Pharmaceutical Regulatory Expert

3 weeks ago


Cambridge, Cambridgeshire, United Kingdom Dr. Reddy's Laboratories Full time

Job Overview: We are seeking an experienced Regulatory Affairs Manager to join our team in Cambridge, UK.

About the Company:

Dr. Reddy's Laboratories is a global pharmaceutical company with a presence in over 30 countries.

We prioritize innovation, quality, and patient-centricity in everything we do.

Key Responsibilities:

  1. Preparation and submission of MAA procedures, including national and IRP processes.
  2. Maintenance of relationships with regulatory authorities, European affiliates, and internal contacts.
  3. Review and assessment of registration dossiers prior to submission.
  4. Support of product launch activities.
  5. Other regulatory related tasks such as variations for manufacturing licenses and PIL uploads.

Requirements and Qualifications:

  • Study / Degree in Pharmaceutical Sciences, Life Sciences or Natural Sciences with at least three years' experience in EU Regulatory Affairs.
  • Fluent English language skills are mandatory.
  • Experience with eCTD and LORENZ docuBridge publishing is required.
  • Experience with MHRA is recommended.
  • Digital savvy with good knowledge of MS Office and RA-related software.

Benefits:

  • Ongoing training and development opportunities.
  • A collaborative and dynamic work environment.
  • The chance to work on exciting projects that make a real difference.

Salary: £55,000 - £70,000 per annum, depending on experience.



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