Novartis

Novartis is hiring an International Program Regulatory Director IPRD in Hyderabad. Apply if you have exp in global/regional regulatory roles and expertise in drug registration strategies.

Join Novartis as a Regulatory Writer and contribute to high-quality clinical and safety documents supporting global drug submissions. Ideal for candidates with medical writing experience.

Lead the development and execution of local medical strategies aligned with global and franchise objectives. Identify strategic drivers and shape the patient journey and stakeholder engagement plans.

Support a discipline and or provide a service individually or within a team of associates. May provide functional expertise to Line Unit and other QA Units in area of responsibility

Understanding of drug development processes and proficiency in quality principles driving drug development such as GMP and applicable regulations and policies.

Responsible for the quality of the multichannel digital content delivered to customers. Partner with all teams to understand and implement systemic controls wherever possible, across the software supply chain, from design till release. Explore and adopt quality improvement tools or methodologies.

MSc, PhD, PharmD, or MD. experience in medical communications. Medical writing experience. Demonstrate a command of assigned therapeutic areas and expertise with assigned products.

Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system.

Support Analytical project leader for setting analytical development strategy. Support in data interpretation, results compilations and sharing the information with critical observations and proposals to project team.