Company: Regulatory Professionals
Closing Date: 05 Jan 17
Salary (£): On Application
Regulatory Affairs CMC Contractor - Excellent hourly rate: Hertfordshire Rate: Dependant on experience: 6 months •Would you like to work for a Global Pharmaceutical business who is heavily expanded into Emerging Markets and ROW Countries?
Regulatory Affairs CMC Contractor - Hertfordshire - Excellent hourly rate
Rate: Dependant on experience
Duration: 6 months
*Would you like to work for a Global Pharmaceutical business who is heavily expanded into Emerging Markets and ROW Countries?
*Are you an expert in CMC?
*Do you have knowledge of the development of solid, liquid and parenteral dosage forms, including process validation?
Your next employer:
Our client is one of the world"e;s leading research-based pharmaceutical companies with operations in Europe, US and Asia. Due to recent developments and expansion into the Emerging Markets our client has a number of vacancies within Regulatory Affairs. Based in Hertfordshire and operating in a very flat operational structure, you will have the opportunity to work with a variety of Senior Management including the CEO. This means that hard work and good results are quickly recognised.
Your next position:
As the successful Regulatory Affairs Contractor / Regulatory CMC Consultant you will:
* Support a manufacturing compliance project for our clients products with specific product responsibilities.
* Support compilation of submission documents (Module 3 for MAAs or licence variations) and responds to questions from health authorities.
* Have accountability for the quality of any submission.
* Guide the Global Regulatory Affairs CMC group as a member of staff.
The Regulatory Affairs CMC Consultant / Regulatory Affairs Contractor will carry out the following duties:
* Accountable for the quality and compliance of CMC aspects of projects/products objectives and submissions made by Global Regulatory CMC.
* For assigned topics review regulatory correspondence to determine current regulatory CMC status. Highlight any inconsistencies within and between Module 3 leafs, and areas of non-compliance.
* Provides oversight for the CMC components of all regulatory submissions (MAAs particularly in emerging markets, variations, agency 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 section of submissions.
* Leads effective responses to Health Agency CMC questions.
* Interacts with and influences internal stake holders.
* To be a main contact point within our clients EU as well as US, for communications relating to Quality/CMC issues.
* Supports regulatory strategy and manages timelines to meet project needs.
* Interacts with external stakeholders regarding CMC regulatory issues.
Keywords: Regulatory Affairs, CMC, Module 3, Compliance, Hertfordshire, Herts, Watford, M25, Chemical Manufacturing Control, Freelance, Contract, Day rate, hourly rate, Regulatory Affairs Consultant, Regulatory Affairs Contractor, Emerging Markets, MENA, ASIAPAC, EU, ROW, US, Japan, ASIA, ASPAC, EMEA
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