AstraZeneca

Regulatory Affairs Specialist - HCM (1 year contract)

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 550 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 – 2022) with various other industry awards from BritCham, EuroCham, and government agencies.

What you’ll do

Job Description / Capsule

• To implement regulatory strategies to gain rapid and high quality approvals and ensure high standard of regulatory compliance, in order to achieve the company’s business objectives.

Typical Accountabilities

• Maintain detailed knowledge of critical aspects of products: commercial strategies, content of the dossiers, regulatory intelligence, regulatory timeline, supply strategy.
• Develop and implement the milestones plan of drug registration
• Prepare qualified regulatory submission and handle product registrations for new, license extension and variation applications.
• Develop artwork required for packaging to secure new product launching and secure stock for sales
• Provide detailed information on regulatory status of affected products, and advise on appropriate regulatory processes.
• Maintain regulatory compliance databases and processes
• Monitor registration process to ensure timely submission, approvals of new product registration, license extension, and regulatory changes, in line with company strategic business goals.
• Prepare promotional material submission in line with local regulation, update status to cross-functional team in due time, negotiate effectively to protect claims
• Provide qualified regulatory documents, response to DAV/ hospitals questions supporting for tender in due time
• Manage efficiently matters related to Regulatory on stock-related issues and communicate with relevant cross-functional team in time, no stock shortage
• Provide comments on draft regulations.

Education, Qualifications, Skills and Experience

Essential

• University Degree in Pharmacy or Medicine.
• Good command in English skills.
• Knowledge of Pharmacy products development process and have strong knowledge and understanding of local regulatory requirements and processes.
• Proactive and highly committed to support and deliver results.
• High Sense of Ownership and accountability for achievement.
• Highly organized and self-disciplined.
• Good interpersonal skills - capable of working and relating with senior authorities.
• High level of integrity and good morals.
• Analytical skills.
• Self-motivated and good team player.

Desirable

Working experience at least 3 years in Regulatory Affairs, experience in vaccine area is preferable

Key Relationships to reach solutions

Internal (to AZ or team)

Marketing, Sales, KA, Logistics, Medical, Clinical, Global Product Teams, International Regulatory Affairs, Manufacturing Sites and QA, Regional Office, HR, Finance, Corporate Affairs Teams.

External (to AZ)

Hospitals and Health Professionals, Regulatory Authorities, Universities, Institutes.

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

29-thg 2-2024

Closing Date

30-thg 3-2024

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.

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