Hobson Prior currently have an opportunity for a Senior CMC Documentation Lead to join a Regulatory Documentation Team at a research-based biopharmaceutical organisation, who are focused on developing pioneering medicines to make a positive impact on patients' lives.

Job Responsibilities:

• Responsible within Pharmaceutical Development for the production and delivery of CMC sections of all regulatory documents (e.g. marketing and clinical study applications, responses to Health Authority questions and briefing documents).
• Lead the review process for all CMC documents, consolidating all comments.
• Define which CMC documents are required.
• You will prepare for and run the CMC Submission Kick Off meeting.
• Lead the delivery team (authors, reviewers, approvers) for the CMC part of submissions.
• Accountable to drive the completion and on-time approval of all CMC documents to submission ready standards.

Key Skills:

• Demonstrated strong interpersonal, motivational and leadership skills.
• Independent and calm under pressure.
• Confident leader and a clear communicator at ease of communicating with senior leaders.
• Results-focus and ability to deliver projects.
• Ability to set and manage priorities, resources, goals and project initiatives.
• Strong written and verbal in English.

Requirements:

• A University degree or equivalent experience, preferably Chemistry or Pharmacy.
• Proven experience working in a science area with the drug development process involving regulatory documentation using Document Management Systems, e.g., ANGEL.
• A strong understanding of the pharmaceutical industry, drug development process, AZ departments and how they contribute to AZ processes to fulfill regulatory requirements.
• Evidence of acting decisively, collaborative working, strategic leadership, commitment to customers and integrity, driving accountabilities with people at all levels and within drug product delivery teams.

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.