Experience

MSD Norge

• Norway
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Specialist Regulatory Affairs

  • Jan 2022 - Present

  Back in local Regulatory Affairs after an assignment within Regional Regulatory Affairs. Regulatory lifecycle management of medicinal products within different therapeutic areas, NP, MRP and CP procedures. Cross functional teamwork with Market Access, Medical, Marketing and Logistic. Acting as subject matter expert for different databases within the Regulatory field. Back in local Regulatory Affairs after an assignment within Regional Regulatory Affairs. Regulatory lifecycle management of medicinal products within different therapeutic areas, NP, MRP and CP procedures. Cross functional teamwork with Market Access, Medical, Marketing and Logistic. Acting as subject matter expert for different databases within the Regulatory field.



MSD

• Software Development

• EMEA Labeling Liaison Sr Specialist

  • Oct 2020 - Jan 2022

  A temporary assignment as Regional Labelling Liaison. Dedicated to the labelling processes including compliance activities. Includes interactions with country Regulatory Affairs within the EMEA region as well as HQ. Support of cross-divisional digital projects that aims to simplify, accelerate, automate and focus forward the end-to-end labelling process. A temporary assignment as Regional Labelling Liaison. Dedicated to the labelling processes including compliance activities. Includes interactions with country Regulatory Affairs within the EMEA region as well as HQ. Support of cross-divisional digital projects that aims to simplify, accelerate, automate and focus forward the end-to-end labelling process.

• Senior Specialist Regulatory Affairs

  • Jun 2017 - Oct 2020

  Same tasks as for Specialist Regulatory Affairs. Highly involved in a working group preparing implementation of Serialization/FMD in Norway and at Nordic level within the company.

• Specialist Regulatory Affairs

  • Mar 2014 - May 2017

  Lifecycle management of medicinal products within different therapeutic areas. Type I and type II variations for national, MRP and CP products, as well as new MAA. Cross functional teamwork with Market Access, Medical, Marketing and Logistic. Acting as subject matter expert for different databases within the Regulatory field.



At home

• Individual and Family Services
• 1 - 100 Employee

• Jobbsøker

  • Aug 2013 - Feb 2014

  Moved back from Texas this summer. Looking for a new position. Moved back from Texas this summer. Looking for a new position.



Home

• Individual and Family Services
• 300 - 400 Employee

• Expat

  • Aug 2010 - Jul 2013

  The family was seconded to Katy/Houston, Texas, for my husband’s employer DNV. Classes taken: Entrepreneurship & Economic Development (Houston Community College), NLP Practitioner, Strategic Tools for Managing Organizational Change (RICE). I have volunteered at my children’s school and The Norwegian Seamen’s church, and done a lot of social networking. The family was seconded to Katy/Houston, Texas, for my husband’s employer DNV. Classes taken: Entrepreneurship & Economic Development (Houston Community College), NLP Practitioner, Strategic Tools for Managing Organizational Change (RICE). I have volunteered at my children’s school and The Norwegian Seamen’s church, and done a lot of social networking.



Inpac AS

• France
• Architecture and Planning

• Gruppeleder - Produktutvikling, Analyse

  • Sep 2007 - Aug 2010

  Manager, responsible for 8 employees. Prepared regulatory documents for pharmaceutical products for approval by authorities (variations applications and new submissions). Worked according to international regulatory guidelines, current quality standards and –systems (incl. Good Manufacturing Practice (GMP) and International Conference on Harmonization (ICH)). Scientific supervisor and responsible for review, approval and quality control of documents. Implemented new routines for stability testing at the plant. Planned, performed and followed-up stability testing on pharmaceutical products. Show less

• Ingeniør

  • Jun 2007 - Aug 2007

  Qualified 2 climatic chambers with respect to temperature and humidity, for stability testing. Responsible for planning, performing and reporting qualification (PQ).



GE Healthcare

• Medical Equipment Manufacturing
• 200 - 300 Employee

• Forsker og Avdelingsleder

  • Feb 1999 - May 2007

  Responsible for stability work of contrast media in multidisciplinary and international R&D projects. Designed test plans, performed and documented the studies according to international regulatory guidelines and current quality standards and –systems (incl. GMP, ICH and CTD) to be used for submissions or variations applications. Performed statistical analyses on stability results and recommended shelf-life and storage conditions. Supervisor and approval function in the department. 5 months temporary position as Manager for Dep. of Stability Studies with 8 employees (June 2002 – October 2002). Show less



Forsvarets Forskningsinstitutt (FFI)

• Norway
• Research
• 700 & Above Employee

• Kjemiingeniør

  • Mar 1993 - Aug 1996

  Development of analytical methods for environmental pollutants (PCB and PAH) in water, soil and sediment. The procedure was extraction, and used GC-FID or HPLC for determination. Development of analytical methods for environmental pollutants (PCB and PAH) in water, soil and sediment. The procedure was extraction, and used GC-FID or HPLC for determination.



Vannanalyselaboratoriet i Buskerud

• Kjemiingeniør

  • Jun 1992 - Mar 1993

  Temporary position. Physical-chemical analyses of water from watercourses and treatment plants. Office work. Temporary position. Physical-chemical analyses of water from watercourses and treatment plants. Office work.