Global Regulatory Affairs Director

AstraZeneca; Kendall Square (MA); On-site; USD 186,000 - 279,000; Full time

Job summary

AstraZeneca in Massachusetts is seeking a senior regulatory leader to guide development, regulatory strategy, and lifecycle management for assigned products. You will influence authorities, apply global trends, and drive compliant submissions across product teams. Candidates should have a life science degree, 6+ years in regulatory drug development, and proven leadership.

A master's/PhD is a plus. Join a collaborative, fast-paced environment that values courageous leadership and cross-functional

Qualifications

• Bachelor's Degree in Life Science or related discipline.
• Advanced degree (MS, PharmD or PhD) a plus.
• 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

Responsibilities

• Provide strategic and operational regulatory leadership to the development, commercialization and life cycle management of the assigned products in product teams.
• Apply knowledge of current local and global Regulatory trends to identify future regulatory requirements and strategies.
• Influence Regulatory authorities through regular contacts to improve Regulatory outcomes.
• Ensure 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
• Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration

Skills

Regulatory leadership

Regulatory strategy

Project management

Stakeholder collaboration

Education

Bachelor's Degree in Life Science

MS/PhD or PharmD a plus

Job description

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. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.

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.
• Apply knowledge of current local and global Regulatory trends to identify future regulatory requirements and strategies.
• Influence Regulatory authorities through regular contacts to improve Regulatory outcomes.

Accountabilities:

• 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

Basic Qualifications:

• Bachelor's Degree in Life Science or related discipline,
• Advanced degree (MS, PharmD or PhD) a plus.
• 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

The annual base pay for this position ranges from $186,232 to $279,349. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

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.

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.