The Trainee Regulatory Affairs will be a part of the GRACS team which supports regional CMC strategy, preparation of CMC documentation. Under the direction of the area supervisor, responsible for the planning, preparation, and release of regulatory submissions (IND/CTA, NDA/BLA/MAA, post-approval supplements, annual reports, etc.) and administration of associated GRACS-CMC systems and processes for the progression of commercial/non-commercial manufacturing change controls from initial authorization throughout the project s lifecycle in the Planning, Dossier Management, Manufacturing Change Control, and Health Registration Management Systems support to ensure right at first-time submissions.
The primary activities include but are not limited to the following:
- Supports CMC regulatory strategies for post-approval changes.
- Supports regulatory change control assessment identifying regulatory requirements for CMC submissions.
- Review documentation to support submission according to regulatory requirements.
- Assists timely responses to Health Authority questions resulting from post-approval submissions and ensures compliance against regulatory requirements.
- Attends cross-functional meetings providing input on CMC requirements.
- Supports product compliance by ensuring registrations and lifecycle management align with product manufacturing details.
- Provides input on continuous process improvement activities within the organization and participate in forums to ensure efficient processes and best practice.
- Ensures awareness of regulatory policy trends.
- Identifies, communicates and escalates potential regulatory issues management, as needed.
- Utilize GRACS and/or our Manufacturing Division systems to progress and track activities related to Change Control, Dossier planning and content management, and Health Registration Management
- Update regulatory tools and databases on a routine schedule following the guidance of the CMC scientist to ensure timely delivery of assigned activities.
- Assist in the development and continuous improvement of business processes, tools, systems, metrics, and analytics under the supervision of the manager.
- Provide support for other CMC projects and activities as needed.
Qualification:
M. Pharm Fresher (Pharmaceutics/ Pharmaceutical Analysis/ Regulatory Affairs)
Must be proficient in English; additional language skills are a plus.
