Regulatory Affairs and Pharmacovigilance Specialist

Singapore Job Openings

Novo Nordisk

Singapore

November 19, 2024

Regulatory Affairs and Pharmacovigilance Specialist

Category: Reg Affairs & Safety Pharmacovigilance

Location:Singapore, Singapore, SG

Are you passionate about regulatory compliance and patient safety? Do you have a knack for navigating complex regulatory environments? If so, you might be the perfect fit for our Regulatory Affairs & Pharmacovigilance (PV) Specialist role at Novo Nordisk Singapore. Read more and apply today for a life-changing career.

About the department
Novo Nordisk Singapore supports both Singapore and Brunei. Our team is dedicated to ensuring regulatory compliance for new products and product amendments, thereby maintaining our license to operate. We work closely with health authorities and policymakers to shape future regulatory frameworks. Our Safety Pharmacovigilance function safeguards patients by ensuring medicines are safe to use, collecting and analysing safety data, and addressing any product safety issues that arise. Join our dynamic and collaborative team to make a meaningful impact on patient safety and regulatory compliance. This role will report directly to RA and PV Manager.

Novo Nordisk Singapore has been consistently recognized as the employer of choice in Singapore for 4 consecutive years - Best Places to Work from 2021 to 2024.

The position
As a Regulatory Affairs & PV Specialist you will coordinate and supervise Regulatory Affairs applications related to product Life Cycle Management (LCM) and/or New Drug Approvals (NDA), renewals. Develop, review and update labelling and ensure RA compliance in promotional material according to local legislation and Standard Operation Procedures (SOPs).

Monitor regulatory environment and ensure full compliance with relevant legislation and with internal SOPs.
Coordinate and supervise and manage the submissions of Regulatory Affairs applications related to NDA and LCM (renewal and miscellaneous applications).
Update internal database and folders so that they reflect the registration status and LCM updates accurately.
Provide regulatory and PV support and insight to key stakeholders and monitor the pharmacovigilance environment and ensure compliance.
Act as Local Pharmacovigilance Responsible Person (LPRP), establish and maintain a Pharmacovigilance system in the affiliate.

Qualifications

University degree in Biology or pharmaceutical related studies or life sciences.
Minimum 1 year experience in the pharmaceutical industry.
Minimum 1 year experience in the Regulatory as a Regulatory Affairs Associate.
Knowledge of local legislation. Regional legislation awareness desirable.
Fluent in oral and written English.

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 energize 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
Upload your CV to our online career page (click on Apply and follow the instructions).

Deadline
03 December 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.

#LI-AMS1

We regret to inform you that this job opportunity is no longer available as it has expired

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