Job Title: Senior Manager Regulatory Affairs
Location: Islamabad, PK
Terms: Full-Time
Manager Regulatory Affairs Jobs 2021 | Novartis Careers April 2021
About Company (Novartis):
- Novartis inaugurates innovative watershed project in India to increase water availability.
Our purpose is to reimagine medicine to improve and extend people’s lives. We use innovative science and technology to address some of society’s most challenging healthcare issues. Discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.
Manager Regulatory Affairs Jobs 2021 | Novartis Careers April 2021
Job Responsibilities:
- -responsible for implementing regulatory strategy and managing operational activities for assigned medium regions.
- -Implement RFP across assigned regions.
- -Determine requirements and sets objectives for Health Authority (HA) interactions with DRA GPT representative and/or GTAL.
- -Develops and implements plans for timely response to HA requests and coordinates responses.
Requirements :
- -Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents.
- -Develops and implements plans for timely response to HA requests and coordinates responses.
- -Drives coordination, planning, and submission of dossiers in assigned regions worldwide.
- -Review of global dossier summary documents.
- -Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).
- -Reviews and submits Risk Management Plans.
- -May lead negotiations for regional approvals independently or with DRA GPT representative and/or GTAL.
- -Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the DRA GPT representative and/or GTAL.
- -Contributes to and often lead the development of departmental goals and objectives.
- Submit your application for the post of Manager Regulatory Affairs Jobs 2021 | Novartis Careers April 2021
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