Regulatory Officer / Regulatory Affairs Officer - Middlesex

London  ‐ Onsite
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Description

Job Title: Regulatory Officer - Minimum 12 monht rolling contract

Location: Middlesex

The Client: Medium sized pharmaceutical company specializing in the development, licensing and marketing of niche generic medicines and proprietary brands in the UK and across Europe

Benefits: Competitive Salary and benefits available - Full details available on application

The Role:

1. Ensuring that a company's products comply with the regulations of the MHRA.

2. Provides regulatory information, guidance and support to the R&D, Commercial, Clinical and Quality functions with respect to the development of company products.

3. Responsible for the timely management, preparation, submission and follow up of regulatory submissions to Competent Authorities, in whose territories Client wish to operate.

4. Timely management, preparation, submission and follow up of licence variations and renewal approvals.

5. Writing clear, accessible product labels and patient information leaflets.

6. Specifying storage, labelling and packaging requirements.

7. Planning and managing new product development

8. Maintaining quality systems.

9. Ensures regulatory procedures and systems are implemented in order to comply with regulatory requirements and agreed quality standards.

10. Undertaking and managing regulatory inspections.

The Candidate:

1. Minimum qualification of degree in a pharmaceutical science e.g. Pharmacy.

2. Applied EU and ICH guidelines to assess CTD and formulation development documents.

3. Minimum two years experience in formulation development.

4. Assessed and written CTD dossiers.

5. Maintained and updated knowledge of current regulatory guidelines.

6. Experience with submission of variations for different type 1A, 1B and II variations.

7. Experience with submission of renewals

8. Experience with submission of dossiers - national, DCP and MRPs

Application Details:

If your skillset is relevant for this role, please click to apply on the link below. However, if this role doesn't suit your current skill-set, please call Alex on for further advice.

Candidates must provide confirmation that they have valid and existing permission to live and work in the UK.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment process.

About Apex: Apex International are an honest, knowledgeable and niche agency who recruit for the pharmaceutical, biotech and CRO sectors in the UK and EU. We specialise in the areas of: Medical Information, Medical Affairs, Pharmacovigilance, Drug Safety, Regulatory Affairs, Clinical Research, QA & QC, Clinical Data Management, Health Economics, Marketing and Pharmacy (Pharmacists, Pharmacy Technicians and Dispensers). For a confidential and professional chat about your job requirements with an agency who are expert in the fields they recruit for, and for the chance to register for free and receive weekly job updates, please call on or email

Apex International hold Investors in People status and are a corporate member of the Recruitment and Employment Confederation (REC).

Recommend a Friend Reward!!!! If you refer someone who is not currently registered with us and we find them a new position, Apex will repay you with a £200 voucher bonus (of your choice!)

Our Passion - Your Profession - A consultative approach to recruitment.

We match professional candidates to the best permanent, contract and interim roles in the market

Website:

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Start date
n.a
From
Apex International
Published at
20.11.2014
Project ID:
811041
Contract type
Freelance
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