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Senior Regulatory Professional

9 - 12 years

11 - 14 Lacs

Bengaluru

Posted:2 months ago| Platform: Naukri logo

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Skills Required

Regulatory affairs life cycle management stakeholder management cmc professional development Veeva vault

Work Mode

Work from Office

Job Type

Full Time

Job Description

About the department Regulatory Affairs CMC play an important role in ensuring that all new Novo Nordisk treatments and devices are developed with compliance and the patients in mind. Liaising between relevant authorities and Novo Nordisk stakeholders, Regulatory Affairs CMC are involved throughout all phases of product development and roll-out. Our people in Regulatory Affairs come from many different academic and professional backgrounds, bringing valuable insights and expertise to the team and the company to ensure minimum time to market. This makes Regulatory Affairs a truly multi-disciplinary place to work with high professional standards, excellent opportunities for fast-paced professional development and career opportunities. The Position As a Senior Regulatory Professional, the candidate will be responsible for providing strategic input to RA CMC activities. One should have demonstrated ability to identify better practice and create improvements in methods, techniques, approaches etc. The professional will be required to handle most situations independently but will seek advice and guidance on complex issues. Further responsibilities include handling the change requests, query responses and provide strategic input at various forum representing RA CMC. Support preparation and submission of regulatory files, response to questions from health authorities and maintenance of marketing authorization globally. Negotiate with the regional affiliates on HA requirements and timelines. Manage stakeholders from across the organization including product supply. Hands on experience with Veeva vault and RIMS. The candidate will play a key role in stakeholder management and will be responsible for ensuring appropriate use of communication channels to strengthen relationships with the stakeholders. Experience 9+ years of experience within Regulatory affairs CMC with Graduate / Postgraduate degree in science/ pharmacy/ medicine etc. Experience of working in a Biologics company is preferred. Good understanding of end to end regulatory processes and life cycle management. Strategic mindset with proven negotiation skills. Should be able to convince and put forward the facts confidently. Highly proactive and able to take initiatives & manage multiple priorities. Self-managed, strong personal drive and ability to engage with colleagues and peers towards delivering excellent performance and results. High cultural sensitivity and comfortable working with different countries and cultures across multiple time-zones. Excellent written/spoken communication skills.

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Novo Nordisk
Novo Nordisk
www.novonordisk.com

Pharmaceutical Manufacturing

Bagsværd Kalundborg

10001 Employees

202 Jobs

    Key People

  • Lars Fruergaard Jørgensen

    President and CEO

  • Jakob Riis

    Executive Vice President, Commercial Strategy & Corporate Affairs

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