Regulatory Affairs Manager

Do you have expertise in Regulatory Affairs and a passion to accelerate innovative science? Would you like to apply your expertise to impact multiple internal and external stakeholders that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

ABOUT ASTRAZENECA

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

At AstraZeneca, we unlock the power of what science can do. Empowered to explore, everyday we work towards our ultimate aim – treating, preventing, modifying and even curing complex diseases.

BUSINESS AREA

Work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need and healthcare professionals. The place to push beyond the traditional ‘Regulatory’ mindset – innovation is at our heart. We think broadly about patients and what it takes to prevent and treat diseases. Powering us to both manage balanced risks as well as spot opportunities.

What you’ll do

As Regulatory Affairs Manager, you will prepares/agrees/executes global/regulatory tactical submission plans for allocated project/prod that implements the agreed regulatory strategy to develop and maintain products. Provides independent tactical/scientifically related guidance cross functional on aspects of regulatory affairs. Uses knowledge and experience in the regulatory field to influence functional objectives.                                                                                     

Essential for the role

• Apothecary Degree or Degree in Science.

• Significant experience of working in one or more areas in regulatory affairs in the pharmaceutical or related industry, or in regulatory drug development, product approval/launch, line extension and licence maintenance, or experience at a health authority

• At least 7-8 years of experience in Regulatory Affairs Function, with at least some experience in MNC Pharma company.

• Project and process management

Desirable for the role

• Drives Performance – holds others accountable to high standards and clarifies what needs to be done and the consequences for the individual and/or the organization

• Works collaboratively – respects and integrates diverse views into decisions/proposals

• Problem solving

Why AstraZeneca?

Here you’ll have the opportunity to make a meaningful difference to patients’ lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world’s most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and shaping the patient ecosystem.

With our ground-breaking pipeline, the outlook is bright. Be proud to be part of a place that has achieved so much, yet is still moving forward. There’s no better time to join our global, growing enterprise as we lead the way for healthcare and society.

So, what’s next?

• Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

• Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.

• If you’re curious to know more then please reach out to Aziza Fitriani. We welcome your application.

Where can I find out more?

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Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.