Senior Manager CMC Regulatory Affairs - Hertfordshire

CK Clinical
09 Mar 2018
15 Mar 2018
Contract Type
Full Time
Mary Bolt is recruiting for a Senior Manager CMC Regulatory Affairs to join a global pharmaceutical company committed to contributing to better healthcare at their site based in Hertfordshire on a permanent basis.

The main purpose of the role will be to:
- Guide the CMC-regulatory group as a member of staff, envisage the pharmaceutical industry environment and prepare for the future risks from a CMC-regulatory perspective and lead the preparation of submission documents (IMPD-Q, Module 3 for MAA or license variations and provide response to questions from health authorities in a timely manner).
- Assume regulatory accountability for the CMC aspects of the projects/products goals and objectives and provide oversight for the CMC components of all regulatory submissions (IND or CTA, NDA or MAA, amendments, variations, scientific advice briefing documents, CMC agency communications etc.) to ensure that quality documents are prepared in compliance with the applicable regulatory requirements.
- Engage in or lead CMC sub-teams to plan, prepare and complete the CMC sections of major submissions.

Further responsibilities will include:
-Leading effective responses to Health Agency CMC questions and engaging in regional/national health agency meetings for CMC related discussions.
-Being accountable for the quality and compliance of CMC aspects of all submissions and acting as a main contact point within the group for communications relating to Quality/CMC issues.
-Supporting regulatory strategy and managing timelines to meet project needs as well as interacting with and influencing external stakeholders.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
-Educated to degree level or above in life science or a related field with extensive experience of working within CMC in Regulatory Affairs.
-An accomplished working knowledge of both the formulation and analytical aspects of R&D and experience of dealing with agencies, preparation of briefing documents and holding agency meetings relating to Quality issues.
-The Ability to express a scientific opinion clearly and concisely and to defend regulatory decisions under pressure as well as high organisational and time management skills and the ability to manage multiple projects and multiple tasks.

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

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 campaign. Entitlement to work in the EEA is essential. Please quote reference CL41427 in all correspondence.

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