International Regulatory Affairs Director

3 weeks ago

Petaling Jaya, Malaysia AstraZeneca Full time

**_Are you a strategically focussed Regulatory professional with international experience and would like to play an integral part in bringing life changing medicines to patients? If you are please read on._**

At AstraZeneca, we make a difference every day by delivering life-changing medicines to millions of people globally. Creating a more agile and inclusive environment means building an inspiring culture where we celebrate innovative thinking. This means we are opening up new ways to work, ground-breaking methods and bringing excellent teams together. Above all, we are passionate about science and driven to always put patients first. Join us and be part of an exceptional place to work

We have an opportunity for an **International Regulatory Affairs Director (IRAD) **to join our team. International Regulatory Affairs (InRA) drives innovative, international, regulatory and patient-centric strategies, enabling simultaneous global access to our products. The International region consists predominantly of Emerging Markets, with some developed markets. We have a three-pillar strategy in International: Expansion, Innovation and Partnership.

You will provide strategic leadership and have an understanding of regulatory science across international regions. Your experience and knowledge of drug/biologic development processes and strategies will enable you to influence cross-functional discussions with product teams. A thorough understanding of international commercial factors is needed for success in this role.

**Key accountabilities / responsibilities**:
**Project Regulatory Strategy**
- Develop and implement innovative regulatory strategies designed to deliver a rapid approval. Strategy should reflect international requirements.
- Develop, communicate and update the International section of the Regulatory Strategy Document for assigned products/projects.
- Deliver regulatory milestones including assessment of the probability of regulatory success together with risk and mitigation measures.
- Lead the objective assessment of emerging data against aspirations and update leadership teams on project risks and mitigation activities.

**Leadership**
- Single point of contact and Regional Regulatory Affairs representative on Regional Product Teams (across the International Markets)
- Plan and create the International dossier
- Build and implement an optimal regulatory strategy for product(s) ensuring International needs are incorporated into the Global Regulatory Strategy that in turn contributes to the Global Product Development Plan.
- Ensure business needs are understood within the Global Regulatory Strategy Team; encourage regional commercial engagement with proposed regulatory strategies, risks and mitigation plans.
- Ensure effective regulatory representation in partnership with appropriate technical experts at all health authority meetings and clear documentation of the discussion and agreements.
- Coach, mentor and lead regulatory teams to ensure objectives are successfully delivered to time and quality.
- Provide leadership in product in-license/due diligence review, product divestment and product withdrawal.
- Proactively contribute across RAD community and Regulatory Excellence objectives and activities.

**Regulatory Environment**
- Partner with commercial teams to monitor changes in the regulatory environment; support and advise accordingly.
- Collaborate with commercial colleagues to influence guidance within leading Health Authorities.

**Essential Criteria**:

- Bachelor’s degree in a science related field
- Previous experience with Major Health Authority interactions
- Extensive knowledge of regulatory drug development including product approval/launch.
- Broad background in pharmaceutical business and experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority.
- Leadership and program management experience.
- Ability to think strategically and critically evaluate risks to regulatory activities within a complex, critical, high-profile development program.
- Successful contribution to a major regulatory approval in the International Region
- Commercial and cross-cultural awareness; can work independently with Commercial and Marketing Company colleagues from across the globe.
- Must demonstrate competencies of: critical thinking, strategic influencing, innovation, initiative, leadership and proficiency with both written and verbal communications.

**Location**:Petaling Jaya, Malaysia

**Salary**: Competitive + Excellent Benefits

Next steps, if the role looks suitable to you please apply

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