International Regulatory Affairs Director
Welcome to AstraZeneca – a leading global pharmaceutical company dedicated to transforming the lives of patients around the world. We are currently seeking a highly experienced and motivated International Regulatory Affairs Director to join our dynamic team. As the International Regulatory Affairs Director, you will play a crucial role in ensuring compliance with regulatory requirements, driving successful global product registrations, and ultimately bringing life-changing medicines to patients in need. We are searching for a candidate with a strong background in regulatory affairs, a deep understanding of global market regulations, and a passion for making a positive impact in the healthcare industry. If you are a driven individual with a desire to make a difference, we invite you to apply for this exciting opportunity at AstraZeneca.
- Develop and implement global regulatory strategies for new and existing products in collaboration with cross-functional teams.
- Stay up-to-date on global regulatory requirements and communicate changes and updates to relevant internal stakeholders.
- Lead and manage the submission and approval process for global product registrations.
- Provide regulatory guidance and support to teams across different regions and countries.
- Collaborate with internal and external stakeholders to ensure timely and successful submissions.
- Build and maintain strong relationships with regulatory authorities in key markets.
- Conduct regulatory risk assessments and develop mitigation strategies.
- Ensure compliance with all relevant regulations and guidelines.
- Lead and manage regulatory audits and inspections.
- Represent the company in meetings with regulatory authorities.
- Provide regulatory support and expertise to cross-functional teams throughout the product development process.
- Monitor and report on regulatory trends and developments that may impact the company.
- Mentor and develop junior regulatory affairs staff.
- Develop and maintain standard operating procedures and processes related to regulatory affairs.
- Collaborate with other departments, such as legal, medical affairs, and marketing, to ensure alignment on regulatory strategies and activities.
Advanced Degree In A Relevant Field, Such As Pharmacology, Chemistry, Or Biomedical Sciences.
At Least 10 Years Of Experience In Regulatory Affairs, With A Focus On International Markets.
In-Depth Knowledge Of International Regulatory Requirements And Processes, Including Fda, Ema, And Other Global Agencies.
Proven Track Record Of Successful Regulatory Submissions And Approvals For Pharmaceutical Products In Multiple Countries.
Strong Leadership And Communication Skills, With The Ability To Work Effectively With Cross-Functional Teams And External Stakeholders.
Quality Assurance
Strategic Planning
Global regulations
Compliance Management
Risk assessment
Stakeholder management
Cross-Functional Collaboration
Clinical Trials
Regulatory Submissions
Regulatory Strategy
Pharmacovigilance
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Teamwork
Active Listening
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a International Regulatory Affairs Director in Petaling Jaya, Selangor, Malaysia is approximately RM 15,000 to RM 25,000 per month. This range can vary depending on the specific industry, company, and individual qualifications and experience.
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AstraZeneca plc is a British-Swedish multinational pharmaceutical and biopharmaceutical company.
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