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Senior Specialist Regulatory Affairs Job

Date: Nov 9, 2017

Location: Espoo, ES, FI

Company: MSD

Requisition ID: REG003067

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


For our Regulatory Affairs team in MSD Finland we’re currently recruiting for a:

Specialist Regulatory Affairs

Position overview:



  • For assigned products, ensures timely preparation, submission and appropriate follow-up of new Marketing Authorization applications to the local authorities and – as applicable – to the EMA.

  • Ensures maintenance of assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations.

  • For assigned products ensures timely, accurate and compliant labeling translations and artwork preparation.

  • For assigned products and tasks, stays updated on late MSD pipeline filings, relevant EU and local regulations and guidelines and to develop and maintain positive relationship with key players in the regulatory environment. Designs and implements regulatory ad-hoc local action plans, as necessary.

  • Collects relevant public available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.

  • For assigned products and tasks, works alongside the Business Divisions, locally, regionally and globally, to support business initiatives in sub region.

  • Keep abreast of local and international regulatory legislation, identifies and tracks regulatory changes/trends that might impact MSD business and contributes to keeping local RA team members updated on new legislation and Regulatory Affairs requirements through attendance in courses/workshops.

  • Closely cooperates with Quality Responsible Person (QRP) and regional Quality Contact Persons. Ensures handling of customer complaints, CAPA and change management according to MSD standards and local procedure.

  • Secures compliance with respect to product quality, safety and Good Distribution Practices according to local requirements.

Qualifications

Education, Experience and Skills Required:



  • Minimum – Master’s degree in pharmacy or other life science. Degree in translation is an advantage.

  • A minimum of 4 years’ experience in a Registration Department, which should include dealing directly with regulatory Agencies.

  • Translating experience in regulatory affairs and strong translating skills from English into Finnish and back would be considered as an advantage

  • A sound appreciation of the interactions and relationships of the department with other groups internally is expected.

  • Must have client oriented approach and work according to the MSD leadership vision.

  • The incumbent must be familiar with local and EU legislation procedures and guidelines governing pharmaceutical products.

  • Quality experience GDP related experience is highly preferable

  • Ability to communicate well verbally and in writing is essential, as are good organizational and planning skills. The incumbent should possess a meticulous attention to detail, and be flexible enough to successfully handle conflicting time pressures and a large volume of work.

  • Team player

  • Ability to work effectively in a highly regulated environment

  • A mature and disciplined approach to work is essential

  • Diplomacy and assertive skills in dealing with internal and external parties.

  • Proficiency in Finnish and English language as well as PC use with regard to word-processing, spread sheets, database application, and internet.


For more information please contact: Country RA Lead, Anna Siira, +358 9 804 65 268

Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.


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. This role will be open to applications until 24th of November 2017.



Job: Regulatory Affairs Generic
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Employee Status: Regular
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Company Trade Name: MSD


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