Sr. Regulatory Affairs Manager (CMC) (NO H1B)
Sr. Regulatory Affairs Manager (CMC) (NO H1B)
IT Engagements, Inc.
United States
See who IT Engagements, Inc. has hired for this role
Greetings from IT Engagements
Role: Sr. Regulatory Affairs Manager (CMC) (NO H1B)
Location: Remote
Pharmaceutical Experience Must
Essential Functions:
vinaya@itengagements.com
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.)
- 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.
- Experience writing Target Product Profiles, non-clinical studies, reviewing Clinical protocols and summary reports.
- Preparing for and executing Health Authority meetings.
vinaya@itengagements.com
-
Seniority level
Mid-Senior level -
Employment type
Contract -
Job function
Legal -
Industries
Hospitals and Health Care and Pharmaceutical Manufacturing
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