Medella Life

Nordic RA Manager

7 days left

Location
København K, Hovedstaden (DK)
Salary
Negotiable depending on experience
Posted
06 Sep 2021
Closes
06 Oct 2021
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Be part of our journey
The position reports to the Nordic Head of Regulatory Affairs. It is positioned within a small Nordic team, which collaborates closely with the rest of the Nordic commercial team placed in all four Nordic countries as well as with external partners.

A glimpse of your new workday with us
In this position, you will be responsible for many diverse tasks within RA, QA, and PV. From managing RA changes to our many products to handling QA issues of varying complexity, in close collaboration with our internal supply and manufacturing function and external distribution partners, to reporting and filing adverse reaction cases. You will be responsible for our local Quality Management System (QMS), ensuring its ongoing suitability for our business needs.

Core responsibilities
Your work will consist of various tasks within the areas of

  • License renewals, variations, and new applications incl artwork
  • Quality
  • Regulatory strategy
  • Maintenance of regulatory databases
  • Compliance and Pharmacovigilance
  • Industry and corporate affairs relations

You will be a manager in a small Nordic team, ensuring excellent support to our commercial and supply teams, close contact, and direction - even at a distance.

In this role, it is vital that you develop constructive cross-functional relationships with colleagues across the region and the company business. By contributing to our local RA/QA/PV department structure and through direct contact with the Nordic authorities, you actively drive the regulatory direction.

Analytical, communicating, and effective
To have success in this position, you must have an analytical mind with strong attention to detail and problem-solving skills as well as good communication skills, written and verbal.

You hold a commercial understanding and can unfold effective time management and prioritization in a workday with sometimes multiple and overlapping deadlines.

You are fluent in Danish and English and have a knowledge of one or more regional local languages.

Your education and experience
A degree in pharmacy, veterinary sciences, or related fields and/or a minimum of 3-5 years of experience within Regulatory Affairs.

Authority and experience to be a Responsible Person in DK

Experience or knowledge of the animal health industry

Understanding of regulatory environment and trends, including legislative, market, and industry competitor developments

Detailed knowledge of relevant European legislation, licensing, and related practices and laws

IT literate. Able to use standard business software, communication tools, and quality management systems

Excellent Danish and English skills (written and verbal)

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