Associate Director, Regulatory Affairs, CMC - Remote (US)

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 ...

+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- ...

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 ...

+Job summary · The Senior Manager Regulatory CMC will be responsible for the planning preparation and execution of Chemistry Manufacturing and Controls CMC regulatory activities for investigational and commercial products including small molecule and antisense oligonucleotide ASO ...

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. · ...

· We pioneer a moneyball for biotech approach pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. We build bridges to groundbreaking advancements in rare disease develop life-changing medi ...

We are seeking an Associate Director to join our team as a member of the Revolution Medicines team. This position is responsible for developing and implementing global CMC regulatory strategies. The role involves coordinating and preparing CMC sections of regulatory submissions t ...

This position reports to the Functional Area Head, Global Regulatory Affairs. The incumbent is responsible for supporting the development and implementation of regulatory strategies. · Actively contribute to the development of regulatory strategies. · Participate as Global Produc ...

The Senior Quality Operations Manager, CMC is responsible for various operational activities to ensure product quality and compliance. They serve as the quality expert for Praxis pipeline of neurological disease product programs. · Oversee contract service providers (CSPs) for cl ...

The Quality Operations Manager is responsible for a variety of operational activities pertaining to assuring product quality and compliance. · They serve as the quality expert for the Praxis pipeline of neurological disease product programs and is responsible for making strategic ...

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 ...

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 stewardship and global implementation. Thi ...

We are seeking a strategic VP, Product Team Leader (PTL) to lead one or more cross-functional clinical-stage development program from Phase 1 through commercialization. · Lead strategy creation and alignment of internal and external experts with overall product vision for one or ...

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

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 ...

The Senior Director, Medical Writing will join the growing Clinical Operations organization and serve as the strategic and operational leader for all medical writing activities across clinical development programs. · This high-impact position will partner cross-functionally with ...

This leadership role is responsible for developing and implementing global regulatory strategies for clinical investigational studies and commercialization of vaccines for both adult and pediatric populations. · Bachelor’s degree in a relevant scientific or technical discipline. ...

The QMS Business Process Owner is responsible for managing assigned escalated GxP and Quality incidents in an end-to-end process on global level. · ...

+ Job summary + · + BenefitsComprehensive benefits package · ...