Regulatory Affairs Officer

2 weeks ago

Maidenhead, United Kingdom Noumed Life Sciences Full time

**Please note that this role is site based at our Manufacturing Plant in Maidenhead**

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.

**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)

Work Location: One location

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