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Regulatory and Policy Strategy Lead

3 months ago

Hanoi, Hanoi, Vietnam AstraZeneca Full time

Regulatory and Policy Strategy Lead

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 positively contribute to AstraZeneca success by monitoring regulatory policy developments and shaping the regulatory environment, 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/ Develop and execute strategies
to monitor regulatory policy developments
and shape the regulatory environment**- Develop and deliver strategies and action towards maintaining long-term relationships and enhancing engagement levels to key policymakers and external stakeholders (government officials, drug regulators, trade associations and senior leaders in the healthcare field)

  • Develop and implement policy programs to support company's strategic business operations
  • Drive trends in policies, guidelines and regulations relating to healthcare matters to support patient access
  • 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
  • Identify and assess regulatory and policy developments, trends, risks and issues, prioritizing resources to fully manage and shape the regulatory environment for key areas
  • Position company in Pharma industry and government bodies to ensure industry positions aligned with company's goals

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

  • Maintain detailed knowledge of critical aspects of products: commercial strategies, content of the dossiers, regulatory intelligence, regulatory timeline, supply strategy
  • Develop submission strategy in joint agreement with identified stakeholders and optimise the balance between risk and commercial benefits, ensure the adequate allocation of resources and the on time delivery of the plans
  • Make sure local regulatory strategies are consistent with global product strategies and local priorities
  • Monitor proactively and effectively evaluation progress of product license registration, negotiate and interact with regulatory authorities to achieve the approval

3/ 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.
  • At least 5 years working experience in Regulatory and Government Affairs function
  • 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.
  • Strong English communication and presentation
  • Proactive and highly committed to support and deliver results.
  • High Sense of Ownership and accountability for achievement.
  • Highly organized and selfdisciplined.
  • High level of integrity and good morals.
  • Networking and influencing skills.
  • Analytical skills.
  • Selfmotivated and