Role: Sr. Regulatory Affairs Manager (CMC) (NO H1B)
Location: Remote
Pharmaceutical Experience Must
Essential Functions:
Manage submissions and projects as assigned by Regulatory leadership assuring compliance, planning, and execution
Represent regulatory on cross-functional teams
Process, interpret and provide recommendations for complex strategies
Provide regulatory and technical expertise to cross-functional teams
Critically review documentation for regulatory submissions and provide input for necessary revisions
Develop and implement regulatory strategies for CMC aspects of drug development and registration
Lead the preparation and submission of CMC sections of regulatory documents (e.g., INDs, NDAs, BLAs, MAAs) in compliance with global regulations and guidelines
Contribute to defining Target Product Profile and build compliant drug “approvable” dossiers and registration
Serve as Liaison for third party service providers
Maintain associated database for tracking individual and department project deliverables for regulatory submissions and milestones
Develop and implement policies, procedures, practices, and strategies for Regulatory Affairs, based on current Health Authority guidelines and regulations
Manage multiple, sometimes conflicting priorities, define issues and obstacles, define risk analysis and execute solutions
Execute objectives in alignment with Regulatory leadership, Marketing, and Global Business Units
Communicate regulatory governmental policy changes to management in a timely manner and provide plans for meeting and complying with new requirements. Understand and recommend strategies based on current local registration requirements and applicable industry standards
Supports the professional development of regulatory staff through mentorship and guidance
Present to upper management at required intervals and effectively communicate successes and challenges
Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)
Requirements
Bachelor of Science in Chemistry, pharmacy, biology or other life science, plus direct experience managing regulatory activities.
Twelve or more years of relevant Regulatory Affairs pharmaceutical industry experience.
Two years of supervisory experience of direct reports required, matrix management experience preferred.
In-depth knowledge of global CMC regulatory requirements, guidelines, and industry practices.
Experience in leading new project submission efforts including strategy, compilation, submission, and approval by a health authority.