Pharmaceutical Regulatory Expert
3 weeks ago
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:
- Preparation and submission of MAA procedures, including national and IRP processes.
- Maintenance of relationships with regulatory authorities, European affiliates, and internal contacts.
- Review and assessment of registration dossiers prior to submission.
- Support of product launch activities.
- 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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