 years of experience in regulatory affairs or in pharmaceutical formulation.