Senior Manager of Regulatory Affairs (CMC) required…

RBW Consulting
40,000 - 60,000
01 Oct 2017
03 Nov 2017
Contract Type
Full Time
A fantastic pharmaceutical household name has recently set out to expand it’s regulatory department and they are now seeking a Senior Manager (CMC) for a full time permanent vacancy. This exciting opportunity would see you: · Organising, creating and overseeing Module 2 and 3 CTD regulatory submissions (CTAs, MAAs, BLAs, NDAs, INDs, IMPDs, Briefing documents and meeting requests) · Managing the internal review and submission of these items · Giving support to EU and US (and global) clinical trials as well as commercial licence maintenance · Providing reports of protocols, reviews, presentations and documents · Managing response to regulatory agencies · Manage timelines to ensure approvals are timely and development objectives are met · Representing CMC regulatory throughout internal meetings as well as providing support at meetings alongside business partners and regulatory agencies on CMC issues · Keeping an eye on global CMC regulations and make sure any changes are controlled so all development activities comply with current regulations and guidelines · Managing change control process · Actively participating in electronic publishing and quality verification of regulatory submissions · Managing risk assessments and providing these with recommendations for various regulatory scenarios. You will need experience working with eCTD submissions, CMC regulatory environments, CMC regulatory documents (MAA, BLA, NDA, Variations, Responses, CTAs and INDs etc.), Knowledge of FDA, EMA and ICH guidelines, 5 years minimum CMC regulatory experience. All of this will see you inside one of the leading global pharmaceutical companies with a fantastic work environment. Pay is competitive and exact package can be discussed over the phone. If you are thinking this could be the right role for you then apply now! – I look forward to hearing from you.