Senior Director Regulatory Affairs, CMC - Remote (US)

We are seeking an Associate Director of Regulatory Affairs CMC to develop and implement global regulatory strategies for assigned product(s) in line with business objectives. · ...

The Senior Director, Regulatory CMC will provide strategic and operational leadership for CMC regulatory activities across both investigational and commercial products at Praxis Precision Medicines, · Advanced degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or ...

· Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed. · The Opportunity · The Senior Director, Regulatory CMC will provide strategic and operational leadership for CMC regulatory activities across both investigati ...

+Job summary · Senior Director, CMC Regulatory Affairs is responsible for leading the development, execution, and maintenance of global CMC regulatory strategy to support clinical development,+QualificationsAdvanced degree (MS, PhD, PharmD) in Chemistry...++Strategic Leadership- ...

· Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed. · The Opportunity · The Senior Manager, Regulatory CMC will be responsible for the planning, preparation, and execution of Chemistry, Manufacturing, and Contro ...

This position may be performed remotely, but requires the flexibility and willingness to travel as needed. · Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline (advanced degree preferred). · 5+ years of Re ...

BridgeBio is looking for an Executive Director to lead global CMC regulatory activities across development and commercial products. The successful candidate will provide strategic and operational leadership for CMC regulatory strategy and ensure high-quality submissions. · ...

· Mavericks Wanted · When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks on · In 2015, we pioneered a "moneyball for biotech" approach, pooling projects and promising early-stage research from ac ...

· Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers.  The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of R ...

· Summary · This position reports to the Functional Area Head, Global Regulatory Affairs.  The incumbent responsible for supporting the development and implementation of regulatory strategies, work closely with the cross functional asset teams to prepare, review and submit regul ...

The Associate Director, Quality Operations – Commercial & Stability will lead the development and execution of quality oversight strategies across commercial and clinical supply chains, · Provide strategic leadership for commercial and clinical stability programs, · Oversee quali ...

Pulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for patients suffering from pulmonary diseases. · Able and willing to do hands on document formatting and regulatory publishing. · Responsible for all documents and submissions to b ...

Job Description Summary · The Global Head, Regulatory Affairs – Labeling sets the enterprise labeling vision and delivers the strategic labeling agenda across PDx: from target product profile (TPP) and target product labeling (TPL) through Company Core Data Sheet (CCDS) stewardsh ...

We are looking for an experienced professional to lead and manage the Clinical Supply activities within the planning organization. · Lead Clinical Supply teams as part of an overall global supply chain management role. · Provide managerial support to several employees with overal ...

· Mavericks Wanted · When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks on · In 2015, we pioneered a "moneyball for biotech" approach, pooling projects and promising early-stage research from ac ...

· Mavericks Wanted · When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks on · In 2015, we pioneered a "moneyball for biotech" approach, pooling projects and promising early-stage research from ac ...

· Why Join Us? · Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines that unlock high-impact protein targets long-considered undruggable. The company has developed a new class of stabilized, cell-penetrant alpha-helical ...