Telephone 0203 778 0909 | Email office@al2s3.com

Regulatory Affairs/Compliance Manager/Officer – Sweden

  • Location:
  • Salary:
    negotiable / 45k-50k SEK per month
  • Job type:
    Permanent
  • Posted:
    4 weeks ago
  • Category:
    Other
  • Deadline:
    October 26, 2019
  • Languages:
    English, Swedish

 

Regulatory Affairs/Compliance Manager/Officer – 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

 

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