Expiry Date: 15-09-2021
Category Regulatory Affairs
Job Type: Full Time
Associate Regulatory CMC Director ** GRL, Ph 3 to MAA on glowing NCE ** Grow into a Team Manager - Durham, RTP
This is one of the most successful medium-sized biotech’s with a large stable of blockbuster products, few competition in their therapy classes, and the people we work with at this client, are the first to admit, ‘to live the dream’, developing high unmet medical need products with a high degree of success in a company which is action item and progressive, culturally, scientifically and persona wise.
The company is mostly known for neurology products including disease modifying and novel MOAs. This role is to lead for Regulatory CMC one of these late phase development products out of Ph 3 and into first NDA and first MAA.
You will be someone who views input into strategy development and filing planning, with risk identification and knowing the differences in CMC requirements regionally as potentially 3 main pillars for successful registrations, but you also know, the soft skills, influencing, collaborating and advocacy for strategy and risk could be considered as the glue to make it all happen.
You will want to do this role if you have worked before on first MAAs and NDAs and like this type of role, yes you will do lifecycle eventually, for a couple of new dosage forms, but most likely, you will rotate to a new program for a NCE after leading the 1st and 2nd waive NDA/MAA filings.
My client will give leeway to US or EU regulatory experts with 1st filing NDA or MAA experience, who have not yet led a global filing, but have worked with their counterparts and have more than a glancing view at the other regions pathways and requirements, what she realty wants is, and the emphasis is here, that you have first M3 QoS MAA or NDA filing experience, not just purely line extensions.
You will be onboarded and developed into a full GRL role for CMC regulatory, and if you want, and have built the motivational and people development cornerstones in leading your sub-team pre submission, you will go on to have direct reports. This is down to you as an individual and what you want, the role as GRL for CMC RA is the first ticket we are offering.
The roles can be based in a number of locations, all benefit from relocation if needed, and include in the USA North Carolina, Massachusetts, or Heathrow / West of London area, in the UK.
The package includes a stock plan, bonus, high end salary, and various additional incentives, the UK package includes a car allowance.
During Covid: You will be interviewed by MS Teams and will initially during 2021 work remotely from home; if you require relocation then this can happen Summer 2021, even if you do not attend site until it is safe to do so. Relocation is funded!
To apply for this role, please contact me, Theo Moore on US toll free 855.505.1382 or send a full CV to Theo@AdvTalent.com and I will reply by return. Alternatively, press the red “Apply for position” button and follow the registration process.
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