Novartis Recruitment July 2020 Degree in Science/Bachelors/Masters/Ph.D. in Chemistry for Specialist, DRC (Development Regulatory Centers) @ Hyderabad, AP . Interested candidates may apply online for selection as detailed below.
Important Vacancy details:
- Post Name: Specialist, DRC (Development Regulatory Centers)
- Education : Degree in Science/Bachelors/Masters/Ph.D. in Chemistry
- Location: Hyderabad, AP
- Salary : NA
- Openings :NA
Job Description: We have requirement for the post of Specialist, DRC (Development Regulatory Centers) in Novartis
Authoring/responsible for preparation of regulatory submissions (e.g. ANDS, ANDA, SANDS) with support and guidance, applying agreed global regulatory strategies, assuring technical congruency, and regulatory compliance, meeting agreed upon timelines and requirements throughout project life cycle.
• Identify the required documentation for global submissions and communicate expected delivery dates of technical source documents in accordance with project timelines given by project management and SDC departments.
• Prepare query responses to health authority questions during development and registration in close collaboration with relevant SDC departments. Identify and escalate as appropriate content, quality and/or issues with source documents, or any other potential authorizing issues that may impact submission quality or timelines, as early as possible.
• Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends. Active participation as a member of development team by contributing to the regulatory strategy, identifying critical issues and applying lessons learned.
• Establish and maintain sound working relationship with all Sandoz Regulatory affairs departments and as well SDC teams. Interact with cross-functional teams in SDC, India for assigned development projects and prepare timely query responses, as appropriate.
Selection Process: The selection will be on the basis of Interview.
How to Apply : Click here for full details and Apply Online