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Position Name :

Regulatory Affairs Associate I

Organization :

AstraZeneca

Qualification:

B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences

Experience:

1 to 2 Years

Salary:

₹ 4,17,783 Per Year

Location:

Bengaluru, Karnataka, India

  • 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.

Application Link

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