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Regulatory Affairs Manager CMC (Contract)

Eingestellt von Apex International

Gesuchte Skills: Support, Product lifecycle management

Projektbeschreibung

Job Title: Regulatory Affairs Manager CMC (Contract)

Location: Berkshire

Duration: ASAP - the end of 2015 with a view to extend

The Client: Global Pharma company

Benefits: Competitive hourly rate available - Full details available on application

The Role:

Perform CMC gap analysis comparing registered dossiers with current manufacturing site practice and regulatory expectations
Compare the batch manufacturing records, product specification, analytical methods used to that what is registered in the MA.
Check the variation history on changes registered and include the above mentioned comparison
Check on raw material grades and suppliers used in MA relative to that used by manufacturing
Compile the gap analysis in a template
Identify the required documentation for CMC submissions and negotiate the delivery of approved technical source data and documents in accordance with project timelines
Prepare and review CMC responses to health authority questions during development, registration and product lifecycle
Work with R&D, Quality and other regulatory colleagues to ensure documentation meets EMEA CMC regulatory requirements
Write high-quality CMC documents to support product maintenance activities
Provide advice on CMC regulatory strategies
Create supporting documentation to ensure successful product lifecycle management

Full details available on application

The Candidate:

The ideal candidate will be a regulatory affairs professional with significant CMC experience and familiarity with relevant regulatory guidance.
The candidate will be able to use their regulatory expertise and problem-solving capabilities to support the maintenance of a wide portfolio of products.
The candidate will have a life sciences degree, or equivalent, together with a number of years experience of hands-on European regulatory activities within a pharmaceutical company (including 7+ years CMC regulatory experience).
The ideal candidate will also have excellent interpersonal, verbal and written skills and have the ability to provide CMC regulatory support to different functional areas (e.g., Quality, R&D, Supply Chain) as required.

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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Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Apex International