Senior Manager / Associate Director, Regulatory CMC

Edgewise Therapeutics, Inc.; United States; Teletrabalho; USD 150 000 - 210 000; Tempo integral

Resumo da oferta

Edgewise Therapeutics, Inc. is seeking a Regulatory CMC professional to contribute to cardiovascular therapeutic development teams.

The role encompasses regulatory CMC input for product development and submissions for US and global programs, with collaboration across Regulatory Affairs, CMC, and Quality to ensure compliance and successful milestones. Requirements include 5+ years in CMC Regulatory Affairs, experience with submissions (INDs, NDAs), and familiarity with Veeva RIM; remote work

Qualificações

• 5+ years of experience in CMC Regulatory Affairs.
• Experience preparing submissions and regulatory documents.
• Knowledge of US and global regulatory submissions (IND/NDAs) and lifecycle management.
• Experience with regulatory document management systems is preferred.

Responsabilidades

• Contributes regulatory CMC input to product development and registration for small molecule products.
• Writes, edits, and compiles CMC documents for US and global submissions (INDs, NDAs, MAAs, etc.).
• Reviews CMC documentation and ensures data QA and traceability.
• Collaborates with Regulatory Affairs, CMC, and Quality to ensure compliance and change controls.
• Prepares regulatory submissions using document management systems and archives.
• Supports development of overall regulatory strategies and milestones.

Conhecimentos

CMC Regulatory Affairs

Regulatory Strategy

Cross-functional Collaboration

Regulatory Submissions

Veeva RIM experience

Ferramentas

Veeva RIM

Descrição da oferta de emprego

This position will contribute regulatory CMC experience to Edgewise cardiovascular therapeutic development teams.

Essential Job Duties and Functions:

• Responsible for regulatory CMC contribution to product development and registration for small molecule investigational products. Conduct risk assessments and recommend development options.
• Contributes to the writing, editing, reviewing and compiling of CMC documents needed for regulatory submission activities for US and global assigned products. The submissions include IMPD, INDs, CTAs, NDAs, MAAs, meeting requests, briefing documents, and annual reports, as well as contribution from a CMC perspective on other submissions and clinical documents.
• Provides critical review of CMC documentation supporting regulatory submissions and communications and oversees data verification/QC.
• Collaborate cross-functionally with Regulatory Affairs, CMC, and Quality to ensure compliance such as manufacturing records review, release and change controls.
• Prepares regulatory submissions using regulatory document management systems and archival of regulatory documentation.
• Ensures CMC regulatory milestones are met to support regulatory submission and overall business goals of the Company.
• Contribute to the development of the overall regulatory strategies.
• May oversee external vendors and contractors with responsibility for providing regulatory support to ensure project deliverables are achieved.
• Builds professional and effective internal and external relationships crucial to the success of the programs.
• Works across internal departments to maintain credibility, trust, and support of employees and other stakeholders.
• Other duties as assigned.

Required Education, Experience and Skills:

• 5+ years of experience in CMC Regulatory Affairs.
• Experience with Veeva RIM or similar document management system is ideal.
• Experience in the preparation of submissions, regulatory documents, annual reports, amendments and supplements.
• Proven ability to strategize with team members in the optimal way of documenting various submissions.
• Experience with creating and managing timelines for CMC submissions; use of project management tools is a plus.
• Demonstrated knowledge of regulations and guidance affecting clinical development, registration, and lifecycle management, and staying current with Regulatory CMC trends.
• In-depth knowledge of overall global drug development.
• Excellent written, interpersonal and communication skills.
• Self-starter with experience working in a remote environment.
• Able to adapt to rapidly changing timelines and priorities.
• Easily gains trust and support of peers, is a team player, and encourages collaboration.

Salary range: $150,000-$210,000, title and salary commensurate with experience