Are you passionate about regulatory affairs and safety pharmacovigilance? Novo Nordisk is seeking a talented professional to join their team in Bangalore, Karnataka. This role is perfect for individuals with 6+ years of experience in Regulatory Affairs/CMC and a degree in Life Sciences, Chemistry, Pharmacy, Medicine, or Biotechnology. Read on to learn more about this exciting opportunity and how you can become a part of Novo Nordisk, a leading global healthcare company.
About Novo Nordisk
Novo Nordisk is a renowned global healthcare company with a century-long legacy of innovation and excellence. Known for its commitment to defeating serious chronic diseases, Novo Nordisk has expanded its reach to impact millions of lives worldwide. With over 63,000 employees globally, the company is dedicated to fostering an inclusive and collaborative work environment. By joining Novo Nordisk, you will be part of a team that is making a significant difference in the world.
About the Department
The Regulatory Affairs department at Novo Nordisk plays a crucial role in ensuring that all medicines and devices are developed in compliance with regulations while keeping patients' needs in mind. The department works closely with relevant authorities and internal stakeholders throughout the product development process, from New Drug Applications (NDA) to Life Cycle Management (LCM) activities. The team is diverse, bringing together professionals from various academic and professional backgrounds, which contributes to the department's high standards and dynamic work environment.
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Novo Nordisk Hiring Regulatory Affairs & Safety Pharmacovigilance Professional[/caption]
Job Role and Responsibilities
As a Regulatory Affairs & Safety Pharmacovigilance Professional, you will be responsible for:
- Making timely submissions to Health Authorities worldwide.
- Establishing and maintaining the CMC part of the core regulatory file.
- Supporting submission planning by developing regulatory strategies.
- Creating and maintaining the Regulatory Submission Plan, including document creation and review.
- Handling change requests, deviations, and responses to RSI/HA queries globally.
- Supporting NDA renewals and post-approval changes.
- Managing annual reporting and maintenance of marketing authorizations globally.
- Utilizing Veeva Vault for submission and registrations.
- Playing a key role in stakeholder management, ensuring effective communication channels to strengthen relationships.
Qualifications
To be considered for this role, candidates should meet the following qualifications:
- 6+ years of experience in Regulatory Affairs/CMC.
- Graduate or postgraduate degree in Life Sciences, Chemistry, Pharmacy, Medicine, or Biotechnology.
- Experience working in both global and affiliate environments.
- Strong understanding of end-to-end regulatory processes and life cycle management.
- Proven negotiation and project management skills.
- Proactive, self-managed, and able to handle multiple priorities.
- High cultural sensitivity and comfortable working across multiple time zones.
- Excellent written and spoken communication skills.
Working at Novo Nordisk
Working at Novo Nordisk means being part of something bigger than yourself. The company values the unique skills and perspectives of its employees and continuously strives to bring out the best in them. Novo Nordisk's collaborative and innovative work culture provides ample opportunities for professional growth and development. By joining Novo Nordisk, you will contribute to a mission that impacts millions of lives daily.
How to Apply
If you believe you are a match for this role and are eager to contribute to Novo Nordisk's mission, apply online through their official application tool. Ensure you submit your application before the deadline on July 22, 2024.
Deadline: Apply on or before July 22, 2024
https://pharmastuff.org.in/job/novo-nordisk-hiring-regulatory-affairs-safety-pharmacovigilance-professional
