Job Description
Vacancy for Regulatory Affairs Associate at AstraZeneca 2023. The Regulatory Affairs Associate I assist other members of Regulatory Affairs Management (RAM) and the Regulatory Therapy Area (TA) in obtaining and maintaining licences and applications in accordance with agreed regulatory strategy and AstraZeneca standards. The Regulatory Affairs Associate I is an individual contributor who applies regulatory domain knowledge and may work under supervision.
| Organization | AstraZeneca |
| Post Name | Regulatory Affairs Associate I |
| Job Location | Bangalore |
| Official Website | https://www.astrazeneca.com/ |
Job Title/Position:
Regulatory Affairs Associate I
Job Overview:
Job vacancy for Pharmacy
Job Location:
Bangalore
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What are the Key Responsibilities?
- Document management including uploading and tracking regulatory files and systems according to established AZ procedures and regulatory requirements
- Planning, preparing and completing simple submissions, and assisting with the preparation and planning of regulatory dispatches
- Be the talk to health authority (HA) and their systems for designated regulatory tasks e.g., management of user fees, receipt of incoming FDA correspondence, ordering EudraCT number, EudraLink support, use of HA portals
- Responsible for the ordering and tracking of specific regulatory requirements such as registration samples, certificates of pharmaceutical products, legal documentation, e.g., letters of authorisation, power of attorney, translations of regulatory documentation
- Provide support across the group for assigned non-drug project roles & responsibilities e.g., function as a designated point of contact or superuser
- Provide guidance and knowledge sharing within the RAM skill group
- If required, support in activities such as scheduling of regulatory submissions, PBRERs, etc.
What are the Educational Qualification(s) for Regulatory Affairs Associate?
Relevant qualification and/or experience in science.
What is the Experience Required for this Job?
Minimum 2 years of experience from biopharmaceutical industry, or other relevant experience.
What are the Preferred Skills required for this Job/Position?
- Proficient verbal and written English
- Project management skills
- Experience in document management and tracking databases.
- Some regulatory/medical/technical experience
- Knowledge of AZ business and processes
- Some knowledge of AZ submissions, compilation, publishing and approval processes, standards, systems and tools
- Experience of collaborating with people from locations outside of India, especially Europe and/or USA.
- Good written and verbal communication skills in English
- Cultural awareness
- Proficiency with common document management tools
- Ability to work independently and as part of a team
- Focus on continuous improvement and knowledge sharing.
Related:
- Vacancy for Scientific Assistant at ACTREC 2023
- Vacancy for Clinical trial Coordinator at JIPMER 2023
- Vacancy for Analyst GRA at Lilly 2023
- Vacancy for Research Assistant at NITRD 2023
- Vacancy for Publications Writer at Pfizer 2023
- Multiple vacancies at National Institute of Epidemiology 2023
- Vacancy for Trainee at GE Healthcare 2023
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