Regulatory Affairs Associate

AstraZeneca GmbH; Mississauga; On-site; CAD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a passionate regulatory affairs expert to join their team. In this role, you will manage regulatory dossiers, ensuring compliance with local and global standards while collaborating with cross-functional teams. Your expertise will directly impact the development of transformative medicines for complex diseases, making a meaningful difference in patients' lives. With a strong commitment to innovation and patient-focused solutions, this is an exciting opportunity to contribute to groundbreaking projects in a dynamic environment. If you're ready to bring fresh ideas to the table, this role is for you!

Qualifications

• Minimum of 2 years in the pharmaceutical industry.
• Experience with BPOM regulations and drug development process.

Responsibilities

• Manage regulatory dossiers and ensure timely submissions.
• Participate in cross-functional teams and provide regulatory updates.

Skills

Regulatory Affairs

Communication Skills

Cross-Functional Teamwork

Customer-Focused Mindset

Knowledge of BPOM Regulations

Pharmaceutical Industry Experience

Education

Bachelor's Degree in Pharmaceutical Science

Job description

Do you have expertise in regulatory affairs and passion for seeing the safe and effective use of pharmaceutical medicines for patients? Would you like to apply your expertise to help turn our pipeline into reality? 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.

What you’ll do

Typical Accountabilities:

• Manage regulatory dossiers to meet BPOM requirements and ensure smooth submission within globally and locally agreed timelines.

• Take necessary actions to achieve committed approval timelines.

• Actively participate in cross-functional teams and provide updates on regulatory status to ensure alignment with commercial and company goals.

• Maintain global and local regulatory affairs databases within specified SOP timelines.

• Effectively manage product artwork in the Global Artwork System to ensure timely implementation in compliance with both global and local requirements.

• Oversee product life cycle management to ensure compliance with local regulations and AstraZeneca policies.

• Provide regulatory documents to support hospital listings, tenders, contracts, and other business needs.

• Familiar with clinical study and ensuring that clinical trials are conducted in compliance with applicable regulations and guidelines.

• Have a good relationship with Health Authorities (such as BPOM, Kemenkes, or BPJPH).

Essential for the role

• Bachelor's degree in Pharmaceutical Science.

• Minimum of 2 years of experience in the pharmaceutical industry.

• Demonstrated working knowledge of BPOM regulations.

• Experience working in cross-functional teams.

• Understanding of the drug development process.

• Strong written and verbal communication skills.

• Ability to collaborate and work effectively as part of a cross-functional team.

• Performance-driven with a strong sense of commitment.

• Customer-focused mindset.

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?

Our Social Media, Follow AstraZeneca on LinkedIn

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