Regulatory Affairs Officer

3 days ago

Maidenhead, United Kingdom Noumed Life Sciences Full time

Noumed Life Sciences is an expanding pharmaceutical company based in Maidenhead, Berkshire focusing on cGMP, solid dosage generic pharmaceuticals. We offer a generous pension scheme, 23 days holiday, ample free parking, and an onsite gym.

Due to significant growth across the business, we are looking for a Regulatory Affairs professional with moderate experience in industry to join a expanding Regulatory department. You will assist in regulatory submission and publishing activities of department projects.

**About the role**:
Duties inclusive but not limited to the below;
- Compilation and maintaining Product licence files.
- Co-ordinate regulatory activities with QPPV and QP (Quality/GMP) for management of MAs.
- Process and communicate regulatory approvals internally and to external stake holders.
- Participate to the review of process/product changes, deviations, product complaints, adverse drug reactions, medical information and batch recall to determine the need for any regulatory activities and to ensure compliance to regulatory requirements;
- Maintain regulatory files/database and chronologies in good order. Maintain system for tracking changes in documents submitted to agencies or partners.
- Compile and submit variations

**About you**:

- Pharmacy/Chemistry degree
- 1-2 years Regulatory Affairs experience
- Understanding of the current UK and European regulations, laws, guidelines and industry requirements.
- Exposure to NeeS/eCTD format and electronic submission gateways is preferable.
- Experience with Generic products and MRP/DCP submissions is advantageous.

Please note that as a manufacturing site, we are unable to offer hybrid working.

**Job Types**: Full-time, Permanent

**Salary**: £28,000.00-£32,000.00 per year

**Benefits**:

- Company pension
- Cycle to work scheme
- Free parking
- Gym membership
- On-site parking

Schedule:

- Monday to Friday

Work authorisation:

- United Kingdom (required)

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