Biologics Operations Submission Manager
Are you looking for an opportunity to make a significant impact in the pharmaceutical industry? Look no further than AstraZeneca! We are currently seeking a highly motivated and skilled Biologics Operations Submission Manager to join our team. In this role, you will play a crucial role in the development and submission of biologic products that have the potential to positively impact the lives of patients around the world. If you have a passion for driving excellence and have a strong understanding of regulatory requirements, we want to hear from you. Join us at AstraZeneca and help us make a difference in the lives of patients.
- Develop and implement strategies for the successful submission of biologic products to regulatory agencies.
- Ensure compliance with all relevant regulatory requirements and guidelines.
- Collaborate with cross-functional teams to drive the development and submission of high-quality biologic products.
- Manage timelines and resources to ensure timely submission of biologic products.
- Review and analyze data to ensure accuracy and completeness of submission materials.
- Establish and maintain relationships with regulatory agencies to facilitate efficient and effective submissions.
- Provide guidance and support to internal teams regarding regulatory requirements and submission processes.
- Develop and maintain standard operating procedures for submission processes.
- Stay updated on industry trends and changes in regulatory requirements to ensure submission materials are in compliance.
- Identify and mitigate potential submission risks to ensure successful approval of biologic products.
- Communicate submission status and progress to stakeholders and senior management.
- Train and mentor junior team members on submission processes and regulatory requirements.
- Contribute to continuous improvement initiatives to enhance submission processes and increase efficiency.
- Represent AstraZeneca at industry conferences and events to promote the company's expertise in biologic submissions.
- Uphold AstraZeneca's values and standards of ethics and compliance in all job duties.
Bachelor's Degree In A Relevant Scientific Field (E.g. Biology, Biochemistry, Pharmaceuticals)
Minimum Of 5 Years Of Experience In Regulatory Affairs Within The Biopharmaceutical Industry
Strong Knowledge Of Global Regulatory Requirements And Guidelines For Biologics
Experience In Managing And Coordinating Regulatory Submissions For Biologic Products
Excellent Communication And Project Management Skills, With The Ability To Work Cross-Functionally And With External Partners.
Quality Assurance
Communication Skills
Project Management
Data Analysis
GMP Knowledge
Technical Writing
Document management
Regulatory compliance
FDA regulations
Cross-Functional Collaboration
Submission Strategy
Communication
Emotional Intelligence
Leadership
Time management
Interpersonal Skills
creativity
Teamwork
collaboration
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Biologics Operations Submission Manager in Gaithersburg, MD, USA is $80,000-$120,000 per year. However, salaries can vary depending on factors such as experience, qualifications, and the specific company or organization. It is always best to research the salary range for a specific job position and company before applying for a job.
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AstraZeneca plc is a British-Swedish multinational pharmaceutical and biopharmaceutical company.
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