A well established, prestigious, multinational pharmaceutical company based in Hertfordshire. They specialise in Oncology, CNS and and Gastro-Intestinal Medicine. As the Senior Manager of Regulatory Affairs you will have considerable opportunities for growth.
This position is a fixed term contract for a period of 12 months to work form this companies state of the art European Headquarters in Historical Hertfordshire.
The focus of this role is to achieve two aims including:
- Responsibility for clinical trial submissions, scientific advice, and regulatory input into clinical and drug development plans for all assigned developmental and marketed compounds.
- Assist in managing MAA submissions for compounds allocated as well as new pipeline projects and late stage candidates brought in through in-licensing.
On a day to day basis your will be responsible for:
- Supporting regulatory strategy and manages timelines and resources to meet project needs
- Taking responsibility for the quality and completeness of regulatory submissions for Clinical Trial Applications, amendments updates etc. for NCEs and MAAs
- Accountability for overall quality and compliance of regulatory submission documents to the appropriate regulatory bodies and acts as the day to day contact point with regulatory authorities for communications relating to proposed/pending clinical trial application.
- Providing input into clinical and drug development plans for projects allocated
- Providing regulatory input and project management for all variations for projects allocated
- Working closely with your colleagues to ensure that the EU regulatory strategy is addressed and any required submissions are made within the specified timeframes
- Organising Regulatory Agency meetings and accompanying briefing documents in accordance with project requirements
- Working closely with your colleagues as well as CROs and Partner companies to ensure that correct and complete submissions are made within agreed timeframes
- Providing EU regulatory input into IPTs for the projects allocated
- Influencing regulatory related work processes that span across multiple teams, functions or departments
- Taking the lead in interacting with external stakeholders regarding regulatory issues
- Managing multiple resources within and across groups to meet project deliverables with regard to regulatory requirements
- Understanding the strengths and weaknesses of the team and plans to get the highest and best use of team members
- Leading problem solving: facilitating team(s) to identify issues and propose solutions with respect to regulatory issues
- Assists in resource allocation as needed
If you believe that you can make an impact on this cutting edge business please send through your CV.
CK Regulatory Statement
By working with CK Regulatory (part of the CK Clinical group) you can take advantage of our large network of contacts built upon our reputation of honesty and integrity.
We will be pro-active on your behalf to introduce you to the right people in the right places.
CK Regulatory can offer Careers advice, help with writing your CV, assistance with your interview preparation and up to date information about the industry.
For an informal chat call Jonathan on Tel No. 01438 743047 or Email jhartsmith@ckclinical.co.uk.
All enquiries will be met with complete discretion.
Keywords: Regulatory Affairs, Reg Affairs, MAA, CTA, Senior Regulatory Affairs, Senior Reg Affairs, Hertfordshire, Regulatory Affairs jobs, Regulatory Affairs job
