Opus Regulatory Inc. · 11 hours ago
Principal Consultant, Regulatory CMC Strategy
United States
Full-time
Remote
Senior Level, Lead/Staff
10+ years exp
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Hiring Manager
Austin Hanson
Insider Connection @Opus Regulatory Inc.
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Responsibilities
Responsible for managing activities of assigned Regulatory Affairs CMC team with emphasis on global regulatory strategy and the preparation, review and submission of documents for FDA and other regulatory authorities.
Supports the regulatory function on assigned development/commercial programs providing CMC regulatory guidance and strategy including identifying and assessing regulatory risks
Critically review and provide strategy input on regulatory filling documents (e.g. pre-INDs, INDs, IMPDs, BLAs, MAAs, annual reports, DSUR, amendments, supplements).
Lead and facilities activities, including team preparation, for meetings with FDA and other regulatory authorities for CMC development activities
Experience in authoring complex technical documents, CMC regulatory CTD (M2 and M3) sections, and life cycle management.
Proactively identify program issues and develop appropriate regulatory strategies to mitigate risks
Perform RA-CMC compliance activities to support IOPS organization.
Coordinate and lead regulatory inspections, as needed, at the Rensselaer site or at other sites if the inspection relates to regulatory CMC issues.
Monitor emerging legislation and guidance in the CMC field and contribute to ensuring company-level awareness and compliance (where appropriate).
Qualification
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Required
A minimum of 10 years pharmaceutical/biotech experience including a minimum of 5 years relevant CMC experience
Background in scientific discipline and expertise in at least one area in pharmaceutical development (e.g., chemical process, formulation, manufacturing, QC, QA, etc.)
Bachelor’s degree
Extensive regulatory affairs knowledge and familiarity with RA concepts, procedures, practices, methods, and industry standards
Substantial project management skill, with a demonstrated ability in planning, implementing, and executing tasks to meet RA goals
Regulatory submission knowledge, including eCTD and NDA/IND requirements
Steadfast attention to detail; ability to identify and communicate methods for improving existing processes
Ability to work in an ever-changing pharmaceutical environment
Knowledge of regulatory affairs teams and ability to recognize when leadership is needed
Ability to work collaboratively and direct the work of others toward common goals
Preferred
Advanced degree in a science discipline
Company
Opus Regulatory Inc.
At Opus, we measure success with mutual client and consultant satisfaction. We achieve this by leveraging the right person for each project.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Dave Sawyer
CEO and Founder
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