Job Description

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Manager - International Operations Regulatory Affairs - OCE
Category: Reg Affairs & Safety Pharmacovigilance
Location:
Bangalore, Karnataka, IN
Department: IOSO Regulatory Affairs Bangalore
Are you a visionary leader passionate about making an impact? Do you strive to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you ready to lead and inspire a high-performing team? If so, raise your hand because an exciting leadership opportunity awaits you as Manager - International Operations Regulatory Affairs - OCE with us. Apply Now - At Novo Nordisk, we assure you will experience the best.
The Position
Novo Nordisk is seeking a dynamic and experienced Regulatory Manager to lead our IORA OCE team, playing a pivotal role in driving business performance and ensuring regulatory excellence. This leadership position involves overseeing team performance and ensuring the quality of regulatory outputs across key markets. The OCE team delivers comprehensive regulatory support for NDA and LCM applications, post-approval changes, and Q&A, including interactions with local Health Authorities.
Key Responsibilities:

• Strategic Leadership: Provide leadership and strategic direction to the team. Formulate and execute regulatory strategies that align with overarching IO regulatory objectives while fostering the growth and expansion of IORA OCEs.
• People & Resource Management: Inspire, mentor, and cultivate a high-performing team. Lead efforts in recruitment, performance management, and fostering a culture of engagement and development.
• Business & Operational Performance: Ensure the seamless execution of regulatory processes. Optimize workflows to enhance efficiency and continuously drive improvements in regulatory operations.
• Quality, Compliance & EHS: Uphold compliance with the Quality Management System (QMS) and adhere to all internal and external regulatory standards. Foster a safe and healthy working environment for all employees.
• Stakeholder Collaboration: Develop and maintain strong relationships with global, regional, and affiliate regulatory teams. Ensure effective communication and cross-functional collaboration to achieve regulatory success.
• Innovation & Process Optimization: Lead innovation by identifying opportunities for efficiency and implementing best practices. Identify white spaces for centralization, strive to eliminate process bottlenecks and accelerate submission and approval timelines.

Qualifications

• Graduate/Postgraduate in Science, Pharmacy, Medicine, or a relevant field.
• 8+ years in Regulatory Affairs or relevant functions and minimum 3 years of leadership experience managing teams in a regulatory or compliance-driven environment.
• Knowledge of Regulatory Global processes, International & commercial Regulatory frameworks & intelligence, including country specific NDAs/LCMs rollouts.
• Proficiency in Regulatory Systems including Veeva Vault RIM and Compliance Standards.
• Strong understanding of the Drug Development Process & R&D Value Chain.
• Expertise in Project Management for regulatory initiatives.
• Business & Commercial Acumen to align regulatory strategy with commercial goals.

About the department
The International Operations Strategic Operations Regulatory Affairs - Bangalore (IOSO RA Bangalore) is a critical extension of the global IOSO RA (Zurich & Copenhagen) organisation & will together deliver on the function's aspiration to enable fast growth, portfolio integration & business continuity at scale. The team consist of high calibre regulatory professionals offering core regulatory & project management capabilities enabling NN secure fast, high quality product approvals across International Operations.
Working at Novo Nordisk
Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 72,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us! Together, we go further. Together, we're life changing.
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: 25th March 2025.
Disclaimer
It has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process.
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.