Regulatory Affairs Manager for AstraZeneca

Arbetsbeskrivning

This is a consultancy assignment where you will work as Regulatory Affairs Manager at AstraZeneca in Mölndal. 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.
The assignment is to coordinate and execute all regulatory tasks in the delivery of submissions. This means that you will:
- Prepare and deliver regulatory operational plans for allocated projects/products.
- Contribute to solutions to regulatory issues.
- Project manage quality regulatory submissions to agreed project targets.
- Provide operational regulatory input and guidance in cross-functional teams.
- Work flexibly within and across Therapeutic Areas to provide broad regulatory support to ensure the delivery of product team and business objectives.
Responsibilities:
- Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents
- Identify potential regulatory risks to the operational plans, and propose options to mitigate risks.
- Acting as a project coordinator for nominated products/projects, work effectively with global regulatory affairs personnel and with global/regional cross-functional teams to plan, prepare and deliver both simple and increasingly complex submissions which will achieve the following across a range of markets
- Monitor, interpret and validate current and changing regulatory legislation and share potential impact these activities may have on the product development program
- Support RAD or assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies


Vem är du?

- University Degree in Science or related discipline
- 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
- 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 the successful candidate has experience from Regulatory Affairs from medical device or the pharmaceutical business.

Du erbjuds

We can offer you a challenging role in a truly global company. This is a consultant assignment which means that you will be hired by Jurek Rekrytering & Bemanning, but working as a consultant at AstraZeneca.

This assignment will start as soon as possible and will go on for 9 – 12 months. The recruitment process is ongoing, so please send in your application as soon as possible at www.jurekbemanning.se
If you have questions, please contact recruitment consultant Louise Nilsson: louise.nilsson@jurekbemanning.se or 0766-331448

Om företaget

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. AstraZeneca is one of the world's leading pharmaceutical companies. At AstraZeneca, we promote a culture that inspires innovation and collaboration.