Regulatory Affairs Director, Global Regulatory Strategy

Boston, MA, USA

Full-TimeDepends on ExperienceSenior LevelMasters

Job Description

Welcome to AstraZeneca, a global biopharmaceutical company dedicated to improving the lives of patients worldwide. We are currently seeking a highly skilled and experienced Regulatory Affairs Director to lead our Global Regulatory Strategy team. As a key member of our regulatory affairs department, you will play a crucial role in developing and implementing regulatory strategies for our innovative portfolio of medicines. If you are passionate about ensuring compliance with regulatory requirements and have a strong track record of success in global regulatory affairs, we encourage you to apply for this exciting opportunity. Join us in making a meaningful impact on patients' lives and shaping the future of healthcare.

Develop and implement global regulatory strategies for AstraZeneca's portfolio of medicines.
Lead and manage the Global Regulatory Strategy team, providing guidance and support to team members.
Ensure compliance with all relevant regulatory requirements and guidelines.
Stay updated on changes in global regulatory landscape and adapt strategies accordingly.
Collaborate with cross-functional teams to ensure timely and efficient regulatory submissions.
Represent AstraZeneca in interactions with regulatory authorities.
Provide strategic input to product development teams to ensure regulatory requirements are met.
Review and analyze scientific data to support regulatory submissions.
Monitor and report on the progress of regulatory submissions and provide updates to senior management.
Identify potential regulatory issues and provide recommendations for resolution.
Participate in the development and implementation of departmental policies and procedures.
Mentor and train team members on regulatory processes and requirements.
Maintain knowledge of industry best practices and ensure continuous improvement of regulatory processes.
Collaborate with other departments to ensure alignment of regulatory strategies with business objectives.
Ensure effective communication and collaboration with internal and external stakeholders.
Represent AstraZeneca in industry conferences and events to enhance company's reputation and relationships with regulatory bodies.
Adhere to ethical and professional standards in all interactions and decision-making.
Play a key role in shaping the future of healthcare by contributing to the development and approval of innovative medicines.

Where is this job?

This job is located at Boston, MA, USA

Job Qualifications

Extensive Knowledge Of Global Regulatory Requirements: The Ideal Candidate Should Have A Deep Understanding Of Regulatory Guidelines And Requirements In Major Markets Such As The Us, Eu, And Japan, As Well As Emerging Markets.
Strong Leadership Skills: As A Director, This Individual Will Oversee A Team Of Regulatory Professionals And Must Have The Ability To Lead, Mentor, And Manage Their Team Effectively.
Experience In Developing Global Regulatory Strategies: The Candidate Should Have A Proven Track Record Of Successfully Developing And Executing Regulatory Strategies For Global Drug Development Programs.
Excellent Communication And Negotiation Skills: The Role Involves Frequent Interactions With Regulatory Authorities, Key Stakeholders, And Cross-Functional Teams. The Candidate Should Have Excellent Communication Skills And The Ability To Negotiate Effectively To Achieve The Company's Goals.
In-Depth Understanding Of Drug Development Processes: The Candidate Should Have A Thorough Understanding Of The Drug Development Process And Be Able To Integrate Regulatory Requirements Into Overall Development Plans To Ensure Timely And Successful Submissions.

Required Skills

Risk Management
Quality Assurance
Drug development
Regulatory framework
Regulatory compliance
Clinical Trials
Regulatory Submissions
Market Access
Global Strategy
Labeling Compliance
International Regulations

Soft Skills

Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Attention to detail
Teamwork
Adaptability
Problem-Solving

Compensation

According to JobzMall, the average salary range for a Regulatory Affairs Director, Global Regulatory Strategy in Boston, MA, USA is $165,000 - $250,000 per year. This range may vary depending on factors such as the individual's level of experience, the specific company and industry, and the individual's education and certifications.

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 PostedApril 25th, 2025

Apply BeforeJanuary 4th, 2026

This job posting is from a verified source.

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