Regulatory Assistant – HCM

Regulatory Assistant – HCM

The ideal candidate is a passionate, self-motivated, and detail-oriented team player who is committed to the success of our customers. Then AstraZeneca might be the one for you!

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 600 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 – 2022) with various other industry awards from BritCham, EuroCham, and government agencies.

What you’ll do

Job Description / Capsule

In addition to basic support, individual may support more Senior Managers and provide broader department support to a number of managers.  Tasks may include booking meetings, maintaining documentation, establishes systems and structures for day to day functioning of their responsibilities.  In some instances may supervise others and allocate resources as necessary.

Typical Accountabilities

(bullet point list)

Regulatory Affairs:

• Manage team activities calendar, responsible for logistics and organization of team’s events, meeting and activities.

• Coordinate internal and external meetings / conferences to ensure meetings run smoothly, including scheduling meeting times, making logistics and travel arrangements for attendees (hotel, air ticket, visa, transportation, meeting amenities)

• Follow up all Payments and Invoices. Track, monitor, update the Department budget.

• Manage all document and database related to Regulatory: Receiving, checking, filling, scanning, managing and archiving documents, request signature and stamp for documents when required.

• Work with vendor to support other activities (sponsorship, translation, notary…)

• Perform other administrative tasks for team and Head of department

Patient Safety:

• Prepare and track PSLL documents for submission to MOH, DI & ADR center and follow-up with AOR of PSLL submission.

• Prepare and track PBRER & DSUR documents for submission to DI&ADR center.

• Track submission/approval for PBRER & DSUR of marketed products and for PSLL of studies on ERV.

Education, Qualifications, Skills and Experience

Essential

• Bachelor’s degree

• 2 years of experience in event management, administration tasks execution & monitoring

Key Relationships to reach solutions
Internal (to AZ or team): Country President, Marketing, Medical, Clinical, HR, Finance, Regulatory Affairs, Patient Safety.

External (to AZ): Local Competent Authority, 3rd Parties/Vendors

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

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.