Regulatory Affairs Manager – Nordic

Regulatory Affairs Manager – Nordic

Exciting opportunity within generics

Broad role – operational and tactical
In this RA-position, you get to operate with all local Regulatory Affairs issues related to the product portfolio in the Nordic countries and take a vital part in the fast growth of Glenmark's establishment within the Nordic.

You will establish interaction and cooperation with the respective countries Health Authorities and provide inputs to the necessary dossier and timely submission for all product launched in the Nordic in close cooperation with the market authorisation holder Glenmark UK.

Based in Glenmark Nordic HQ in Malmö, and with direct report to the VP RA Europe based in UK, you will be in contact with a wide range of different stakeholders both internally and externally.

Key tasks in a very visible role
You will be working on submissions, packaging and approvals on a wide range of products – many of which will change local market dynamics.

· Successfully interact with the project and functional teams in Europe and India to ensure that data generated is appropriate and will be presented and compiled in accordance with EU requirements

· Manage the submission process (generally DCP, MRP, CP or national submissions) and manage the national phase for MA issue following closure of the European Regulatory Procedures

· Post-approval activities including maintenance of approved MAs and launch activities

· Assistance in compilation of compliance files for new license approvals and updating compliance files during life cycle of the product where necessary

· Liaise with external companies with respect to in-licensing and out-licensing activities and any associated regulatory issues as required

RA experience from the pharmaceutical industry
We expect you to have a degree in pharmaceutical science or other relevant education combined with 3-5 years of experience from a Regulatory Affairs position within an affiliate or HQ in the pharmaceutical industry. You have great stakeholder management skills and are able to prioritize and focus on key commercial projects. You are a skilled communicator, and you can work with both internal and external partners – both international and regional.

In other words, this is your opportunity to take your established knowledge and experience from local regulatory affairs into a regional level. You are now ready to develop yourself and take the next step in your career in a dynamic and diverse position in a fast-growing pharmaceutical company.

Apply for this unique position with Pharma
The recruitment process is carried out in collaboration with the consulting company Compass Human Resources Group A/S.
Please submit your CV and application in English on www.compasshrg.com - If you would like to find out more about this position before submitting your application, please do not hesitate to contact Tom Zehngraff, Compass on tel.: +45 70 20 12 75. Please note that we will reply to the email address from which you send your CV.

Glenmark is a leading integrated research-based, global pharmaceutical company established as a leading player in the discovery of new molecules both NCEs (New Chemical Entity) and NBEs (New Biological Entity). Glenmark has several molecules in various stages of pre-clinical and clinical development and are primarily focused in the areas of Oncology, Respiratory and Dermatology. Glenmark branded generics business has a significant presence in markets like US and Western Europe as well as India. Glenmark API business sells products in over 80 countries including the US, various countries in the EU, South America and India.

With 17 manufacturing facilities and 5 R&D centers dedicated to the goal of enriching lives across the globe we believe that the real force behind our continued successes are dedicated employees from across 50 nationalities, committed to creating 'A new way for a new world'. For more information, visit www.glenmarkpharma.com

Deadline for application: As soon as possible
Workplace:
Malmö
Reference: 1801.248
Company:
Glenmark
Mer info
Telefon +4570201275
Område Malmö stad
Yrkesroll Hälsa & Sjukvård, Medicin & Farmaci
Typ av anställning Heltid, Tillsvidareanställd
Sista ansökningsdag 12 aug (52 dagar kvar)

Om arbetsgivaren

Glenmark is a leading integrated research-based, global pharmaceutical company established as a leading player in the discovery of new molecules both NCEs (New Chemical Entity) and NBEs (New Biological Entity). Glenmark has several molecules in various stages of pre-clinical and clinical development and are primarily focused in the areas of Oncology, Respiratory and Dermatology. Glenmark branded generics business has a significant presence in markets like US and Western Europe as well as India. Glenmark API business sells products in over 80 countries including the US, various countries in the EU, South America and India.

With 17 manufacturing facilities and 5 R&D centers dedicated to the goal of enriching lives across the globe we believe that the real force behind our continued successes are dedicated employees from across 50 nationalities, committed to creating 'A new way for a new world'. For more information, visit www.glenmarkpharma.com