Executive / Officer /Sr. Officer - Regulatory Affairs

Role & responsibilities

Preparation of Dossiers

• Co-ordination with different departments for getting required data for compilation of variation package.
•  To upload documents in National portal for respective European regulatory Agency.
•  Preparation of approval Packages based on initial approval and update of approval package based on
• query responses, variations and renewals.
•  Having on hand experience in Europe customers extension projects.
• Compiling and preparing of the CTD/ ACTD/ ECTD dossiers for regulatory and semi-regulatory markets.
• Preparation and Submission of Variation Package from module 1 to module 3 in eCTD format for Europe market
• Coordinating with the Plant and Purchase department for relevant documents.
• Reviewing of the relevant documents.
• Coordinating with CMO partners for relevant modules of the dossiers.

Artwork

• Reviewing Artwork labels.
• Updating and modifying the artwork with country specific requirements.
• Coordinating for translations, if needed.

Handling queries

• Responding to queries from the Health authorities.
• Handling variation for existing registrations or MAs.

Preferred candidate profile

Exposure of EU Market

Perks and benefits

As per Candidature

Interested Candidate may apply on :

gita.hr@vsinternational.co.in