Expiry Date: 20-04-2022
Categories Biotech, Regulatory Affairs
Job Type: Full Time
Senior Manager Regulatory CMC Process Improvement & Training, Boston, MA
About My Client
This is a well-known successful and well-run biotech company, with a stable of high value marketed products, all with new modalities or first-in-class drugs - it really is both pioneering and ground-breaking in its science and therapies. You will be joining a small team of several individuals, who support the ‘engine’ regulatory CMC uses for all their investigational and marketed products and submissions, in the USA and worldwide, to be able to generate high quality Modules and documentation for the regulatory submissions in all the major (US, EU, China, Japan) and international markets.
About the Role
The overall size of the team is around 50 FTEs working in regulatory CMC worldwide, and this team is part of Tech Ops and Manufacturing (IMPs and Marketed). The teams are working across the full project lifecycle, so the systems and processes, tracking and intelligence systems, as well as the training manuals, reflect their remit.
In this role you will be part of a Business Excellence team, supporting the ‘engine’ and working in collaboration with other functions, vendors and partners, to enhance how regulatory CMC works, through process mapping, process improvement, change management (new or enhance systems, new ways of working, new technologies). You will have two main accountabilities, process mapping and improvement, as well as the quality manual, so this means you will also need to steer the training manual to be able to bring change in, in a supportive and methodical manner. You will support KPIs development and tracking as well.
Your Experience & Interest
It is likely you will have around 7 years or more in industry with around 3-4 years in either regulatory sciences for CMC or in an accompanying career pathway (MSAT, Quality Assurance Management, Regulatory Training) and be technically literate in CMC regulatory and regulatory affairs. You will have led or support process improvement activities, either as a full time job or as part of a wider role, and now want to specialize in this area. Your ideas, effort and diligence will be rewarded in this company, and the leadership team has many examples of people developing up.
Package & Covid
My client offers a quicker vesting stock plan, normal health and insurance benefits, as well as a high performing bonus plan. The company will buyout stock and bonus within reason. The role will require office working, but a hybrid model is available for individuals based on their needs and location. My client offers relocation into the Boston, MA and North Carolina locations.
To apply for this role, please press the red “Apply for position” button, or contact me, Theo Moore on 855-505-1382, or my colleague Matt Greig on 908-332-9157. We will support you throughout the interview and on-boarding experience.
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