Regulatory Affairs Manager - HCM

Regulatory Affairs Manager - HCM

About AstraZeneca and AstraZeneca Vietnam

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

AstraZeneca Vietnam

As a Foreign Invested Enterprise with over 700 members, AstraZeneca is investing into Vietnam 310 million USD from 2020 to 2030 with a focus on reducing the burdens of non-communicable diseases, developing local talent, and uplifting the domestic biopharmaceutical R&D and manufacturing capabilities.

Over the last three decades accompanying Vietnam’s sustainable development, AstraZeneca has run several impactful programmes in collaboration with the Government, Ministry of Health and healthcare partners to promote disease awareness, prevention and early detection. In recent years, AstraZeneca Vietnam has received several certificates of merit from the Prime Minister and Minister of Health, for excellent contributions to Vietnam’s vaccine diplomacy, fight against COVID-19 and advancement of cancer treatment and disease awareness. The company has also been recognized among Vietnam’s Top 100 Best Places to Work (2018 – 2024) with various other industry awards from BritCham, EuroCham, and government agencies.

What you’ll do

Job Description / Capsule

• To positively contribute to AstraZeneca success by obtaining registration licenses through the fastest approvals for all products in Vietnam in line with business plan.

  Adherence to AZ and industry codes of conduct, ethics, pharma code and good regulatory practices

Typical Accountabilities

1/ Maintain the awareness of the regulatory environment

Monitor and understand the impact of external changes in the regulatory and political environment that will impact on the product portfolio

Communicate the impact of changes to key stakeholders and seek their involvement where necessary.

2/ Develop and execute regulatory strategies to quickly achieve the approval as well as facilitate the rapid product launching

Maintain detailed knowledge of critical aspects of products: commercial strategies, content of the dossiers, regulatory intelligence, regulatory timeline.

Develop submission strategy in joint agreement with identified stakeholders and optimise submission and approval.

Make sure local regulatory strategies are consistent with global product strategies and local priorities

Develop regulatory plan in conjunction with key stakeholders, ensure the adequate allocation of resources and the on-time delivery of the plans.

Track status and take prompt corrective measures whenever necessary to ensure rapid approval and launching.

3/ Maintain the product licenses

Monitor the status of the product licenses and allocate adequate resources to license maintenance.

Maintain the complete documentation records.

Monitor and setting timelines for license variations and renewal approvals.

4/   Others:

Manage submission and approval for GMP site registration in time.

Provide qualified documents to support hospital tender application.

Support cross-functional team to develop strategic plans, launch activities and provide counsel within regulatory areas for assigned projects

5/External stakeholder interaction:

Monitor proactively and effectively evaluation progress of license extension/license registration, negotiate and interact with regulatory authorities during review to ensure submission approval.

Initiate and maintain relationship with regulatory authorities including Drug regulators and various MoH/ non-MoH State departments through government supportive activities.

6/ Adherence to AZ and industry code of conduct, ethics, pharma code and good regulatory practices and ensure high standard of regulatory practices.

Education, Qualifications, Skills and Experience

Essential

• University graduation in Pharmacy or Medicine.

• 5 years working experience in Regulatory Affair Department.

• Excellent interpersonal skills - capable of working and relating with senior authorities.

• Have strong knowledge and understanding of local regulatory requirements and processes.

• Knowledge of Pharmacy products development process.

• Good command in English skills.

• Proactive and highly committed to support and deliver results.

• High Sense of Ownership and accountability for achievement.

• Highly organized and self-disciplined.

• High level of integrity and good morals.

• Analytical skills.

• Self-motivated and good team player.

Key Relationships to reach solutions

Internal (to AZ or team)

Country President, Commercial, KA, Medical Affairs, Clinical, Corporate Affairs, MCOQ, Supply, Distribution, HR, Finance, International Regulatory Affairs

External (to AZ)

Regulatory Authorities, Distributors, Hospitals and Health Professionals, Key Opinion Leaders (Regulatory), Local Trade Associations, Legal Professionals

Why AstraZeneca?

At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and fuel your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and is always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.

What will you get?

We provide driven packages and benefits for proficient and qualified candidates; a winning dream team and colleagues who share ONE values, ideas, and goals.

So, what’s next?

If you are already inspiring yourself to join our dream team, we can’t wait to hear from you.

If you are ready to bring new insights 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 take initiative to recruitment.Vietnam@astrazeneca.com. We encourage your application.

Where can I find out more?

Visit our website www.astrazeneca.vn

Follow us on LinkedIn www.linkedin.com/company/astrazeneca/

Contact us via recruitment.Vietnam@astrazeneca.com

Date Posted

18-thg 11-2025

Closing Date

30-thg 12-2025

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.

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 authorisation and employment eligibility verification requirements.