Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : DRC Specialist
1. 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.
2. Prepare query responses to health authority questions during development and registration in close collaboration with relevant SDC departments.
3. 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.
4. 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.
5. Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
6. Active participation as a member of development team by contributing to the regulatory strategy, identifying critical issues and applying lessons learned.
7. Establish and maintain sound working relationship with all Sandoz Regulatory affairs departments and as well SDC teams.
8. Support to DRC manager for global regulatory strategy for developments projects with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance.
9. Interact with cross-functional teams in SDC, India for assigned development projects and prepare timely query responses, as appropriate.
10. Assume specialized assignments as assigned and represent own departments in cross-functional project teams.
11. Other tasks as assigned by the supervisor, and tasks based on a specific appointment
12. Other tasks determined during the annual objectives setting process and by KPIs
13. Implementation of and compliance with all the instructions and requirements for safety at work, environment protection, and property protection
1. Master’s Degree in Science or Pharmacy with Minimum 5 years to 8 years of relevant experience in Regulatory Affairs
2. Knowledge of ICH, EMA, US FDA guidelines and regulatory procedures
3. Ability to plan and priorities workload
4. Ability to work in a matrix environment
5. Ability to build effective relationships across teams
6. Active command in English with excellent written and spoken communication skills
7. Good knowledge of Regulatory tools.
8. Adequate knowledge of software and computer tools.
9. Creative thinking and effective interdisciplinary collaboration with other functions.
Experience : 5+ year
Qualification : M.Sc or M.Pharm
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Research & Development
End Date : 25th July, 2019
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