Hobson Prior are looking for an Operations Regulatory CMC (Analyst) to join a world-wide biopharmaceutical organisation whose pioneering medicines are used by people all over the world. This is a contract position, located in Macclesfield.

Job Responsibilities:

• You will coordinate the assembly, including document requests and generation, of submission-ready components to support lifecycle submissions linked to license maintenance and post approval changes.
• Support the timely delivery and submission of post approval CMC documentation to marketing companies and health authorities.
• Review and approve regulatory CMC documents on behalf of Operations Regulatory.
• Co-operate with stakeholders across Operations (including technical functions and manufacturing sites) and Global Regulatory Affairs.
• Advise on CMC regulatory and compliance focussed aspects of post-approval regulatory submissions.
• Support the progression and delivery of cross-functional documentation required by Global Regulatory Affairs for inclusion in worldwide regulatory submissions.
• Share knowledge and learnings gained from own projects with colleagues within and outside the department as appropriate.
• Maintenance of electronic systems to ensure the current regulatory submission and commitment status is accurately reflected, notifying relevant departments and groups of health authority approvals as they are received.

Key Skills:

• IT skills.
• Excellent written and spoken English.
• Team working skills.
• Influencing skills.
• Delivery focus with ability to effectively manage projects.
• Attention to Detail.

Requirements:

• Graduate in a scientific discipline e.g. chemistry, pharmacy or biological science or at least 4 years' experience in a Regulatory Affairs, Quality Assurance or Research and Development role linked to the Pharmaceutical industry.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.