Regulatory Affairs Lead

Regulatory Affairs Lead
Category: Reg Affairs & Safety Pharmacovigilance
Location:

Kfar Saba, Israel, IL

Are you passionate about driving regulatory strategy,life cycle management of product portfolio and ensuring interactions with regulatory authorities? Do you thrive in a multi-disciplinary environment requiring a unique combination of scientific insights and ability to navigate tight deadlines and many stakeholders?

We are looking for a Regulatory Affairs Lead to join our Regulatory Affairs team at Novo Nordisk Israel. Be part of our life-changing careers and apply today!

The Position

As a Regulatory Affairs Lead, you will be responsible for the oversight of implementing all internal and external regulatory requirements acroos our portfolio, ensuring Novo Nordisk (NN) Israel compliance with the Israeli regulations and global NN SOPs. In addition you will be managing the NN Israel regulatory team to meet NN requirements and timelines.

You will also be responsible for:

Obtaining and maintaining licences for pharmaceutical products and medical devices for NN Israel, ensuring regultory submissions of registrations, variations and renewal files according to MOH requirements and timelines and in accordance and alignment with the business needs.
Taking part in the review and approval process of marketing materials
Keeping up-to-date with regulatory guidelines and industry trends.
Collaboration with global cross-functional teams and with stakeholders from NN affiliates worldwide ranging from safety issues, medical affairsand commercial activities, to ensure compliance with regulatory requirements.

Qualifications

To be successful in this role, you should have at least:

B. Pharm degree.
5 years of experience in regulatory affairs within the pharmaceutical industry.
3 years of experience in team management.
Strong knowledge of regulatory requirements and guidelines.
Experience with regulatory submissions and interactions with health authorities.
Excellent communication and interpersonal skills.
Profound knowledge about regulatory processes and activities related to Life Cycle Management (LCM) activities.
Attention to detail and ability to work in a fast-paced environment.
Fluent in Hebrew and English.

About The Department

The Regulatory Affairs department at Novo Nordisk plays a crucial role in ensuring compliance with regulatory requirements and driving the approval and maintenance of our products. Located at our headquarters in Denmark, the department consists of a dedicated team of regulatory professionals who work collaboratively to navigate the complex regulatory landscape. The atmosphere is fast-paced and dynamic, with a strong focus on teamwork and continuous improvement. Join us and contribute to our mission of improving the lives of millions of patients worldwide.

Working at Novo Nordisk

We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.

Contact

Please click on "apply now" and submit your resume in English.

Deadline

Apply before 01/05/2024