Responsibilities

The Regulatory Associate Executive will perform the following duties:

1. Understand all applicable regulations well and implement during the tasks assigned
2. Ensure that the regulatory filing for clients are done in compliance with the regulations
3. Keep up to date with national and international legislation, guidelines, and customer practices
4. collect, collate, and evaluate scientific data from a range of sources.
5. Develop and write clear arguments and explanations for new product licences and licence renewals
6. Prepare submissions of licence variations and renewals to strict deadlines
7. Monitor and set timelines for licence variations and renewal approvals
8. Work with applicable computer software and resources
9. Write clear letters and undertaking for the clients as per specific submissions
10. Review product labels and Patient information leaflets
11. Support clients with regulatory requirements
12. Work with Project Teams to accomplish regulatory submissions
13. Face and support in regulatory inspections
14. Handle any other regulatory affairs related tasks assigned by the management from time to time.

Non-Project related duties:

1. Prepare SOPs
2. Prepare training materials.
3. Interface with clients, sites and investigators when required.
4. Participate in business meetings and make presentations when required.
5. Accomplish jobs assigned from time to time to meet satisfaction of the management
6. Work in alignment with the company objectives and common goal of the company
7.