Job Title: Regulatory Affairs Manager
No. of Posts: 2
Salary: INR 3,00,000 – 7,00,000 P.A.
- To understand and refer the country specific regulatory requirements for product registration application.
- To obtain required data/information/document from inter-functions for dossier/query response/variation preparation.
- To review & finalize the received technical information from inter-functions to ensure regulatory compliance as per guidance & ICH guidelines.
- Preparation and submission of dossier in accordance with country specific requirement and ICH, to Partner / Authority.
- To handle regulatory queries arising from regulatory partner/authorities and respond it in committed timeframe.
- To prepare the variation application as per county specific guideline for received affected change cases.
- Preparation of Artworks for commercial / registration purpose.
- To work closely with local regulatory associates / authority for allocated projects.
- To follow IRA internal SOPs for each allocated activities and record the respective activities in defined logbooks/internal files.
- Review of APR against the approved information to finalize regulatory data in APR.
- The candidate must have
- 3 – 6 years of experience in IRA department, preferably in injectable products
- Sound knowledge of ICH guideline
- Educational Qualifications : B. Pharma / M. Pharma
- Personal Attributes and skills : The candidate should have
- Good communication and interpersonal skills,
- Ability to manage multiple responsibilities
- Attention to details and team player