Sr. Executive - RA (Formulations)

Department -

Role & responsibilities

• Preparation of successful pharmaceutical license application to Global Regulatory agencies.
• Reviewing regulatory documents such as manufacturing batch records, packaging batch records, analytical method, validation protocol and reports, stability protocol and record cards.
• Responsible for co-coordinating with cross-departmental teams such as Contract Lab and Contract Manufacturer for timely submission if required, collection of documents, review of documents and resolving any regulatory discrepancies.
• Responsible for compiling regulatory documents including Quality Module of Dossier for Global market as per regional requirements(s).
• Responsible for review of regulatory documents including Quality Module of Dossier for Global market as per regional requirements(s).
• Preparation of dossier due-diligence report and identify timelines for all new projects that have been identified extended to other market for approved EU products.
• Compilation and review of deficiency or RFI received from regulatory agencies or customer/partner for timely approval of medicinal products.
• Keeping up to date with regulatory issues in drug development processes and working to eliminate or minimise regulatory barriers.
• Providing training to new recruits and guide them through to understand the procedure well.
• Keeping up to date mail communication with customer/partner and MOH regarding queries.
• Compile, Review and upload dossier sections in the eCTD software, as per submission requirements.
• Proactively keeping up to date with Regulatory guidance.
• Maintenance of database with regulatory submission and approval.

Preferred candidate profile

• M.Pharm Graduate
• 4- 7 Years Exp. in RA, exposure to Europe, UK & US market.
• Experience in Formulations are preferred.
• Local Candidates from Vadodara are preferred.