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MSD (Merck Sharp & Dohme) is a global healthcare leader working to address unmet health needs. We provide innovative medicines, vaccines, biologic therapies and consumer and animal health products to help improve health and well-being. We work with customers in 140 countries to deliver broad-based healthcare solutions. For our Nordic Cluster, we are currently recruiting a

Regulatory Affairs Specialist

Are you an experienced Regulatory Affairs Specialist, with a passion for innovation and excellence?

If so we are currently looking for candidates like you, to join our Regulatory Affairs team.

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. With a diversified portfolio of prescription medicines, vaccines and animal health products, MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Main Responsibilities

  • Preparation, submission and appropriate follow-up of new Marketing Authorization applications to the local authorities and – as applicable – to the EMA.
  • Ensuring maintenance of assigned, authorized products through timely submission of variations, renewal applications and supplemental marketing authorizations.
  • Creates and ensures high quality labeling translation and artwork management.
  • Ensures up to date knowledge on relevant EU and local regulations and guidelines.
  • Responsible for the collection and distribution of regulatory intelligence
  • Maintains a positive relationship with internal and external regulatory contacts.

Qualifications

  • Educated to B.Sc in pharmacy or other life science.
  • Has minimum of 2 years’ experience in the pharmaceutical Industry, in a regulatory, medical or similar position.
  • Ability to communicate well verbally and in writing is essential, as are good organizational and planning skills.
  • Possess a meticulous attention to detail and be flexible enough to successfully handle conflicting time pressures and a large volume of work.
  • Must be able to work both alone and as part of a team
  • The incumbent must demonstrate proficiency in Danish and English language 

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.

About MSD in the Nordics

For over 125 years and counting MSD has revolutionized global health care. Today, more than 800 people work for MSD in the Nordics alone. Innovation is our life’s blood, and you will be a part of developing new and customer centric health care solutions that go beyond medicine to help people be well and live better lives during treatment. We have a strong pipeline of products within medicines, vaccines, biologic therapies and animal health products. We work every day to make healthcare accessible to as many as possible, which requires top talent within both R&D, marketing, finance, health economy and policy shaping. Globally, we operate in 140 countries and demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. For more information, visit www.workforlife.com.

Apply online Gem job

Arbejdssted

Copenhagen

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