Regulatory Affairs Officer

Nitro.bg; Birmingham; On-site; GBP 30,000; Full time

Job summary

A leading pharmaceutical company in Birmingham is seeking a full-time Regulatory Officer. The role involves ensuring compliance with GDP and GMP directives while managing product registrations and variations. Suitable candidates will have experience in the pharmaceutical industry. The position offers a salary of £30,000 along with 25 days of holiday plus Bank Holidays.

Benefits

Basic Salary of £30,000

25 days holidays plus Bank Holidays

Qualifications

• Experience working to GDP and/or GMP directives.
• Background in the pharmaceutical industry is desirable.

Responsibilities

• Prepare PLPI/initial applications.
• Respond to RFIs.
• Handle pharmaceutical/admin variations.
• Manage PIL variations.
• Process renewals.
• Register products on AMF.
• Allocate barcodes via GS1 for products.
• Book in samples.
• Send coded leaflets and cartons to production.
• Maintain departmental databases.
• Communicate effectively with MHRA assessors.

Skills

Complying with GDP and GMP directives

Maintaining databases

Communication with assessors

Job description

Overview

McAllister Recruitment are recruiting for our client a leading company in the Pharmaceutical Import/export industry. This is an opportunity to work with a well established pharmaceutical business.

This position would suit someone with a Quality or Regulatory background in the pharmaceutical industry.

This is a full-time position, based in the Birmingham area. The hours are Monday to Thursday 8 am to 5 pm and Friday 8 am to 12.00 pm.

What Our Client Can Offer You

• Basic Salary of £30,000
• Holidays 25 days plus Bank Holidays

Industry

Pharmaceuticals, Import/Export

Role

As a Regulatory Officer you will be complying with GDP and GMP directives and ensuring accuracy and quality at all times.

Responsibilities

• Preparation Of PLPI/initial applications.
• RFI responses.
• pharmaceutical/admin variations.
• PIL variations.
• Renewals.

Ongoing Tasks

• Registering products on AMF.
• Allocating barcodes via GS1 for products.
• Booking in samples.
• Sending coded leaflets and cartons to production.
• Maintaining departmental databases.
• Maintaining good communication practices with assessors from MHRA.

Experience Requirement

• Working to GDP and or GMP directives

Desirable Experience

• Working in the pharma industry or associated industries

Apply now