Renee Yancey
Sr. Director Regulatory Affairs CMC Strategy
- Role
- Sr Director Regulatory Affairs Cmc Strategy at X4 Pharmaceuticals
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Renee Yancey
I am distinguished as an accomplished strategic people leader within the pharmaceutical industry, showcasing an extensive track record in Regulatory Affairs Chemistry, Manufacturing, and Controls on a global scale. Adept in the execution of innovative RA CMC strategies for drug registrations for small molecule drugs, facilitating multinational regulatory drug approvals, and overseeing comprehensive life-cycle global CMC dossiers. I am recognized for consistently delivering strategic guidance, leveraging stakeholder relationships and providing leadership across RA CMC initiatives. Renowned for navigating multifaceted projects, crafting astute business strategies, orchestrating and leading cross functional, high-caliber teams, engaging effectively with FDA and international regulatory agencies, and spearheading technical excellence in pharmaceutical advancement. Interact and Negotiate with FDA | Identification of Key Issues | Anticipate Future Business Concerns | Influence through Effective Communication | Lead and Encourage Collective Responsibility of Multi-functional Teams | Execute Innovative Regulatory Strategy | Focus on Results and Milestone Progression | Risk- Based Resolutions| Pre and Post-Approval Submissions | Global Marketing Applications | INDs| IMPDs | Manufacturing Site Transfers | Regulatory Compliance | Regulatory CMC Strategy | GMP Change Control Assessment | eCTD Submission Coordination| ICH | Project Management | Mentor and Train| Strategic Leadership | Due Diligence and Business Development | Risk Resolution| Problem Solving | Small Molecule
Experience
Sr Director Regulatory Affairs Cmc Strategy
Jul 2024 — Present · Boston, MA, US
Education
University of Massachusetts Amherst
BS, Microbiology, Biochemistry
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.