RA CMC Director ** Smaller, well-funded Biotech ** More Autonomy, More Strategy ** Pure development role for SM and/or Bio ** Fully Remote
ADV Talent Partners
Middlesex County, MA
Permanent
Full-time
1 month ago
Apply easily
Location: Fully Remote (HQ on the East Coast) from most East Coast or Central Time Zone Locations including New Jersey, Pennsylvania, Massachusetts, New Hampshire, Ohio, Florida, South Carolina, Texas, Illinois + moreWe have an exciting opportunity with a small, friendly and growing dynamic Biopharmaceutical company with a strong and established leadership team who are building a unique portfolio of innovative, first-in-class therapeutic candidates for rare diseases. They are well-funded and have a growing pipeline.This organization is young, but they already have a global footprint with offices in Massachusetts and Central Europe and they are currently initiating several clinical trials with both biologic and small molecule programs. You will find this opportunity interesting if you enjoy leading regulatory-CMC strategies from early- to late-phase development and NDA/MAA preparations.As the Director of Global Regulatory Affairs CMC (Reporting to the Senior Director, Regulatory Affairs-CMC) you will act as the primary regulatory representative on assigned projects, defining the company regulatory strategy for their Small Molecule and/or Biological programs, drawing from your experience in creative and reasoned thinking to maximize opportunities and mitigate risks.This is a full-on development role, where you will lead regulatory-CMC discussions with regulatory authorities and define and lead the execution of the global regulatory-CMC strategy from early- to late-phase development and NDA/MAA preparations. You will review and provide regulatory assessments on change controls and help the company develop more SOP’s. You will also have close collaboration with the development teams and visibility to the executive leadership team with meaningful opportunities for professional development and career growth.The Ideal Candidate:You will have a strong technical background in Regulatory Affairs CMC in Small Molecules and/or Biologicals and will know late-stage development and NDA preparation with experience in Global regulatory strategy, requirements and guidelines (incl. FDA, EMA, PMDA). You will have strong regulatory filing experience including Health Authority briefing packages, IND/IMPDs, and NDA/MAAs and enjoy working for a smaller organization, where there is closer collaboration, greater levels of autonomy and more flexibility. You will enjoy being involved in elements of decision-making at an earlier stage than you would in a larger organization and appreciate a platform and environment where you can continue to grow and be challenged, but still supported.Responsibilities:
Develop and lead the execution of the global regulatory-CMC strategies from early- to late-phase development and NDA/MAA preparations
Represent regulatory CMC on cross-functional project and technical teams
Lead regulatory-CMC discussions with regulatory authorities
Review, interpret and assess the impact of new regulations, identifying potential opportunities/risks
Support the growth of the organization and the global Regulatory CMC department
On offer is a very competitive package at Director grade, including strong basic, bonus and stock. You will also have the opportunity to work remotely or from offices in Cambridge, Massachusetts.If you are interested in applying or hearing more about this role, please contact me, Theo Moore on 587.216.9302 or via today, and we will support you with your application.
