Novo Nordisk Hiring for egulatory Affairs / Safety Pharmacovigilance
- Novo Nordisk
- Location: Bangalore, India
- Experience Required: Minimum 2 years
- Education Qualification: M.Pharm, MSc, Pharm.D, Medicine
- Application Deadline: April 3, 2025
- Employment Type: Full-Time
- Application Mode: Online
Job Overview Novo Nordisk Hiring for egulatory Affairs
Are you passionate about regulatory compliance and drug safety? Join Novo Nordisk’s IOSO Regulatory Affairs – OCE team as an Associate Regulatory Professional I and be part of a global leader in the pharmaceutical industry. This role provides an excellent opportunity to engage in regulatory affairs and safety pharmacovigilance, ensuring that our pharmaceutical products meet global and regional compliance standards. Novo Nordisk Hiring for egulatory Affairs
If you have a strong background in regulatory affairs and a keen interest in shaping future pharmaceutical regulations, we invite you to apply for this life-changing career opportunity!
Key Responsibilities Novo Nordisk Hiring for egulatory Affairs
As an Associate Regulatory Professional I, you will play a critical role in regulatory compliance by managing submissions and ensuring adherence to evolving regulatory requirements. Your primary responsibilities will include: Novo Nordisk Hiring for egulatory Affairs
Regulatory Submissions & Compliance
- Compile, submit, and manage Country-Specific Submission (CSS) files, including New Drug Applications (NDA), Lifecycle Management (LCM), and post-approval changes for assigned regions.
- Support regional affiliates in updating local regulatory requirements based on changes in agency guidelines and distributor inputs.
- Ensure that all submissions comply with global and regional regulatory standards.
Stakeholder & Agency Interaction
- Establish and maintain strong relationships with internal and external stakeholders to ensure smooth regulatory processes.
- Interact with global and regional regulatory agencies to facilitate expedited approvals and address queries efficiently.
- Provide regulatory guidance to internal teams on product lifecycle management, including impact assessments for production and labeling changes.
Regulatory Strategy & IT Systems
- Maintain an intermediate knowledge of global and regional pharmaceutical regulatory frameworks, such as:
- FDA (Food and Drug Administration)
- EMA (European Medicines Agency)
- CDSCO (Central Drugs Standard Control Organization – India)
- Utilize Regulatory IT systems, including:
- Veeva Vault (Regulatory Information Management System)
- Document Management Systems (DMS)
- eCTD (Electronic Common Technical Document) submissions
Qualifications & Skills Novo Nordisk Hiring for egulatory Affairs
To excel in this role, you should meet the following qualifications:
Educational Requirements:
- A Master’s degree in Science, Pharmacy, Medicine, or a related field.
Experience Requirements:
- A minimum of 2+ years of experience in Regulatory Affairs or a related function within the pharmaceutical industry.
Regulatory Expertise:
- Strong understanding of regulatory submission processes.
- Familiarity with global and regional regulatory guidelines.
- Experience in working with regulatory IT systems.
Soft Skills:
- Excellent communication and interpersonal skills.
- Strong stakeholder management and collaboration abilities.
- Strategic thinking with attention to detail.
About the Department: IOSO Regulatory Affairs – OCE
The IOSO Regulatory Affairs – OCE team is responsible for ensuring regulatory compliance across multiple regions for new drugs, medical devices, and digital health products. The team plays a crucial role in: Novo Nordisk Hiring for egulatory Affairs
- Clinical trial applications.
- New drug approvals.
- Post-approval regulatory changes and lifecycle management.
- Expanding product availability in global markets.
Located in Bangalore, India, our team operates in a collaborative and fast-paced environment where professionals have the opportunity to drive significant impact in the pharmaceutical and healthcare industry. Novo Nordisk Hiring for egulatory Affairs
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Why Join Novo Nordisk?
At Novo Nordisk, we believe in empowering our employees with the right opportunities and a balanced work environment. Here’s what you can expect when you join our team:
- Work/Life Balance: Flexible working conditions to support your professional and personal commitments.
- Challenging Projects: Opportunity to work on innovative and high-impact pharmaceutical regulatory affairs projects.
- Career Growth: Exposure to international regulatory frameworks and best practices.
- Comprehensive Insurance & Benefits: Ensuring employee well-being through extensive health coverage and perks.
How to Apply?
Interested candidates can apply online through the official Novo Nordisk careers page.