Job Description

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Associate Regulatory Professional I
Category: Reg Affairs & Safety Pharmacovigilance
Location:
Bangalore, Karnataka, IN
Department: IOSO Regulatory Affairs - OCE
Are you passionate about regulatory compliance and ensuring the safety of medicines? Do you want to be part of a team that shapes future regulatory frameworks? We are looking for an Associate Regulatory Professional I to join our IOSO Regulatory Affairs - OCE team. If you are ready to make a difference in the world of healthcare, read more and apply today for a life-changing career.
The position
As an Associate Regulatory Professional I, you will:

• Extend support on the compiling, submission, and approval of Country Specific Submissions files for the responsible countries (NDA, LCM & post approval changes).
• Support affiliates in updating local requirements based on regulatory agencies guidance and input from affiliates/distributors.
• Manage working relationships with key stakeholders.
• Ensure compliance with regulatory requirements and provide strategic product direction to teams.
• Interact and negotiate with regulatory agency personnel to expedite approval of pending registrations and respond to any questions.
• Serve as a regulatory liaison on the project team throughout the product lifecycle and ensure regulatory impact assessments of production and label changes.

Qualifications
To be successful in this role, you should have:

• Minimum 2+ years of experience in Regulatory Affairs or a related function within the pharmaceutical industry
• Master's degree in science, Pharmacy, Medicine, or a relevant field.
• Regulatory Affairs Expertise
• Intermediate knowledge of pharmaceutical regulatory frameworks and industry landscape.
• Familiarity with global and regional regulatory guidelines and compliance requirements.
• Understanding of Regulatory IT systems and tools used in submission and compliance processes.
• Cross-functional business understanding within Regulatory Affairs and related domains.

About the department
You will be joining the IOSO Regulatory Affairs - OCE team, a dynamic group dedicated to ensuring regulatory compliance for new products and product amendments. Our team is responsible for gaining regulatory approval for clinical trial applications, new drugs, devices, and digital health, as well as expanding the availability of existing products. Located at our headquarters, our department fosters a collaborative and fast-paced atmosphere where you can make a real impact.
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 recognise 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: 14th April 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.