Regulatory Affairs Manager

To develop future treatments in the Respiratory and Immunology Therapy Area

Hays Life Sciences is now looking to recruit 3 Regulatory Affairs Managers to develop future treatments in the Respiratory and Immunology Therapy Area for 1-year contract assignments at AstraZeneca in Gothenburg.

Do you have knowledge within Regulatory Affairs and want to develop your skills within project management?

At AstraZeneca, we offer you a unique experience to work in cross functional teams with all phases of drug development, from clinical trials to marketing authorization applications worldwide. You will lead the end-to-end planning, coordination and execution of our submissions and contribute to regulatory submission strategy. Does this match your skills and ambitions for the future? Then join us to develop future treatments in the Respiratory and Immunology Therapy Area.

At AstraZeneca, we are more than 65.000 people in over 100 countries. Our aim is simply to positively impact patients' lives together, as our pipeline of innovative medicines consistently grows. As an industry leading Regulatory function, we're focused and committed to the development of our products as well as to our people.

The role
We are now seeking new members to join our Regulatory Affairs Management team within the Respiratory and Immunology Therapy Area, in the role as Regulatory Affairs Manager (RAM).The role will be based at AstraZeneca's dynamic R&D site in Gothenburg, Sweden. With employees from more than 50 countries, our Gothenburg site is a truly inspiring place to work.

What you'll do
Working in the role as Regulatory Affairs Manager (RAM) you will contribute to regulatory submission strategy, identify submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval.

Your main accountabilities/responsibilities:

* Lead and/or contribute to the planning, preparation, and delivery of submissions of varying complexity throughout the product's life cycle from either a global and/or regional perspective.
* Provide regulatory input/ expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including submission delivery strategy of all dossiers and all application types per market and/or region and review of documents, e.g., response documents, study protocols, periodic safety reports
* Support operational and compliance activities for assigned regulatory tasks
* Provide coaching, mentoring and knowledge sharing within the regulatory skill group
* Contribute to and lead process improvement
* Identify regulatory risks and propose mitigations to appropriate member of cross functional teams

Do you have the essential qualifications for these roles?
To be successful in this role, we believe that you have a University degree in science or a related field and a minimum of 2 years of regulatory experience within the biopharmaceutical industry or similar.
We believe that you possess good project management skills as well as leaderships skills and that you have excellent written and verbal communication skills. If you have previous experience in leading multi-disciplinary project teams, this will be an advantage.

If you are ready to invest in yourself and your regulatory career, then this is the right challenge for you.