24 August 2022 at 11:24:41
Clinical Development & Operations
POSITION TITLE: Regulatory Lead
REPORT TO: Associate Director RA
DEPARTMENT: Regulatory Affairs
LOCATION: home-based/ possibility to go to office across the UK
A unique CRO who is originally UK-based is looking to grow out their regulatory function globally. Their clients range from smaller biotech's to large global pharmaceutical companies, all with different needs and expectations. They're a small/ mid-size CRO that have huge growth plans and are very successful whilst still maintaining their great working culture and family feel.
This is a brand new role that will join a team of 9 which consists of reg associates, managers and senior managers. The main aim will be to provide Strategic and Operational Regulatory Support in Global; Early Access, Post Trial Access programs and Real World Data studies.
Manage day-to-day regulatory affairs activities to ensure compliance with regulatory obligations and requests
Provide advice on EU regulatory strategy and requirements for investigational and marketed products to pharmaceutical and biotechnology clients
Provide regulatory advice in support of global clinical study programmes with a particular emphasis on identifying areas for harmonisation of regional requirements
Lead/participate in specific projects as directed by the Senior Regulatory Team
Lead/participate in client meetings and liaise with clients regarding ongoing projects
Prepare, coordinate and review documents in order to support regulatory submissions for both investigational and commercial medicinal products
Liaise with regulatory authorities including the organisation of agency meetings and associated briefing materials
Ensure compliance with EU regulatory requirements including contribution to client and/or companies quality systems
Manage employees and vendors who are engaged in regulatory service activities on behalf of clients or the company
WHAT THE IDEAL CANDIDATE WILL HAVE:
Degree and/or industry Experience
At least 2 yrs experience EAP/PTA or RWD Regs Function
Ability to work independently, or as part of a Project Team
Clinical Trial Regulatory experience is a must
CRO experience preferable
If this role interests you, then please apply now. Upon successful selection for an interview, the process will occur in the following three stages:
First stage: This will be an initial screening call with a Life Science People representative
Second stage: An initial phone call with the hiring manager - Director to go through background and experience in relation to the role.
Final Stage: This will be a final interview, panel style.
This position role is a full-time permanent position, paying up a competitive salary & benefits package.
Full details will be provided on application. If interested, please email with your CV or for further questions.<img src="https://counter.adcourier.com/bGF1cmEuNDk4NzcuMTMwNDJAbGlmZXNjaWVuY2UuYXBsaXRyYWsuY29t.gif">
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