Regulatory Professional II
Novo Nordisk
Bangalore, Karnataka, India
10h ago

The position

As a CMC Regulatory Professional, you will be responsible for regulatory submissions and regulatory interactions with Health Authorities (HAs) worldwide.

Your core responsibility will be to establish and maintain Chemistry Manufacturing and Controls (CMC) / Device part of regulatory file.

Defined standard CMC variation applications (e.g. Additional manufacturing site, extension of product shelf life, new cell banks) and manufacturing site submissions, follow-up and approvals.

Further you will be engage in maintaining the marketing authorization : renewals, annual reports, post approval changes, CTA / IND amendments, meeting request and meeting packages.

You will be responsible for preparation and compilation of the individual sections of all files for the defined area of responsibility, in accordance with internal requirements and external regulatory guidelines and regulations.

You will be supporting the post-approval activities. Applying intelligence and developing regulatory strategies. Creating content plan and maintaining regulatory affairs submission plans in regulatory tools / system.

You will be responsible for planning and conducting regulatory interactions with health authorities including preparation of meeting requests, meeting packages, rehearsal and taking minutes of formal meetings.

Addition to the above, you will be responsible for identifying and developing better practices and creating improvements in methods, processes and approaches related to regulatory documentation and strategies.

This position requires you to be highly self-motivated, proactive, organised and have excellent stakeholder management, communication skills.

Ensure quality of submissions by complying to procedures and systems.

Qualifications

Below are the required skills.

  • Master of Science (life sciences) and / or PhD or Bachelor (life Sciences)
  • Above 8 years of experience in pharmaceutical industry in Regulatory Affairs
  • Experience in European Union, Japan, China, Australia and Row of the World markets
  • Good communication skills
  • Communicating with HAs with scientific insight and professional authority. Competence in decision making, as well as flexibility and excellent cooperation in an international environment
  • Highly proactive and able to take initiatives
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