Executive Regulatory Affairs

To ensure that ensuring that quality standards are met and submissions according regulatory requirements.

Regular updates along with changes in regulatory legislation and guidelines.

Planning, undertaking and overseeing regulatory inspections.

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

Preparing documents for obtaining marketing permission, COPPs, FSCs and other certificate as required from the FDCA.

Compilation & review of documents for dossier submissions.

Addressing queries received on dossiers submitted for approvals.

Supervising the preparation & submission of registration samples in interaction with the production and QC department.

Filing of the office copies of dossiers, certificates and other documents filed with regulatory authorities.

Preparation of PDL upon receipt of the regulatory approval.

Perks and Benefits

Best in the Industry