AstraZeneca Chemistry/Pharma CMC Associate Vacancy
Dont forget to check out possible interview questions for this job below
AstraZeneca invites candidates with experience in msc chemistry for the post of CMC RA Associate. Chemistry job opening 2023, MSc chemistry job opening 2023, Regional CMC RA Associate post vacancy 2023. Intrested and eligible candidates may check out all the detail
Job Title: CMC RA Associate I Submission Excellence & Project Management
Location: India – Bangalore
CAREER LEVEL: C
Lead the way for a new breed of solutions-oriented Regulators
- Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get involved in shaping drug development
- Be part of the team where you are empowered to follow the science
- Be part of the solution, turning our drug development strategies into reality. Work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need and healthcare professionals..
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 relevantexperience
Team working skills
- IT Skills
- Professional capabilities: Regulatory knowledge
- 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
- Lean Approach
- Quality Risk Management
Job Responsibilities (to include key result areas, specific accountabilities, tasks, etc.)
- 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, 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
Important Interview Questions and Answers for the above job role
- What is your educational background and work experience in the biopharmaceutical industry?
Answers: I have a degree in Chemistry and have been working in the biopharmaceutical industry for 4 years, mainly in regulatory affairs.
2. Can you tell us about your experience in regulatory affairs and your knowledge of current CMC requirements?
Answers: I have worked on the preparation and submission of regulatory documents and have a good understanding of current CMC requirements. I keep myself updated with regulatory guidelines and requirements.
3. How do you ensure compliance with global health authority regulations and guidelines when preparing regulatory documents?
Answers: I follow a detailed process of checking and verifying regulatory documents to ensure compliance with global health authority regulations and guidelines. I work closely with cross-functional project teams to ensure that regulatory requirements are met throughout the drug development process.
4. How do you contribute to the development and improvement of regulatory affairs business processes?
Answers: I keep a track of regulatory commitments, submission requests, and deliverables and provide support and guidance to cross-functional project teams. I also stay up-to-date with regulatory requirements and guidelines and communicate these to project teams and stakeholders as required.
5. Can you give an example of a time when you faced a challenge in regulatory affairs and how you overcame it?
Answers: I faced a challenge in compiling a regulatory submission within a tight deadline. To overcome this challenge, I prioritized tasks and collaborated closely with cross-functional project teams. I also utilized my IT skills to ensure that all submission documents were prepared and submitted to regulatory authorities on time.
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