CMC Regulatory - Senior Manager

4 days left

GI Group
Hertfordshire, Hatfield, England
20 Apr 2021
20 May 2021
Claire Paas
Regulatory Affairs
Full Time
Contract Type
Experience Level
Senior Management

CMC Regulatory - Senior Manager
Competitive Salary

Exciting opportunity to work for our International pharmaceutical client, who is looking for an experienced Manager to provide CMC-regulatory services to support success worldwide. You will be accountable for the execution of multiple projects and stakeholder's satisfaction. Collaborates with other teams supporting development projects towards licence submission and approval and provide CMC-regulatory support for established products including growth market submissions and any post-approval activities relevant to the drug substance and/or drug product.

Main duties and responsibilities:

* Ensures quality of deliverables and services to stakeholders for multiple projects/product.
* Take measures to keep development projects and established product away from regulatory risk.
* Provide CMC-regulatory advice to project members.
* Have a good knowledge of quality guidelines and how to apply them.
* Establish CMC-regulatory strategy for projects/products.
* Lead preparation of CMC-regulatory documents.
* Attend CMC-regulatory meetings to solve issues on CMC/Quality for development or marketed projects.
* Review changes proposed by QA/manufacturing and take any necessary CMC-regulatory actions to implement the changes.
* Liaise with affiliates/distributors in new markets on CMC-regulatory issues.
* Evaluate CMC-regulatory processes and propose solutions to improve CMC-regulatory activities.

Skills & Experience required:

* Previous CMC-regulatory related experience plus additional related experience (i.e., in Research and Development or Manufacturing, Quality Assurance, Quality Control etc.),
* Possess working knowledge on the formulation and/or analytical aspects of R&D in addition to the above CMC-regulatory related experience
* A working knowledge on the principles of chemistry/biochemistry to drug substance manufacture
* Experience in the development of solid and/or parenteral dosage forms, including process validation.
* Experience dealing with agencies, preparation of briefing documents and holding agency meetings relating to CMC/Quality issues.
* College or University degree in an associated functional discipline (Chemistry, Biological Science or Pharmacy)
* Doctorate or higher degree desired (e.g. MSc, JD, Pharm D, or PhD in life sciences)
* Ability to express a scientific opinion clearly and concisely. Able to defend CMC-regulatory advice under pressure.

If you are interested in this role and feel that you have the right skills then please click apply.

For further details, please contact us on 01707 247259

Gi Group Pharmaceuticals provides a tailored Account Managed Service and dedicated Pharmaceutical recruitment team and partners with many different Pharmaceutical and Biotechnology clients throughout the globe and the United Kingdom.

Gi Group Holdings Recruitment Limited group of companies includes Gi Recruitment Limited, Draefern Limited, Gi Group Recruitment Ltd, INTOO (UK) Limited, Marks Sattin (UK) Limited, TACK TMI UK Limited and Grafton Professional Staffing Limited. We are committed to protecting the privacy of all of our candidates and clients. Following some recent changes to data protection laws we have updated our Privacy Policy. To view a copy and to help you understand how we collect, use and process your personal data please visit the Privacy page on our Gi Group UK website.

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