CMC Regulatory Affairs Associate Director II

Job Title: CMC Regulatory Affairs Associate Director II

Global Career Level: E

Introduction to role

Are you a strategically focused Regulatory CMC professional eager to play an integral part in bringing life-changing medicines to patients? If so, please read on!

As a CMC Regulatory Affairs Associate Director II, you will provide essential CMC Regulatory Strategy, operational, tactical, and decision-making expertise for projects and complex product ranges from early clinical development through to launch and post-approval lifecycle management for global markets. You will represent CMC Regulatory Affairs across various business networks, including Pharmaceutical Development Project teams, Global Regulatory Strategy Teams, Global Supply Teams, and Global Quality and Operations. You may also lead the development of new guidance, policy, and processes, facilitating high-quality partnerships within and external to AstraZeneca. Your role will support CMCRA for products/projects and/or specialist areas, with a deep understanding of the complexities and challenges required for Dossier submissions and proven project management skills.

Accountabilities

- Provide CMC RA expertise across business functions and potentially lead key business improvement initiatives.
- Offer strategic CMC RA expertise and direction for CMC submissions across the product lifecycle, supporting novel strategies and new approaches from technical functions.
- Lead CMC-related interactions with Health Authorities when necessary.
- Provide regulatory strategic guidance in support of operational initiatives, such as complex/accelerated projects and post-approval changes.
- Contribute to or lead policy setting and strategy development in the CMC RA environment within or external to AstraZeneca.
- Share knowledge by leading/contributing to Communities of Practice across groups or within a business unit.
- Manage high-level risk by making complex judgments and developing innovative solutions, including proactive risk management and mitigation.
- Provide clear, concise guidance on current CMC regulatory requirements to support business tactical and strategic planning.
- Support the development and implementation of novel strategies in CMC regulatory affairs to enhance efficiency and flexibility in the CMC dossier.
- Contribute to cross-therapeutic non-drug projects and support business processes to ensure accelerated submissions, launch activities, regulatory information management, and regulatory compliance on behalf of AstraZeneca.

Essential Skills/Experience

- Bachelors degree in Science, Regulatory Sciences, or Pharmacy.
- Breadth of knowledge of manufacturing, project, technical, and regulatory project management.
- Strong understanding of regulatory affairs globally.
- Direct Regulatory Affairs CMC experience with submissions for synthetics and/or biologic and biotechnology-derived products.
- Stakeholder & Project management.

Desirable Skills/Experience

- Masters degree or PhD in Science, Regulatory Sciences, or Pharmacy.
- Business, financial, and supply chain understanding/awareness.
- Experience with regulatory health authority interactions, inspections, and/or external advocacy/regulatory policy.
- Experience in line and/or matrix leadership.
- Experience with clinical development of innovative pharmaceutical APIs and Drug Products.