Global Regulatory Affairs Director

AstraZeneca • Cambridge, MA

1d • $186,232 - $279,349 • Hybrid

About The Position

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. In this role, you will provide strategic and operational regulatory leadership to the development, commercialization and life cycle management of the assigned products in product teams. You will apply knowledge of current local and global Regulatory trends to identify future regulatory requirements and strategies, and influence Regulatory authorities through regular contacts to improve Regulatory outcomes.

Requirements

• Bachelor’s Degree in Life Science or related discipline
• 6 years experience of regulatory drug development, manufacture, commercialization or equivalent
• Proven successful leadership and project management experience
• Broad background of experience of working in several groups in regulatory affairs or experience at a health authority
• Knowledge of regulatory procedures and legislation for drug development, product registration, line extension and licence maintenance

Nice To Haves

• Advanced degree (MS, PharmD or PhD)

Responsibilities

• Provides effective lobbying and influencing on regulatory agencies and trade associations on product and legislative development issues and monitors changes in the regulatory environment in nominated region to support and advise relevant functions
• Provides strategic regulatory advice support for product developments regional therapy area
• Represents AZRA on relevant external Trade Association committees to ensure AZRA and/or AZ views on key issues are known
• Ensures adequate risk assessments and mitigation plans are included in the regulatory strategy documents
• Contribute effectively to Global Development programmes, providing expert advice and interpretive inputs on market legislation and requirements that impact on new and existing product registrations
• Ensures effective collaboration across the global, regional and local Regulatory Affairs interface enabling rapid and effective submissions, approvals and other product maintenance activities
• Participates in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project
• Ensures all markets remain in compliance with product licences maintained and ensuring improvement plans are in place to close compliance gaps. Provide support and advice on training and development to ensure all regulatory personnel in markets have an appropriate knowledge of quality and compliance
• Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration

Benefits

• Eligibility for various incentives
• Opportunity to receive short-term incentive bonuses
• Equity-based awards for salaried roles
• Qualified retirement programs
• Paid time off (i.e., vacation, holiday, and leaves)
• Health coverage
• Dental coverage
• Vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Director