Regulatory Affairs CMC Manager - Central London

Recruiter
inVentiv Health Clinical
Location
London (Greater)
Salary
£1 - £300 000
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Contract
Hours
Full Time
EZ/6256

Regulatory Affairs CMC Manager

Central London

Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You'll work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA.

Here at INC Research inVentiv Health we are currently recruiting for Regulatory Affairs CMC Manager to work fully embedded with our pharmaceutical sponsor based in central London.

This role can be offered either as a 12 months fixed term or as a freelance contract.

Regulatory Affairs Manager works with US based project teams and subject matter experts on the life-cycle management of biological protein medicinal products in EU and Switzerland to ensure compliance. The role involves working closely with in-house CMC teams, partners, contract manufacturing organizations, and global health authorities to ensure rapid review and approval of the CMC portions of marketing applications, supplements/ variations, clinical trial applications and other CMC-oriented filings. Expertise with biologics is strongly preferred. CMC regulatory expertise with biologics is essential.

Responsibilities:

For assigned protein medicinal compounds the candidate will be responsible for:

- The assessment of manufacturing changes.
- The planning and execution of variation submissions and responses to questions work with subject matter experts, as required.
- The management and communication of review outcomes to impacted stakeholders.
- Respond to general queries related to EU post approval guidelines.

Requirements:

- Collaborative, knowledgeable, organized, good and consistent communicator with attention to detail.
- Proven time management skills and the ability to prioritize tasks.
- Candidate should demonstrate initiative and the ability to work independently. Also must have proven ability to work as part of a cross functional/cultural team.
- Degree in Life Science, Post grad qualifications desirable.
- Knowledge of the manufacturing of biological medicinal products with proven relevant EU CMC Regulatory Affairs experience.
- Solid experience in lifecycle management of biological medicinal products with exhibited knowledge and proficiency in EU CMC Regulatory Affairs.
- Extensive knowledge and experience of EU CMC Reg Affairs guidelines and regulation of post approval changes for biological medicinal products Change control assessment Variation/lifecycle submission authoring, reviewing and management

Application Details:
If you have the required experience for this position and are eligible to work in the UK then please apply below or contact Ellie Zavrelova on ******************

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