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Manager, CMC (Regulatory Affairs)

Truevacancy

Last Updated: 7/23/21

Job Description

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: Nalgonda



Company Details

Hyderabad, Telangana, India
Truevacancy  is a staffing company serving since 2019. Truevacancy has been immensely successful in creating a network of highly adept intelligent workforce that can help a company achieve their mission-critical projects and goals. Keeping pace with projects and being on the look out for the extremely talented individuals has become ever more challenging. Here is where Truevacancy comes...