Associate Director, Regulatory Affairs - CMC

Santa Monica, CA, USA

Full-TimeDepends on ExperienceSenior LevelMasters

Job Description

At AstraZeneca, we are dedicated to improving the lives of patients worldwide through innovative and high-quality medicines. As an Associate Director of Regulatory Affairs - CMC, you will play a critical role in ensuring the successful development, registration, and commercialization of our pharmaceutical products. With your expertise in regulatory affairs and CMC (Chemistry, Manufacturing, and Controls), you will help to shape and execute our global regulatory strategies, ensuring compliance with all relevant regulations and guidelines. This is an exciting opportunity for a driven and detail-oriented professional to join our dynamic and collaborative team. If you have a strong background in regulatory affairs, CMC, and a passion for improving patients' lives, we encourage you to apply.

Develop and execute global regulatory strategies for pharmaceutical products in alignment with company goals and objectives.
Ensure compliance with all relevant regulations, guidelines, and standards for CMC aspects of drug development, registration, and commercialization.
Monitor and assess changes in regulatory requirements and communicate potential impact to relevant stakeholders.
Serve as a subject matter expert on CMC related regulatory requirements and provide guidance to cross-functional teams.
Manage the preparation, review, and submission of high-quality regulatory submissions to health authorities.
Collaborate with internal and external stakeholders to ensure timely and successful approvals for new products and variations.
Provide regulatory support and guidance throughout the product lifecycle, including post-approval changes and regulatory inspections.
Lead and participate in regulatory meetings with health authorities to discuss CMC related topics.
Keep abreast of emerging trends and best practices in regulatory affairs and CMC, and incorporate them into the company's processes and procedures.
Mentor and train junior regulatory affairs team members on CMC related topics.
Collaborate with cross-functional teams to ensure CMC related activities are aligned with overall project timelines and goals.
Participate in risk assessments and develop risk mitigation strategies related to CMC aspects of drug development and registration.
Represent the company in external forums and conferences related to regulatory affairs and CMC.
Continuously evaluate and improve processes and procedures related to CMC regulatory affairs to ensure compliance and efficiency.
Uphold the company's values and standards of ethics and integrity in all interactions and activities.

Where is this job?

This job is located at Santa Monica, CA, USA

Job Qualifications

Strong Knowledge Of Regulatory Guidelines And Requirements: The Successful Candidate Should Have A Deep Understanding Of The Regulatory Landscape, Including Fda Regulations, Ich Guidelines, And Other Relevant Regulatory Bodies. This Knowledge Will Be Essential In Developing And Implementing Cmc Strategies That Are In Compliance With Current Regulations.
Experience With Cmc Submissions And Approvals: The Associate Director Should Have A Proven Track Record Of Successful Cmc Submissions And Approvals For Pharmaceutical Products. This Includes Experience With Inds, Ndas, And Other Relevant Regulatory Submissions.
Leadership And Project Management Skills: As An Associate Director, This Individual Will Be Responsible For Leading A Team And Managing Multiple Projects Simultaneously. Strong Leadership And Project Management Skills Are Necessary To Ensure Timely And Successful Completion Of Cmc Activities.
Technical Expertise In Cmc: This Role Requires A Deep Understanding Of Cmc Activities, Including Drug Development, Manufacturing Processes, Analytical Methods, And Quality Control. The Ideal Candidate Should Have A Strong Technical Background In Chemistry, Pharmacy, Or A Related Field.
Communication And Collaboration Skills: The Associate Director Will Be Expected To Communicate And Collaborate With Various Internal And External Stakeholders, Including Cross-Functional Teams, Regulatory Agencies, And External Partners. Excellent Communication And Collaboration Skills Are Critical For This Role To Ensure Alignment And Compliance With Regulatory Requirements.

Required Skills

Project Management
Technical Writing
Quality Control
Team Leadership
Risk assessment
Regulatory compliance
FDA regulations
Regulatory Submissions
Pharmaceutical Industry
Gmp Standards
Cmc Strategies

Soft Skills

Communication
Leadership
Time management
Interpersonal Skills
creativity
flexibility
Organizational skills
Teamwork
Adaptability
Problem-Solving

Compensation

According to JobzMall, the average salary range for a Associate Director, Regulatory Affairs - CMC in Santa Monica, CA, USA is $120,000 - $200,000 per year. This can vary depending on factors such as experience, education, and the specific company and industry the individual is working in.

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 BeforeMay 10th, 2026

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