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Manager - International Operations Regulatory Affairs - Oce

8+ years
Not Disclosed
10 March 19, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Manager – International Operations Regulatory Affairs - OCE
Company: Novo Nordisk
Location: Bangalore, India
Job Category: Regulatory Affairs & Safety Pharmacovigilance


Are You Ready to Lead?

At Novo Nordisk, we are looking for a visionary leader with a passion for making an impact in the healthcare industry. If you’re someone who thrives on driving efficiency, innovation, and excellence, this could be the leadership opportunity you’ve been waiting for. As the Manager – International Operations Regulatory Affairs (IORA) - OCE, you will lead and inspire a high-performing team while ensuring regulatory excellence across key markets.


Position Overview:

As a Regulatory Manager, you will play a pivotal role in driving business performance and leading the IORA OCE team. This leadership role involves overseeing team performance, ensuring regulatory quality across markets, and managing comprehensive support for NDA, LCM applications, post-approval changes, and Q&A interactions with local Health Authorities.


Key Responsibilities:

  • Strategic Leadership: Provide clear direction and formulate regulatory strategies that align with international objectives while fostering team growth and operational success.

  • People & Resource Management: Lead, mentor, and develop a high-performing team. Oversee recruitment, performance management, and foster a culture of engagement and development.

  • Business & Operational Performance: Ensure seamless execution of regulatory processes, enhancing workflows and driving continuous improvements.

  • Quality, Compliance & EHS: Uphold strict compliance with internal and external regulatory standards, ensuring a safe and healthy working environment.

  • Stakeholder Collaboration: Build strong relationships with global, regional, and affiliate regulatory teams to ensure effective communication and successful regulatory outcomes.

  • Innovation & Process Optimization: Lead the identification of efficiency opportunities, centralize processes where possible, and eliminate bottlenecks to accelerate submission and approval timelines.


Qualifications:

  • Educational Background: Graduate/Postgraduate in Science, Pharmacy, Medicine, or a relevant field.
  • Experience: 8+ years in Regulatory Affairs or related functions with at least 3 years of leadership experience managing teams in regulatory or compliance-driven environments.
  • Skills & Knowledge:
    • Deep understanding of global regulatory processes and frameworks.
    • Proficiency in Regulatory Systems (e.g., Veeva Vault RIM).
    • Expertise in Regulatory Intelligence and country-specific regulatory requirements.
    • Strong knowledge of the Drug Development Process and R&D Value Chain.
    • Project management experience for regulatory initiatives.
    • Business and commercial acumen to align regulatory strategies with organizational goals.

About the Department:

The International Operations Strategic Operations Regulatory Affairs - Bangalore (IOSO RA Bangalore) team is a crucial part of our global IOSO RA organization. Together, we support Novo Nordisk’s aspiration to secure fast, high-quality product approvals and contribute to our business continuity and growth.


Why Novo Nordisk?

Novo Nordisk is a global leader in healthcare, with a legacy of driving change to tackle chronic diseases, especially diabetes. Our impact reaches over 40 million patients worldwide. Join us, and work with more than 63,000 employees worldwide who are dedicated to creating a healthier future. Here, your ideas and perspectives matter, and we’re committed to helping you thrive professionally and personally.


Contact:

If you believe you are a match for this role and are ready to take on this exciting opportunity, please apply through our online application tool.


Deadline:

Apply by: 21st March 2025


Disclaimer:
Be cautious of fraudulent job offers posing as Novo Nordisk representatives. We do not request fees or personal payments during the recruitment process.