Pharma & Chemistry Regulatory Coordinator Job Opening @ Novartis

Pharma & Chemistry Regulatory Coordinator Job Opening @ Novartis

Pharmaceutical Science Specialist. Applications are invited for the post of Regulatory Coordinator @ Novartis.Career @ Novartis. Pharma job opportunity at Novartis. Regulatory Coordinator vacancy. Interested candidates may apply online. Check out all the details on the same below:

Job Id: 266050BR

Job Title: Regulatory Coordinator

Eligibility: Masters Degree in Science or Pharmacy

Experience: Minimum 3 years to 5 years of relevant experience in publishing/Regulatory Operations

Skills:

  • Ability to plan and priorities workload
  • Ability to work in a matrix environment
  • Ability to build effective relationships across teams
  • Active command in English with excellent written and spoken communication skills
  • Good knowledge of Regulatory tools.
  • Adequate knowledge of software and computer tools.
  • Creative thinking and effective interdisciplinary collaboration with other functions.

Job Description

Your responsibilities:

Your responsibilities include, but are not limited to:

•The Regulatory Coordinator is responsible for providing operational regulatory and compliance support to the DRA global program team representative and/or GTAL on development projects/major line extensions through development, registration, and approval including post approval commitments.

•Support regulatory compliance activities, including entering product specific attributes as provided by program team representative into compliance database (DRAGON).

• Subject Matter Expert for regulatory compliance activities and supporting tools

(eg DRAGON) providing support to DRA PIE in a matrix reporting environment to ensure HQ and CPO compliance with internal procedures governing health registration management, compliance reporting and HA commitment data management activities.

•Provide support as needed for Routine Health Authority submissions including Annual Reports, New Protocol Submissions, Protocol Amendment Submissions, etc. and act as main liaison with DRA Operations to ensure accurate and timely submissions to HAs.

•Facilitate the timely delivery of sections to compile the IND/IMPD (CTAs) and NDA/MAA/CTD for Health Authority submissions

•Provide operational support for obtaining up-to-date Regulatory Intelligence and other regulatory support Information Review Support the GPRD/GPRMs to ensure: Timely delivery of Safety Labeling change submissions Timely delivery of Routine Health Authority submissions Timely completion of Drug Shipping Process (US).

•Provide support for DRA responsible part of Pharmacogilence compliance Timely completion of Module #1 in the CTD Timely completion of briefing books for regulatory Health Authority meetings Timely delivery of IND/IMPD and NDA/MAA/CTD to Health Authorities Regulatory deliverables met (i.e. power-point presentations, excel spreadsheets, informal tracking for deliverables) Timely delivery of Regulatory Intelligence and other regulatory support information Completion of submissions to Health Authority

Apply Online

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