Associate Regulatory Affairs Director

Role: Associate Regulatory Affairs Director (ARAD)
Location: Warsaw

Model: hybrid 32

ABOUT ASTRAZENECA
At AstraZeneca every one of our employees makes a difference to patient lives every day. You may not feel youre at the frontline of research but your role in changing patients lives is critical. Our mission is ambitious and it takes the skills of a collaborative team to really deliver on what science can do and to always put patients first. Working at AstraZeneca we believe in the potential of our people and our commitment to develop our people beyond what was thought possible.

The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management experience and a track record of advancing innovative therapies through key clinical development milestones. As a key member of the global regulatory strategy team (GRST) you are responsible for partnering with senior regulatory experts to support the end-to-end regulatory strategy planning coordination and execution of assigned cell therapy projects. The ARAD is solutions-oriented and a key contributor to regulatory strategy development the identification of submission risks and opportunities and drives high quality global regulatory authority engagements and submissions. The ARAD provides regulatory expertise and guidance on the clinical development requirements including procedural and documentation requirements to regulatory and cross-functional teams working flexibly within and across regions to achieve business objectives.

Accountabilities/Responsibilities:

Partner closely with members of the global regulatory team to define stage appropriate regulatory strategy in alignment with global regulatory requirements and expectations to bring innovative cell-based gene therapies to patients.

Closely monitor evolving global and regional regulatory guidelines policies and procedures to support efficient scientifically rigorous and patient-centric development plans.

Lead and contribute to the planning preparation review and submission of regulatory submissions (e.g. IND CTA GMO BLA IVDR) s for cell-based gene therapies across all regions ensuring proper documentation and compliance with internal and external standards.

Advise the regulatory and crossfuntional teams of available opportunies to accelerate development by evaluating risks and identifying potential solutions to address regulatory hurdles.

Participate in meetings with Health Authorities to obtain direct exposure to regulatory feedback and to enable:

o Contribuition to submission delivery strategies for all dossiers and application types that are responsive to health regulatory authority advice;

o Analysis of regulatory procedures and special designations used during development authorizations and extension of the product.

Use and share best practices when handling various applications and procedures during

interactions with health authorities and in day-to-day work while operating in a highly dynamic environment.

Develop execute and maintain submission delivery plans submission content plans and proactively provide status updates to designated stakeholders.

Support some operational and compliance activities for assigned projects.

May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies.

Provide coaching mentoring and knowledge sharing within the Regulaotry Affairs Management skill group.

Contribute to governance meetings and process improvement.

Minimum Requirements Education and Experience

Relevant University Degree in Science or related discipline

Extensive regulatory experience within the biopharmaceutical industry or experience at a health authority

Thorough Knowledge of drug development

Strong project management skills

Leadership skills including experience leading multi-disciplinary project teams

Preferred Experience

Managed complex regulatory deliverables and submisisons across projects/products

Managed CTA or first wave Marketing Applications and/or LCM submissions with application of IVDR/GMO

Knowledge of AZ Business and processes

Experience and expertise using Artificial intelligence tools

Skills and Capabilities

Excellent 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) and document managementtools

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)

Regional Leads (eg US EU international RADs)

Lead RPM

Regulatory skill group in CGT

Marketing Companies

Health Authorities

External Collaboration partners

Why AstraZeneca

At AstraZeneca were dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Theres no better place to make a difference to medicine patients and society. An inclusive culture that champions diversity and collaboration and always committed to lifelong learning growth and development. Were on an exciting journey to pioneer the future of healthcare.

So whats next

Are you already imagining yourself joining our team Good because we cant wait to hear from you!

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.