Obtaining marketing permission, COPPs, FSCs and other certificate as required from the FDCA.
Gathering, evaluating, organizing, managing and information in a variety of formats as per country specific requirements for dossier submissions.
Liaison with regulatory authorities.
To provide advice about regulations to the technical staff of the company.
To provide guidance to the regulatory staff on dossier compilation and addressing of queries during registration.
Review and approve the documents submitted by vendors (DMF, Specifications, COAs etc) required for dossier submission.
Outlining regulatory requirements for manufacturing, labeling, storage and packaging studying scientific and legal documents.
Review and approve the PDL for ensuring that the products manufactured, process and formula used, packing materials used are as per the regulatory submissions.
To work in interaction with the QA team for internal audits, handling of market recalls, customer complaints (if required), compliance of regulatory audit findings.
Required Candidate profile
Key responsibilities of RA Executive/Officer
Perks and BenefitsBest in the Industry
Desired Candidate Profile
UG:B.Pharma - Pharmacy, B.Sc - Any Specialization
PG:Post Graduation Not Required, M.Pharma - Pharmacy
Baroque Pharmaceuticals Pvt Ltd
Recruiter Name:Kalpit Darji
Contact Company:Baroque Pharmaceuticals Pvt Ltd
Address :NH No. 8, At. Vaghasi, Tal & Dist. Anand, ANAND, Gujarat - 388320,India