Regulatory Specialist - GRL

Location

Bangalore | India

Job description

Department: RA Rare Endocrine Disorders

Are you passionate about ensuring regulatory compliance for early phase products and/or managing product life cycle and amendments? Do you want to play a crucial role in keeping patients safe and ensuring Novo Nordisk’s license to operate by supporting in creating regulatory strategies?

We are looking for a skilled colleague who will be instrumental in creating regulatory strategies in the most efficient way.

If you are detail-oriented, have strong communication skills, and are ready for a challenging and rewarding career, read on and apply today for a life-changing opportunity.

The Position

As a Regulatory Specialist at Novo Nordisk, you will have the following responsibilities:

• Regulatory Submissions: Plan and execute all regulatory submissions worldwide, including strategy development, document creation, file preparation, publishing, distribution, and response to health authorities.
• Regulatory Interactions: Plan and conduct interactions with health authorities, including meeting preparation, rehearsal, and minute-taking.
• Core Labeling: Develop and maintain core labeling, ensuring alignment with business opportunities and regulatory requirements throughout the product lifecycle
• Global Regulatory Lead: Assume leadership for early development projects (G0 to G2), developing regulatory strategies in line with NN Global Project Framework. Serve as the Regulatory Affairs representative in the Project Core Team and Global Project Team, leading and managing all regulatory activities and ensuring alignment with project objectives.
• Serve as the Regulatory Affairs representative in the Global Project Team (GPT)

Qualifications

To be successful in this role, we are looking for candidates with the following qualifications:

• Preferred Master of Science (life sciences) relevant experience and/or PhD with 12+ years of relevant regulatory experience
• In-depth knowledge of regulatory science and requirements in multiple regions including EU, US, China, Japan, and others.
• First-hand experience in life cycle management, label development, health authority interactions, and device development.
• High proficiency in regulatory intelligence and therapeutic area knowledge.
• Demonstrated project management skills.
• Understanding of business management and the R&D value chain in the pharmaceutical industry.
• Familiarity with digital health, competitive intelligence, disease understanding, statistics, pharmacovigilance, non-clinical and clinical pharmacology.
• Knowledge of patient access, real-world evidence, and proficiency in written and spoken English.

About the department

The Regulatory Affairs department plays a vital role in ensuring the compliance of Novo Nordisk’s medicines and devices. Our team works closely with regulatory authorities and internal stakeholders to navigate the complex regulatory landscape and bring innovative products to market. We value diversity and expertise, creating a collaborative and multi-disciplinary environment where professionals from various backgrounds come together to make a difference. Join us and be part of a team that is dedicated to improving patient lives.

Working At Novo Nordisk

At Novo Nordisk, we are driving change to defeat diabetes and other serious chronic conditions. Our treatments today are benefiting millions of people living with diabetes, obesity, and rare blood and endocrine diseases. From our labs to our factory floors, we are discovering and developing innovative biological medicines and making them accessible to patients throughout the world. Since the company was founded in Denmark more than 100 years ago, we have been translating the unmet medical needs of people living with serious chronic diseases into innovative medicines and delivery. Our focus is on these diseases, which affect hundreds of millions of people and are among the most urgent global health challenges. By combining our innovation and commercial excellence, we draw upon insights from patients and partners to transform bold ideas into life-saving and preventive medicines. Our ambition is to take the lead in each of these areas, driving change with an unfailing belief that it can be done.

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: 22nd March 2024

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.

Job tags

Salary