Regulatory Affair Specialist

2 weeks ago

Hanoi, Hanoi, Vietnam AstraZeneca Full time

Regulatory Affair Specialist - HN

About AstraZeneca and AstraZeneca Vietnam


AstraZeneca is a global, science-led biopharmaceutical company with a British-Swedish heritage that focuses on the discovery, development, and commercialization of prescription medicines.

At AstraZeneca, science and patients are at the heart of everything we do.

Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

Established in 1994, AstraZeneca Vietnam has come a long way in 27 years of advancing Vietnam's healthcare.

We change lives through innovative science with $25mil in R&D investment ; 40 ongoing clinical trials with 2800+ patients; 44 partnered hospitals and 14 medicines involved in trials.

We have built strong public-private partnerships for sustainability and healthcare access through many programs and activities such as Healthy Lung, Young Health Program, Careme, Giá Như, Health System Sustainability & Resilience, Green Energy for Health, Response to Covid-19.

We have gained some recognition for our efforts from the Minister of Health's Certificates of Merits for outstanding contributions to advancing cancer treatment and exceptional contributions to Vietnam's fight against COVID ; BritCham 2021 Awards for Contributions to healthcare and 25+ years of service in Vietnam; Ho Chi Minh Communist Youth Union's Medal and Certificate of Merit for contributions to youths (2021); Excellent Leadership - Visionary Leader Award (2021); HR Excellence - Workplace Culture Award and Vietnam's Top 100 Places to Work Award

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

Drug registration and promotional material registration

  • 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
  • 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.
  • Prepare promotional material submission in line with local regulation, update status to crossfunctional team in due time, negotiate effectively to protect claims

2. External activities

  • Initiate, build up and maintain the external relationships with regulatory authorities to achieve regulatory outcomes.
  • Actively collect all relevant regulatory information and update regulatory environment on time to crossfunctional team, Global team.

3. Others

  • Provide qualified regulatory documents, response to DAV/ hospitals questions supporting for tender in due time
  • Manage efficiently matters related to Regulatory on stockrelated issues and communicate with relevant crossfunctional team in time; no stock shortage
  • Provide comments on draft regulations.

Education, Qualifications, Skills and Experience

Essential

  • University graduation 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 selfdisciplined.
  • Good interpersonal skills capable of working and relating with senior authorities.
  • High level of integrity and good morals.
  • Analytical skills.
  • Selfmotivated and good team player.

Desirable

  • Working experience at least 3 years in Regulatory Affairs Department.

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?:

So, what's next?:

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

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