Regulatory Affairs Manager – Data Management

Barcelona, Spain

Full-TimeDepends on ExperienceSenior LevelMasters

Job Description

Are you a highly organized and detail-oriented professional with a passion for maintaining compliance in the pharmaceutical industry? Do you have experience in data management and a strong understanding of regulatory requirements? AstraZeneca is seeking a motivated Regulatory Affairs Manager to join our team and oversee data management for our products. As a key member of our Regulatory Affairs department, you will play a crucial role in ensuring that our products meet all regulatory standards. If you are dedicated, driven, and have a strong background in regulatory affairs and data management, we encourage you to apply for this exciting opportunity.

Oversee data management for all products within AstraZeneca's portfolio.
Ensure compliance with all regulatory standards and requirements.
Stay up-to-date on changes in regulations and communicate any updates to relevant teams.
Develop and maintain processes and procedures for data management and regulatory compliance.
Collaborate with cross-functional teams to ensure timely and accurate submission of regulatory documents.
Conduct audits and assessments to identify and address any compliance issues.
Work closely with external partners and regulatory agencies to resolve any regulatory issues.
Prepare and submit regulatory filings and responses to regulatory agencies.
Maintain accurate and organized records of all regulatory documents and submissions.
Provide guidance and training to team members on regulatory requirements and data management processes.
Conduct risk assessments and implement strategies to mitigate potential compliance risks.
Participate in internal and external meetings to represent the regulatory affairs department.
Monitor and track timelines for regulatory submissions and ensure timely completion.
Collaborate with other departments to ensure compliance with regulatory requirements throughout the product development process.
Continuously improve and streamline processes to enhance efficiency and effectiveness.

Where is this job?

This job is located at Barcelona, Spain

Job Qualifications

Excellent Communication And Interpersonal Skills, With The Ability To Effectively Collaborate With Cross-Functional Teams And External Stakeholders.
Bachelor's Degree In A Related Field Such As Life Sciences, Pharmacy, Or Chemistry.
Minimum Of 5 Years Of Experience In Regulatory Affairs, Specifically In Data Management.
Thorough Understanding Of Regulatory Requirements And Guidelines For Drug Development And Submissions.
Strong Project Management Skills, With The Ability To Handle Multiple Projects Simultaneously.

Required Skills

Quality Assurance
Process Improvement
Project Management
Data Analysis
Clinical Research
Risk assessment
Data governance
Regulatory compliance
Regulatory Submissions
Regulatory Strategy
Pharmacovigilance

Soft Skills

Communication
Conflict Resolution
Leadership
Time management
Interpersonal Skills
Organization
Critical thinking
Teamwork
Adaptability
Problem-Solving

Compensation

According to JobzMall, the average salary range for a Regulatory Affairs Manager – Data Management in Barcelona, Spain is between €50,000 and €70,000 per year. This may vary depending on the specific company, level 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 LanguagesSpanish

Job PostedApril 25th, 2025

Apply BeforeJuly 23rd, 2025

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