AstraZeneca Biological Sciences RA Associate Job Opening, Apply Online
AstraZeneca Biological Sciences RA Associate Job Opening, Apply Online. Latest position as RA Associate in Astra Zeneca, Interested and eligible candidates can check put al the details given the same below.
Possible Interview Questions are posted below:
CMC RA Associate I Submission Excellence & Project Management.
Job Location: India – Bangalore
Job ID: R-173680
ABOUT ASTRAZENECA
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca we’re dedicated to being a Great Place to Work.
Brief Job Description:
The CMC RA Associate is responsible for providing support in the collection, evaluation, preparation, and assembly of Chemistry, Manufacturing and Control (CMC) documentation required for submissions to support both original marketing applications and maintenance of existing licenses for marketed products including post approval submissions. Part of a dynamic team that works closely with relevant product and project teams providing regulatory and compliance advice as appropriate. The role holder will ensure the application of global CMC regulations and guidance within AstraZeneca and contribute to
updates of policy and processes as appropriate.Job Responsibilities:
- Assist in the preparation of regulatory submissions, including formatting and compilation of submission documentation, and preparation of regulatory components.
- Support and delivery of submission ready packages to agreed timelines and management of information required.
- Responsible for upload, retrieval, and maintenance of documents for electronic submissions using the appropriate software and applications.
- Ensure maintenance and filing of regulatory related documentation and track regulatory commitments, submission requests, and deliverables.
- Develop research skills relevant information, regulations, and guidance from different regulatory agencies.
- Interact with cross-functional groups and attend team meetings as necessary to support submission development and project coordination.
- Assist in the preparation of agendas, presentations, and other supporting materials for various meetings.
- Contribute to the development and improvement of related business processes.
- Review submission documentation for accuracy and compliance with applicable regulations and guidelines as required.
- Ensure the learning from own projects are shared with other colleagues/within the functions.
Typical Accountabilities (per AZ framework and regulatory expectations):
- Conduct activities and interactions consistent with Company Values and in compliance with the Code of Ethics and supporting Policies and Standards relevant to your role (including SHE). Complete all required training on the AZ Code of Ethics and supporting Policies and Standards on time. Report potential issues of non-compliance.
- AstraZeneca drives business performance through continuous improvement, we therefore expect all employees to 1)Follow processes and work to standards. 2)Identify and solve problems 3) Define and implement improvements. Leaders will lead by example in creating a learning & continuous improvement culture.
Education, Qualifications, Skills and Experience
Essential
- Educated to degree level /equivalent experience in a scientific discipline eg chemistry, pharmacy or biological science
- Minimum 4 years of Relevant experience from biopharmaceutical industry, or other relevant experience
- Team working skills
- IT Skills
- Self-motivated
- Professional capabilities: Regulatory knowledge.
Desirable
- Basic Knowledge of the drug development process and regulatory submissions
- Understanding of current regulatory CMC requirements.
- Experience in Pharmaceutical production , reg affairs, quality assurance, R&D.
- Basic Understanding of regulations and guidance governing the manufacture of biotechnology products, especially monoclonal antibodies.
- Professional Capabilities.
- Lean Approach.
- Quality Risk Management.
Key Relationships to reach solutions
Internal (to AZ or team)
- Global Regulatory Affairs
- China Regulatory Affairs Regulatory Groups
- Manufacturing Site Quality Groups
- Global Supply Chain & Strategy
- Biopharmaceutical Development
- Pharmaceutical Development
- Marketing Company
Possible Interview Questions:
- Can you explain the role of a CMC RA Associate in the context of regulatory submissions and compliance within the biopharmaceutical industry?
- The role of a CMC RA Associate is to provide support in the collection, evaluation, preparation, and assembly of CMC documentation for regulatory submissions. They ensure compliance with global CMC regulations, contribute to policy updates, and provide regulatory advice to product and project teams.
- How do you ensure the accuracy and compliance of submission documentation with applicable regulations and guidelines?
- I review submission documentation meticulously, ensuring it aligns with the relevant regulations and guidelines. I verify the accuracy of information, check for completeness, and cross-reference it with the required documentation. If any gaps or non-compliance are identified, I collaborate with the relevant stakeholders to address and rectify them.
- Can you describe your experience in managing submission timelines and handling the information required for submission-ready packages?
- In my previous role, I was responsible for supporting and delivering submission-ready packages within agreed timelines. I ensured proper coordination and communication with cross-functional teams to gather the necessary information. I maintained a systematic approach, tracking and organizing the required documents to meet submission deadlines effectively.
- How do you stay updated on regulatory requirements and guidance from different regulatory agencies?
- I am committed to continuous learning and staying informed about regulatory developments. I regularly monitor regulatory agency websites, attend relevant seminars and conferences, and subscribe to industry publications and newsletters. This helps me stay abreast of the latest regulatory requirements and guidance to ensure compliance in my work.
- Can you provide an example of a situation where you contributed to the improvement of business processes related to regulatory affairs?
- In my previous role, I identified an opportunity to streamline the document management system for regulatory submissions. I proposed the implementation of a new software tool that enhanced efficiency, facilitated document tracking, and improved collaboration among team members. This resulted in a significant reduction in time spent on document handling and improved overall productivity.
These sample answers provide a starting point and can be tailored based on the candidate’s specific experiences and achievements.
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