Global Regulatory Affairs Director

Job Title: Global Regulatory Affairs Director

Location: Gaithersburg

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.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

Introduction to Role:

Provides strategic and operational regulatory leadership to the development, commercialisation and life cycle management

of the assigned product(s) in product teams. Applies knowledge of current local and global Regulatory trends to identify

future regulatory requirements and strategies. Influences Regulatory authorities through regular contacts to improve

Regulatory outcomes.

Responsible for the management of a skill group such as CMC, Regulatory affairs project management, etc. Responsible for

skill development, performance management, resource allocation.

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

Essential Skills/Experience:

• Bachelor’s Degree in Life Science or related discipline,
• Advanced degree a plus.
• 6 years experience of regulatory drug development,
• Manufacture, commercialisation 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

Where can I find out more?

• Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
• Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
• Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en
• Our US Footprint: Powering Scientific Innovation - YouTube

The annual base pay (or hourly rate of compensation) 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 and commissions for sales 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.

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing [email protected].

Date Posted

Closing Date

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.