Regulatory Professional I

7-9 years
a month ago 1 Applied
Job Description

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 supporting regulatory processes 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 Professional I at Novo Nordisk, you will be involved in:

  • Supporting and providing input to all regulatory submissions to Health Authorities worldwide
    • Submission Planning: Develop regulatory strategy, create and maintain Regulatory Affairs Submission Plan (RASP) in RA PLANiT, and review documents.
    • Regulatory File Preparation: Prepare regulatory files, publish, and distribute them as required.
    • Submission Management: Handle submissions to Health Authorities worldwide, including MAA/NDA/BLA, CTA/IND, PIP/PSP, pharmacovigilance documents, renewals, and post-approval changes.
  • Supporting and providing input to regulatory interactions with Health Authorities
    • Support Regulatory Interactions: Assist in planning and conducting interactions with Health Authorities, including preparing meeting requests, packages, and taking meeting minutes.
  • Establish and maintain core labelling.
    • Core Labeling: Provide input for the development of text for core labeling, including tCCDS/CCDS and European labeling, and support US labeling development. Assist in label development and maintenance throughout the product lifecycle.

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 7+ years of relevant regulatory experience
  • Strong understanding of regulatory science and requirements in various regions including EU, US, China, Japan, and others.
  • Experience in life cycle management, label development, health authority interactions, and device development.
  • Proficiency in regulatory intelligence.
  • 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 and real-world evidence.

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

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 63,000 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: 19th April 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.

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About
Job Source: www.novonordisk.com

Novo Nordisk A/S is a Danish multinational pharmaceutical company headquartered in Bagsv&#230&#x3B;rd, Denmark, with production facilities in eight countries, and affiliates or offices in 5 countries. Novo Nordisk is controlled by majority shareholder Novo Holdings A/S which holds approximately 25% of its shares and a supermajority (45%) of its voting shares.

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