(Senior) Regulatory Affairs Manager - HN

(Senior) Regulatory Affairs Manager - HN

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 750 members, AstraZeneca is investing into Vietnam 360 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 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/Government 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.
• Position company in Pharma industry and government bodies to ensure industry positions aligned with AstraZeneca’s goals

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?

Be bold and make a powerful impact: AstraZeneca is a world-leading business where standards are high and challenges complex, but also a collective where we build, support and motivate each other. This unique combination of strong expectation and empowerment invites you to improve how our markets work and make your individual mark. Here, you can follow your ambitions with full confidence. As part of a responsible, value-led business with a strong sustainability agenda, you can also help impact the future beyond business projects.

Be part of our growth journey and success story: Join the fastest growing pharmaceutical company in our markets, set up to fuel further growth. Make the most of our assets: our strong heritage, our early investment and commitment in emerging markets, and how we embrace digital and data to transform the patient journey. Go beyond your limits. Welcome failure as a chance to learn. There’s no better place to feel inspired, energised and try new things.

Learn and grow by embracing diverse opportunities: Experience an organisation where professional development is prized and nurtured. Access the tools and support you need to continuously learn. Then it’s up to each of us to step up, speak up and show what we can do. Take advantage of working in a global business with opportunities to move beyond your role and open international doors. At AstraZeneca, your future is in your own hands.

Urgently bring our leading pipeline to millions of patients in need: Seize the opportunity to help improve the lives of millions of patients, including in areas where patient needs are often unmet. Work with our transformative pipeline to help bring a variety of high-quality medicines to market – and ensure they are made easily accessible to as many patients as possible.

Be heard in a culture of local empowerment: AstraZeneca is set up for creativity. We encourage unity and ownership at a local level, with collaboration across the global organisation. We tailor how we work, adapting to our markets and healthcare systems. In our diverse community, every voice is important. Share your ideas and opinions openly. In our speak-up culture, the way we communicate with each other leads to more powerful innovation.

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/ and Facebook https://www.facebook.com/AstraZenecaVN

Contact us via recruitment.Vietnam@astrazeneca.com

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.