Regulatory Compliance Officer or Manager - Sweden

3 days left

Company
AL2S3 LTD
Salary
60,000 - 80,000
Posted
20 Nov 2018
Closes
22 Feb 2019
Ref
refaffswede
Contract Type
Permanent

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:

alexander@al2s3.com | +44 (0) 203 778 0909

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