- Prepare, compile, review and dispatch of new registration, variations and renewals dossiers for markets (US-OTC, LATAM, JAPAC, ROW,ASEAN,ASIAN,MENA, CIS, & African) as per guidelines.
- Identify the gaps in submission components against approved submission regulatory plan.
- Review technical documents like process validation, AMV, Stability and composition etc. received from Site QA or R&D/ADL against DMF/Dossier requirement
- Request, coordinate and follow up with multiple stakeholders to arrange all components against approved submission regulatory plan for timely regulatory submissions.
- Prepare various pharmacological, pre-clinical & toxicological data based on published literature.
- Review of artworks for labeling, narrative statements and giving approvals for various countries as per marketing requirements
- Provides regulatory input for follow-up to inspections and audits to minimize potential for findings of noncompliance.
- Monitor and maintain up-to-date knowledge of national, European, and International guidelines/legislation
- To handle & timely submission of additional requirements raised by Health authorities.
- Maintain & update the database for easy retrieval of documents & information submitted with the Regulatory Agencies.
- Present and distribute department level technical knowledge, SOP & ICH guidelines training.
- Responsible to prepare GAP analysis in order to identify the key points and ensure generation and availability of data in an efficient and time bound manner.
- Keep track of the submissions until approval is received.
- Relates/contributes to the development of internal policies, process, procedures supporting the progression and maintenance of the pharmaceutical portfolio at large.
- Fosters excellent relationships across the stakeholder departments.
- Provide guidance to other team members and cross-functional groups to resolve issues related to timelines, source documents or other regulatory-related matters that could impact the timeliness or quality of submissions.
- Facilitate issues identification and resolution, problem solving, risk management, contingency planning and decision making.
- CCF Assessment as per regulatory perspective.
Job Location - North India
Interested candidates can share profile at [email protected] or can WhatsApp at 8629031243.
