Expiry Date: 14-01-2022
Categories Biotech, Regulatory Affairs
Job Type: Full Time
Director CMC RA Director ** Lead a lifecycle team on blockbuster recombinants ** RTP, NC, or Remote
About This New Opportunity
You will be someone who knows how to motivate people managing a work stream which is multi-product, global, includes US and EU, with a focus on Drug Product and Combos (there is a device team for the device registrations) for a busy lifecycle strategy covering 90 plus countries. You will be working in a newly established model and be responsible for hiring and on-boarding ADs and Senior Managers from the get go. This is for someone who wants to build something new, from the existing foundations, and storm, norm, perform to achieve a high performing team that is visible, productive and satisfied.
The company is a medium sized bio/pharmaceutical company well-known for their ground breaking therapeutics and with a fairly decent reputation for innovation and successful registrations.
You will be someone who likes working in a busy group, knows how to provide the team with the appropriate amount of support and coaching, and this will include building new headcount, performance and appraisal, as well as stakeholder management and keeping oversight of emerging potential risks and challenges, working closely with supply chain (incl. US based East Coast CMOs), internal manufacturing, therapy regulatory and quality. The Technical Lead is ex regulatory.
The role can be remote or based in the location in the advertisement, a relocation package is available for the right candidate.
About You & Your Expertise
You will be an experienced CMC expert with knowledge of DP, Steriles, and have worked on multi-regional (not necessarily global but global is preferred) lifecycle strategies for bio products, in regulatory CMC team leading position(s) – again if you have managed 4-6 FTEs in matrix but not direct, this is equivalent experience.
You will be someone who naturally leans to collaboration with stakeholders, likes to work in a flat matrix at the management level, and knows how to identify and engage with key teams and ensure smooth delivery and execution. You will relate to this sentiment as something you are good at!
You will enjoy flipping challenges to plans that can be executed by mentoring and coaching your team and keeping an appropriate amount of oversight.
You will have between 10 years plus although this could be augmented by early career experiences or Masters or PhD research.
The package includes a decent quicker vesting stock plan, high end bonus, and the company will equalize for the right candidate your stock or bonus losses.
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