Job Description

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Regulatory Manager - IORA OCE

Category: Regulatory

Location:

Bangalore, Karnataka, IN

Department: International Operations Regulatory Affairs

Are you passionate about what you are doing? Do you want to rebuild excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, raise your hand as there is an exciting opportunity waiting for you as \xe2\x80\x9cRegulatory Manager\xe2\x80\x9d with us. \xe2\x80\x9cApply now\xe2\x80\x9d - At Novo Nordisk we assure you will experience the best.

About the Department

International Operations Regulatory Affairs Bangalore in Global Regulatory Affairs Global Business Services (GBS) is a global RA hub consisting of high calibre regulatory professionals. The objective of the team is to offer core RA competencies enabling NN secure fast, high quality product approvals. The team delivers full strategic and operational support on a global scale across value chain on core regulatory processes across NN product portfolio. We provide regulatory expertise and work very closely with our colleagues in IORA in Zurich and regions, RAHQ in Denmark as well as colleagues in our affiliates all over the world. Our people have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs truly interesting and challenging to work.

The Position

As a Regulatory Manager, the ideal candidate will be responsible for the business performance of the IORA OCE. The role, being a leadership role will require candidate to be overall responsible for the performance of their team members and quality of their work. The OCE team is responsible for providing end to end regulatory support on the NDA and LCM applications, post approval changes and Q&A for the supported countries in International Operations. The candidate will be expected to leverage his/her expertise & regulatory process knowledge in finding ways to have faster submission & approval by collaborating with RAHQ, Affiliate including National Health authorities.

People development incl. 3P (Performance appraisal), job descriptions, Individual Development Plans (IDP), salary, bonus, nomination of employees for promotions, Recruitment, and resignation. The responsibilities further include leading the team in line with Novo Nordisk Way to ensure optimal employee development and resource utilisation.

• Ensuring skills and competencies of the team are aligned with the demands and requirements set by present and future projects.

• Optimise processes & strives to eliminate bottlenecks and secure an optimal utilization of resources.
• Establish healthy and safe working conditions and workplaces within own area of responsibility for both Novo Nordisk employees and non-Novo Nordisk employees.
• Communicate timely within team and department as well as to all stakeholders and ensure stakeholders understand regulatory processes and support them with trainings, knowledge sharing.
• Ensure compliance with local legal requirements and Novo Nordisk agreements related to health and safety

Qualifications

• 8+ years of work experience within Regulatory Affairs with Graduation or Postgraduation in Science / pharmacy / medicine / relevant.
• Min. 1 year of experience in managing teams / Leadership role.
• String understanding of Regulatory processes, Regulatory Intelligence & RA landscape.
• Highly proactive and able to take initiatives & manage multiple priorities.
• Self-managed, strong personal drive and ability to engage with team towards delivering excellent performance and results.
• High cultural sensitivity and comfortable working with different countries and cultures across multiple time-zones.
• Able to communicate and interact with professional authority, excellent project management skills.

Working At Novo Nordisk

At Novo Nordisk, we don\'t wait for change. We drive it. We\'re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales- we\'re all working to move the needle on patient care.

Contact

If you believe you are a match for the above requirements and are willing to take up the role, please apply here with our online application tool.

Deadline

Apply on or before: 2nd May, 2023

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we\'re life changing.

Novo Nordisk