International Associate Regulatory Affairs Director I

Job Title: International Associate Regulatory Affairs Director I

Global Career Level: E

Introduction to role

Are you ready to be part of a team that transforms drug development strategies into reality? As an International Associate Regulatory Affairs Director I, you'll play a pivotal role in bringing life-changing medicines to patients across international markets. This permanent position within our International Regulatory Affairs Management (RAM) team offers a unique opportunity to navigate a rapidly evolving regulatory landscape alongside highly skilled professionals. Your expertise will drive the tactical delivery of submissions, ensuring no patient waits for the medicines they need. Are you prepared to embrace the variety of challenges and make a significant impact?

Accountabilities

As an Associate Regulatory Affairs Director I, you will:

- Provide expert regulatory advice and project management within the RAM team.
- Collaborate with International RADs to optimize and accelerate market submissions.
- Deliver efficient and streamlined tactical delivery of submissions for International markets.
- Communicate effectively to remove obstacles and support rapid filings.
- Share best practices within the RAM community for complex submissions.
- Partner with Regional Regulatory Contacts for knowledge-sharing.
- Maintain regulatory consistency and achieve "right-first-time" submissions.
- Drive the creation of International shared packs.
- Develop and maintain collaborative relationships to resolve issues.
- Contribute to Regulatory Intelligence initiatives.
- Understand regional trends and regulatory frameworks for applications.
- Coordinate, review, and author responses to Health Authority queries.
- Analyze regulatory procedures and special designations.
- Lead planning and delivery of complex regulatory maintenance submissions.
- Liaise with cross-functional members for aligned product responsibilities.
- Develop submission delivery plans and provide status updates.
- Manage project planning tools and resource demand changes.
- Identify regulatory risks and communicate mitigations.
- Support operational and compliance activities for deliverables.
- Provide coaching, mentoring, and knowledge sharing within the organization.
- Seek Continuous Improvement opportunities.

Essential Skills/Experience

- Relevant University Degree in Science or related discipline
- Extensive regulatory experience within the biopharmaceutical industry, with 10+ years working with International markets including new MAAs, CLE’s, licence maintenance and labelling
- Thorough understanding of drug development and International market Regulatory Frameworks
- Thorough knowledge of the regulatory New MAA roll-out, Clinical Line extension and product maintenance process
- Strong project and stakeholder management skills
- Highly developed interpersonal skills, leadership skills, including experience leading multi-disciplinary project teams
- Global working and expert knowledge of International markets
- Proven track record of management of complex regulatory deliverables for International market MAA’s, CLE’s and LCM activities across projects/products

Desirable Skills/Experience

Preferred Experience

- Great understanding of Global Regulatory processes and tools with in-depth International markets experience
- Managed complex regulatory deliverables across projects/products (across International & Global markets)
- Experience of working with people from locations outside of India, especially in the International regions
- Strong understanding of major global Health Authority procedures which have an impact on International reliance market strategies

Skills and Capabilities

- Excellent English written and verbal communication skills
- Cultural awareness
- Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
- Proficiency with common project management (e.g., MS Project, Office timeline pro etc.) and document management tools including Veeva Systems
- Ability to work independently and as part of a team
- Influencing and stakeholder management skills
- Ability to analyze problems and recommend actions
- Continuous Improvement and knowledge sharing focused

Internal and External Contacts/Customers

Global Regulatory Leads (GRLs)
Regulatory Regional Leads (e.g., US, EU, International RADs)
iRAMs, GRET members
Other R&D skill groups, e.g., Global Regulatory Operations, Global Labelling Group, Operations Regulatory, Patient Safety
Other internal Science Unit functions
Operations/Manufacturing organisation (iCMC)
Marketing Companies/Local affiliates
Health Authorities
External Collaboration partners

Reporting Relationship

Direct Reports - None
Indirect Reports - None

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, innovation drives us forward. We are committed to transforming our drug development strategies into reality by working at all stages of development. Our diverse team is empowered to make quick decisions, influence early on, and add value throughout the process. With a science-driven approach, we bring life-changing medicines to patients while continuously seeking improvements. Here, you'll find opportunities to expand your skills across varied stages and molecules, supported by a culture that values curiosity and collaboration.

Ready to make a difference? Apply now to join our dynamic team!

Date Posted

Closing Date

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.