Job summary
This Position is for Executive level position for Regulatory Affairs.
Roles & Responsibilities:
- Compile, prepare, review and submit regulatory dossiers & applications to authorities, mainly in India and emerging / ROW markets
- Monitor and follow-up on application status directly or through liaison agents and prepare appropriate responses to queries from regulatory authorities
- Assess the acceptability of manufacturing data, quality, preclinical & clinical documentation and compile for regulatory filing
- Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes
- Anticipate & guide on regulatory requirements & potential obstacles throughout the product lifecycle such as manufacturing process changes and updation of specifications
- Develop new regulatory policies, processes and SOPs and train key personnel on them
- Coordinate on Pharmacovigilance procedures including filling of forms, compiling investigation report & reporting to authorities
- Must function independently as a decision-maker on regulatory issues, and must assure that deadlines are met
- Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies