Executive/Senior Executive, Regulatory Affairs
- Candidate must have minimum 5-6 years of work experience in the field of regulatory affairs covering markets like US, EU and other emerging markets.
- Candidate must be a Graduate/Post Graduate in Pharmacy or Life sciences. (In exceptional cases, the candidate with equivalent pharma work experience with non-pharma academics can be considered.)
- Candidate must have ability to determine priorities of responses when working on multiple projects.
- Candidate must have technical expertise to de-bottleneck issues related to work management / communications; escalate major issue to the seniors for speedy resolution.
- Excellent self-evaluation skills to identify training needs for further self - development.
- Candidate must have flexibility to work in different time zones to meet business needs if required.
- Must have good command over English language.
- Compile the dossier (CTD Module 1 to Module 5 or equivalent) ensuring all the relevant documents are present and complete to comply with all national requirements for submission by minimizing transcriptional errors; under guidance from seniors
- Evaluate post approval changes for eg.: variations, site transfers, MATs, renewals, PSURs and compile suitable package in consultation team leaders.
- Provide inputs for any ad-hoc questions/projects.
- Understanding of Module 1 / Administrative requirements for registrations worldwide.
- Effective coordination with seniors for project deliverables within standard timelines
- Effective coordination with PMs for completing project deliverables within stipulated timelines.
- Respond to comments and queries received from PMs and internal stake holders in consultation with seniors.
- Smooth interdepartmental partnering, collaboration, interactions and co-ordination.
- Active involvement in regulatory intelligence through various set processes and ongoing interaction with project management teams.
- Ensure relevant databases, project status files etc are up to date at all times for all activities by providing the needed information to the managers.
- Attend trainings organized for team members on dossier information, dossier compilation, deficiencies, administrative requirements specific to geographies etc.
- To understand the Pharmacovigilance requirements of key geographies like EU & US.
Note: all fields are required