- Manage regulatory documents, including uploading and tracking files and systems as per AstraZeneca procedures and regulatory requirements.
- Maintain documentation and records in the Veeva RIM system according to defined standards and processes.
- Plan, prepare, and execute simple submissions and assist with the preparation and planning of regulatory dispatches.
- Interface with Health Authority (HA) systems for designated regulatory tasks.
Essential Skills/Experience:
- Relevant qualification and/or experience in science.
- Regulatory experience from the biopharmaceutical industry or related field.
- Some regulatory, medical, or technical experience.
- Knowledge of AstraZeneca business processes, submissions, compilation, publishing, and approval processes.
- Strong written and verbal communication skills.
- Experience working with international teams.
- Good commercial and product awareness.
- Strong IT/IS skills.
- Project planning and organizational skills with a focus on delivery and results.
- Flexibility, adaptability, and strong interpersonal and networking skills.
- Ability to work independently and in a team.
- Proactive problem-solving skills.
Work Environment:
- AstraZeneca values in-person collaboration, working a minimum of three days per week from the office while respecting individual flexibility.
- We aim to translate our drug development strategies into reality through all development stages to achieve the best results for AstraZeneca, patients, and healthcare professionals.
- Our team is diverse, open-minded, and committed to exploring new ideas and innovations.