Regulatory Affairs Specialist

Location:

Warsaw, Masovian, Poland

Salary:

Competitive

Type:

Contract

Start Date: 

As Soon As Possible

Contract Period: 

To Be Confirmed

Main Industry:

Search Finance, Banking & Insurance Jobs

Other Industries & Skills: 

Engineering Health, Nursing & Social Services, Information Technology, Legal, Management & Executive, Manufacturing, Media, Sales

Job ID:

126697459

Posted On: 

14 April 2023

Do you dream of a career with a global pharmaceutical company built on life-changing innovations? Do you want to drive the due diligence process, directly impact the projects with your scientific knowledge, and set the regulatory direction?
If it sounds interesting for you, then this is your chance to join us, as a Regulatory Affairs Specialist based in Warsaw, Poland.
 

Apply now and join a life-changing career!

Position
As our Regulatory Affairs Specialist, you will be responsible for coordinating and supervising Regulatory Affairs applications related to Product Life Cycle Management (LCM) and/or New Drug Approvals (NDA) and provide support as required. You will also develop, review and update labelling and ensure Regulatory Affairs compliance in promotional material according to local legislation and Standard Operation Procedures (SOPs). You will be in constant business relations with internal and external professionals.
Your key accountabilities will be:
•    preparing and submitting documentation related to the marketing authorization of medical products (post approval variations) – MRP/DCP, NP procedures
•    translating and verifying of product information and proofreading of product labelling – CP, MRP/DCP, NP procedures
•    verifying the correctness of documentation for compliance with European guidelines and Polish law
•    cooperating with URPL, GIF and the company’s headquarters.
 

The role is temporary assignment- for 6 months. Based in Warsaw, Poland.

Qualifications

To be considered, for this position you need to be accurate, detail-oriented person. You need to have responsibility and commitment to the implementation of the assigned task and ability to work in the team.
To be successful in this role we expect you to have:
•    higher education (preferably education in the field of pharmacy/biology/chemistry or related).
•    practical professional experience in the field of registration of medical products, drugs (experience in the completion and preparation of documents for registration procedures). 
•    very good knowledge of English and Polish in speech and writing.

About the department
Our Regulatory Affairs, Quality Assurance and Pharmacovigilance Team is responsible for all Novo Nordisk medicinal products and medical devices available in Poland. And we are the integrated part of Clinical, Medical and Regulatory Department.
Regulatory Affairs (RA) is responsible for Life Cycle Management of medicinal products and medical devices. As we share other functions there is a strong collaboration with Pharmacovigilance and Quality functions and with regional/global teams. We are currently looking for a new colleague with a strong scientific background who has a genuine interest in being part of our dynamic team.

Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.

Contact
For further information please apply your CV via the online recruitment system.

Deadline
Apply before April 27th, 2023.

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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