CMC Document Specialist

Job Title: CMC Document Specialist (Regulatory Affairs)

Location: London

The Client: international speciality pharmaceuticals company delivering high quality medicines

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

The Role:

Main purpose of the role:

Regulatory remediation delivery on multiple product submissions, particularly Quality Overall Summary (QOS) and Module 3 (CMC).

Key Responsibilities:

Coordinate, write and review regulatory dossiers for completion from previous submitted dossiers but for different countries. The products can be in tablet, capsule and injection forms. Cross functional liaison internally and externally with other business units and manufacturers to request information and ensure timely and high quality regulatory documents and submission.

Full details available on application

The Candidate:

•A minimum of 2 years experience in regulatory CMC within the pharmaceutical industry in regulated markets. Have written a number of CTD's including pharmaceutical development reports and ideally Quality Overall Summaries (pharmaceutical Expert Reports) for regulatory submissions.
•Excellent technical knowledge of all solid, semi-solid & liquid pharmaceutical dosage forms including sterile products. Has comprehensive understanding of formulation and manufacturing changes on quality, clinical and pharmacokinetic parameters. Thorough knowledge of API issues affecting product quality
•Able to summarise complex technical, manufacturing and quality information and data into easily understood conclusions.
•Understands overall submission structure and inter-relationships between Modules 1 to 5.
•Approaches work with a sense of urgency and can meet tight deadlines. Is able to work with multiple projects at the same time.
•Excellent grasp and use of grammatically correct written English. Good communication skills.
•Proficient of all MS Office applications, Adobe Acrobat, and web applications.
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

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