Director, Global Regulatory Affairs Early Respiratory & Immunology

Gaithersburg, MD, USA

Full-TimeDepends on ExperienceSenior LevelMasters

Job Description

Are you a driven and experienced regulatory affairs professional looking for your next challenge? Do you have a passion for improving respiratory and immunology treatments on a global scale? AstraZeneca is seeking a highly qualified and motivated Director of Global Regulatory Affairs to lead our Early Respiratory & Immunology team. In this role, you will play a critical role in shaping the regulatory strategy for our early stage respiratory and immunology portfolio. We are looking for a strategic thinker with strong leadership skills and a deep understanding of global regulatory requirements. If you are ready to make a meaningful impact and drive innovation in the field of respiratory and immunology, we want to hear from you.

Develop and execute regulatory strategies for AstraZeneca's early stage respiratory and immunology portfolio.
Lead and manage the Early Respiratory & Immunology team, providing guidance and direction to team members.
Keep abreast of global regulatory requirements related to respiratory and immunology treatments and ensure compliance with these regulations.
Collaborate with cross-functional teams to ensure timely and accurate regulatory submissions and approvals.
Identify potential regulatory risks and develop mitigation strategies to minimize impact on the company's portfolio.
Serve as the primary point of contact for regulatory agencies and establish strong working relationships with key stakeholders.
Provide strategic input and guidance to product development teams on regulatory requirements and potential roadblocks.
Stay informed about the latest developments in the field of respiratory and immunology, and use this knowledge to inform regulatory strategies.
Represent AstraZeneca at regulatory meetings and conferences, communicating the company's regulatory strategy and priorities.
Mentor and develop team members, fostering a culture of continuous learning and growth.
Collaborate with other departments, such as clinical development and commercial teams, to ensure alignment and integration of regulatory strategy with overall business goals.
Drive innovation and continuous improvement in the regulatory affairs function, developing and implementing best practices and processes.
Ensure timely and accurate reporting of regulatory activities to senior management.
Monitor and track regulatory changes and updates, evaluating their impact on AstraZeneca's portfolio and proactively making recommendations.
Act as a subject matter expert on regulatory affairs, providing guidance and support to cross-functional teams and senior leadership.

Where is this job?

This job is located at Gaithersburg, MD, USA

Job Qualifications

Advanced Degree In Life Sciences Or Related Field: A Successful Candidate For This Position Should Have A Minimum Of A Master's Degree In A Relevant Scientific Discipline, Such As Pharmacology, Biology, Or Chemistry. An Advanced Degree In A Related Field Such As Regulatory Affairs Or Public Health Is Also Desirable.
Extensive Experience In Global Regulatory Affairs: The Director Of Global Regulatory Affairs Early Respiratory & Immunology Should Have A Strong Background And At Least 10 Years Of Experience In Global Regulatory Affairs, Preferably In The Pharmaceutical Industry. This Includes Experience In Developing And Executing Global Regulatory Strategies, And A Thorough Understanding Of Regulatory Requirements And Guidelines.
Proven Leadership Skills: This Role Requires A Leader Who Can Effectively Manage And Motivate A Team Of Regulatory Professionals, As Well As Collaborate With Cross-Functional Teams To Achieve Common Goals. The Ideal Candidate Should Have At Least 5 Years Of Experience In A Leadership Role, With A Track Record Of Successfully Managing And Developing Teams.
In-Depth Knowledge Of Respiratory & Immunology Therapies: Astrazeneca Is A Leading Pharmaceutical Company In The Respiratory And Immunology Space, So A Strong Understanding Of These Therapeutic Areas Is Crucial For This Role. The Ideal Candidate Should Have A Deep Understanding Of The Disease Areas, Current Treatment Landscape, And Emerging Trends In Respiratory And Immunology Therapies.
Excellent Communication And Interpersonal Skills: As A Director Of Global Regulatory Affairs, This Role Requires Frequent Communication And Interaction With Internal Stakeholders, Regulatory Authorities, And External Partners. The Ideal Candidate Should Possess Excellent Communication And Interpersonal Skills To Effectively Represent Astrazeneca And Negotiate With Regulatory Agencies.

Required Skills

Product Development
Global regulations
Scientific writing
Team Leadership
Risk assessment
Labeling
Cross-Functional Collaboration
Clinical Trials
Regulatory Strategy
Compliance Oversight
Submissions Management

Soft Skills

Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Teamwork
Active Listening
Adaptability
Problem-Solving

Compensation

According to JobzMall, the average salary range for a Director, Global Regulatory Affairs Early Respiratory & Immunology in Gaithersburg, MD, USA is $200,000-$250,000 per year. This may vary depending on the specific company, years of experience, and other factors.

Additional Information

AstraZeneca is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Required LanguagesEnglish

Job PostedFebruary 19th, 2024

Apply BeforeJuly 8th, 2026

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