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Senior Specialist, Regulatory Affairs Job

Date: Nov 9, 2017

Location: Drammen, 06, NO

Company: MSD

Requisition ID: REG003400

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.

MSD’s Regulatory Affairs division helps bring new medical advancements to the world by facilitating the communications and procedures that allow swift, organized compliance across regulatory agencies. As a team of energetic, results-driven individuals, we’re a global network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices, and solutions to the world on time, every time.

For our Regulatory Affairs Department in Drammen we are currently recruiting a:

Senior Specialist, Regulatory Affairs

The Regulatory Affairs Department
The Regulatory Affairs (RA) department is responsible for local submission and follow-up of marketing authorizations for new MSD products, and for regulatory lifecycle management of marketed MSD products. Currently, we are a team of 8 persons (2 males and 6 females) who value a good working environment with flexibility, open communication, and cheerful mood.
Our office is located at Papirbredden science center in approx. 5 minutes walking distance from Drammen train station.

The position
The Specialist RA will be one of 7 product liaisons in the RA team and will have regulatory responsibility for assigned medicinal products, including products in late part of the pipeline, in cooperation with MSD headquarters and MSD regional office, local Medicines Agency (SLV), Nordic RA colleagues, and cross-functional local colleagues. Seniority will be considered depending on the candidate’s Qualifications and experience.

Main areas of responsibility:
  • Preparation and quality control of local product information and other relevant documents for submission of new product applications 
  • Local follow-up of new marketing authorizations and local life cycle management of current ones (e.g. variations applications, SPC/Patient insert, Felleskatalogen, artwork management)
  • Regulatory compliance
  • Regulatory intelligence related to assigned therapeutic area franchises
  • Close cooperation with local supply chain, PV department and Medical Information
  • Participation in local cross-functional project teams / launch excellence teams.
The Specialist RA will be reporting into the Regulatory Affairs Director, MSD (Norway) AS.

Qualifications

  • Master’s degree in pharmacy or equivalent life science education; 
  • Experience from Regulatory Affairs within a pharmaceutical industry or pharmaceutical government administration is highly preferable, but training will be provided as needed; 
  • Should preferably be familiar with local and EU regulatory procedures and guidelines governing pharmaceutical products;
  • Good communication skills (both oral and written) as well as good organizational and planning skills;
  • The preferred candidate should be flexible and able to demonstrate diplomacy and negotiating skills in dealing with others. A mature and disciplined approach to work is essential;
  • Structured and independent working methods, as well as being a good team player; 
  • Capability to address several tasks simultaneously combined with ability to work effectively in a highly regulated environment with tight schedules; 
  • Engaged, enterprising, quality-conscious, accurate, and a positive contributor to the working environment; 
  • A sound appreciation of the interactions and relationships of the RA department with other internal groups and departments is expected. The preferred candidate must have a customer focused approach and be able to work according to the MSD leadership standards.
  • Proficiency in Norwegian and English language (written and oral) as well as PC use with regards to word-processing, spreadsheets, database application, and internet. 
Our offer
Challenging and varied tasks and competitive working conditions in a dynamic, international and professionally oriented environment with good opportunities for personal and professional development.

Information
Application deadline is December 15th, 2017.
Questions and further information regarding the position can be addressed to RA Director Karl Johan Sundt, telephone (+47) 911 67 990 or via e-mail (karl.johan.sundt@merck.com).

A good place to work
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.

If you enjoy being challenged over and over again, but also like to have fun and contribute to a good team spirit and cooperation, MSD will be a good place for you to work. We invest heavily in the development of our people, and MSD gives you plenty of opportunities for individual initiative and responsibility.

About MSD in the Nordics
For over 125 years and counting MSD has revolutionised 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. 



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Company Trade Name: MSD


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