Regulatory Affair Manager - Sweden

1 day left

Company
AL2S3 LTD
Salary
40,000 - 60,000
Posted
26 Oct 2018
Closes
22 Feb 2019
Ref
ramanswed
Contract Type
Permanent

Regulatory Affairs Manager - Sweden

AL Solutions are looking for a Regulatory Manager to work for a market-leading Scandinavian CRO and to be based in Sweden (Uppsala or Stockholm).

This is an opportunity to join a mid-sized organisation that is rapidly expanding and at the heart of innovation. They truly believe in a work-life-balance and have many benefits to evidence this.

The company currently has a headcount of near 200 currently working within clinical development.

 

Responsibilities

  • Complete projects/services according to the agreement with project manager, line manager and customer
  • Report progress of projects and other services according to agreement with project manager, line manager and customer
  • Behaviour according to our promises (quality, punctuality, communication) and values (credibility, focus on solutions, job satisfaction)
  • Contribute to the development of your area of expertise
  • Main responsibilities Completing task(s) according to applicable regulations, agreements and budget
  • Ensuring that defined objectives and plans are met and complied to
  • Ensuring customers’ positive perception of the collaboration with
  • Active project participation
  • Regulatory submissions for approvals of new products, line-extensions; managing the preparation, content and format of the dossier, responding to authority questions for medicinal products
  • Driving submissions of variations and renewals
  • Liaison with Health Authorities
  • Preparation and maintenance of product information
  • Review and approval of packaging materials
  • Clinical trial applications
  • Pharmacovigilance responsibilities
  • Occasional Translations, Compliance and other tasks.

 

 

Experience/Qualifications

  • Basic education within relevant field, equivalent to degree from University or University College, formal education may be compensated by experience
  • Experience within Regulatory Affairs
  • Ability to show initiative
  • Ability to work independently
  • Knowledge about Pharmaceuticals and Biotech Products

 

 

AL Solutions are a niche Life Science recruitment consultancy. We place professionals across the UK/EU for a variety of biotechnology, pharmaceutical and CRO companies ranging from small start-ups to large global organisations.

 

If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.al2s3.com or reach out to us via:

 

Tel: +44 (0) 203 778 0909

Email: alexander@al2s3.com

 

Apply for Regulatory Affair Manager - Sweden

Already uploaded your CV? Sign in to apply instantly

Apply

Upload from your computer

Or import from cloud storage

Your CV must be a .doc, .pdf, .docx, .rtf, and no bigger than 1MB


4000 characters left

Marketing Communication

We'd love to send you information about Jobs and Services from PharmiWeb.jobs by email.

All emails will contain a link in the footer to enable you to unsubscribe at any time.


When you apply for a job we will send your application to the named recruiter, who may contact you. By applying for a job listed on PharmiWeb.jobs you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us.