Manager, CMC (Regulatory Affairs) (TR370022021)

Dear Job Seekers,

Novartis is Hiring for:

Job Title: Manager, CMC (Regulatory Affairs)

Job Description:

• Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate with management as appropriate.
• Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans.
• Minimum requirements What You will bring to the role: University or College Degree in any field or life science with relevant industry experience or comparable degree.
• At a minimum 7 years’ experience in the Pharmaceutical area, specifically in Regulatory Operations
• Good communication in English (oral and written).
• Knowledge of Regulatory guidelines for the areas mentioned above Organizational awareness and experience working cross-functionally and in global teams is a plus
• Ability to work under pressure, demonstrating initiative and flexibility Attention to detail and quality focused

Experience: 7 years

Salary: As per the Company Standards

Location: Hyderabad