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Sr. Specialist Regulatory Affairs Manager - Finland

MSD Finland is seeking a talented Senior Regulatory Affairs Manager with location Espoo

Your new role
On behalf of MSD, Hays is now looking for a Senior Specialist Regulatory Affairs Manager. The position will be based in Finland. As the Senior Specialist Regulatory Affairs Manager you will be part of a regulatory team of 12 and report directly to the Executive Director Regulatory Affairs Nordic & Baltics.

In this position you will ensure timely preparation, submission and appropriate follow-up of new marketing authorization applications for the assigned products to the local authorities and if applicable, to the EMA. You will work with accurate and compliant labelling translations and artwork preparation as well as stay updated on late MSD pipeline filings, relevant EU and local regulations and guidelines. You will be responsible to develop and maintain positive relationship with key players in the regulatory environment.

You will work alongside the Business Divisions, locally, regionally and globally, to support business initiatives in sub region for the assigned products. Further you will keep well-informed of local and international regulatory legislation, identify and track regulatory changes/trends that might impact MSD business and contribute to keeping the local RA team members updated on new legislation and RA requirements through attendance in courses/workshops. You will secure compliance with respect to product quality, safety and GDP according to local requirements.

What you'll need to succeed
We are looking for a person who hold a Master’s degree in pharmacy or other relevant life science area with a minimum of four years’ experience in a registration department, which should include dealing directly with regulatory agencies. You should be familiar with local and EU legislation procedures and guidelines governing pharmaceutical products and have quality experience in GDP. You should have good computer experience and have proficiency in Finnish and English language. Translating experience in regulatory affairs and strong translating skills from English into Finnish and back would be considered as an advantage.

As a person you should have attention to detail, are flexible to successfully handle conflicting time pressures and a large volume of work as well as the ability to work effectively in a highly regulated environment. It is important to have good communications skills, as well as good organizational and planning skills. Further you have a client oriented approach and work according to the MSD leadership vision, a team player approach is essential and an appreciation of the interactions and relationships of the department with other groups internally.

What you need to do now
In this recruitment MSD is working with Hays Life Sciences. If you're interested in this role, then click 'apply now' to forward an up-to-date copy of your CV and personal letter in one document. For inquiries regarding the position or process please contact the responsible recruitment consultant Therese Bodell, therese.bodell@hays.com. Selection of candidates will be carried out continuously, so be sure to send in your application as soon as possible.

Your new company
MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, they are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us. Their ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, MSD strive to create an environment of mutual respect, encouragement and teamwork. As part of their global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. MSD is an equal opportunities company proudly embracing diversity in all is forms. Find out more about your next career step at MSD visit us at www.msd.com.



Sammanfattning

Jobbtyp:
Rekrytering
Industri
Pharma
Ort
Finland
Specialisering
Life Sciences;Administration;Sälj och Marknad
Ref:
896838
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Tala med en konsult

Tala med Therese Bodell, specialistkonsulten som hanterar denna position, i Stockholm

Hays, Sturegallerian, Stureplan 4C, Stockholm, Stockholm, 114 35

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