Regulatory Affairs Managers for AstraZeneca

Presentation

For AstraZeneca we are now looking for two or more Regulatory Affairs Managers for Consultant Assignments for 9-12 months with possibility for extension.

Interviews and selections are held on an ongoing basis so please apply today!

Arbetsuppgifter

As a Regulatory Affairs Manager you will be responsible for project management and coordination of the content of all regulatory submissions sent to health authorities and ensures that products meet all legal requirements, both regarding new products as well as for new indications, new markets license renewal, etc. You will coordinate and execute all regulatory tasks in the delivery of submissions.

As a Regulatory Affairs Manager you will:

- prepare and deliver regulatory operational plans
- contribute to solutions to regulatory issues
- quality regulatory submissions
- operational regulatory input and guidance in cross-functional teams
- work within and across Therapeutic Areas to provide broad regulatory support to ensure the delivery of product team and business objectives
- provide regulatory expertise on regulatory submissions
- provide health authority briefing documents
- identifying potential regulatory risks to the operational plans
- propose options to mitigate risks
- act as a project coordinator for nominated products/projects
- work effectively with global regulatory affairs personnel
- work with global/regional cross-functional teams to plan, prepare and deliver both simple and increasingly complex submissions
- monitor, interpret and validate current and changing regulatory legislation
- support RAD or assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies

Utbildning/erfarenhet

You hold an University Degree in Life Science or related discipline and two years experience of working in one or more areas in Regulatory Affairs in the pharmaceutical or related industry, or experience at a Health Authority. You have excellent written and verbal communication skills, thorough knowledge of the drug development process, Scientific knowledge sufficient to understand all aspects of regulatory issues, Strong ability to work collaboratively. An important requirement is that you have experience from Regulatory Affairs from medical device or the pharmaceutical business.


Förmåner

We take good care of our consultants and we offer social activities, as well as help in planning your future career. Your consultant manager is well experienced from your field, and knows how to get the most out of your assignment.

As a Poolia employee, you are included in the requirements concerning agreements on terms of employment by Unionen. Moreover, you get a grant for working out at your choice of place. You are also covered by a health insurance.

Företagsbeskrivning

Poolia Life Science can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden’s leading pharmaceutical and life science companies. So whether you’re interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you.

Working as a consultant suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you’re looking for a world of exciting assignments and new contacts, you’ll like being a consultant.

Sluttext

Please apply by registering your CV here on our website. Click on the "Ansök" button to the right of this advertisement. It is our recommendation that you register as much information as possible and that you attach a complete CV-document. Please check that your correct e-mail adress is registered.

Poolia is a registered staffing agency, meaning that we comply with the requirements set by Bemanningsföretagen - the Swedish Association of Staffing Agencies.

Language

en-GB