Director of Regulatory Affairs
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Accentuate Staffing is assisting a biotech client in Research Triangle Park, NC who is looking to double their headcount within the next 6 months. We have multiple positions in Regulatory Affairs available for those that want to be part of an exciting company and be part of helping to set the direction. These are direct hire opportunities!
Responsibilities:
- Will develop global regulatory strategies, provide regulatory guidance, create, manage and critically review documents for submission to regulatory authorities, and oversee the execution of the regulatory strategy
- Responsible for leading all regulatory activities for assigned projects in line with ICH requirements, regional requirements and scientific and company policies and procedures
- Contributes to the development of global clinical and regulatory plans and strategies, identifies and proposes risk mitigation strategies, and influences project teams and subteams
- Prepares and manages submissions (CMC, Clinical, nonclinical; amendments, supplements and briefing materials) that are technically complex and require extensive interaction with departments outside of regulatory affairs.
- Participates as needed in acquisition due diligence
- Maintains knowledge of highly complex regulatory requirements up to current date, contributes to the preparation of new regulatory guidance wherever possible, comments on draft regulatory guidance and communicates changes in regulatory information to project teams and senior management.
- Responsible for development of annual budgets and forecasting for their assigned programs. Ensures all expenditures are managed in accordance with agreed budgets and forecasts.
- Recruit, hire and develop Regulatory Affairs staff as needed.
- Must have knowledge of regulatory requirements, including ICH requirements and regional requirements and have an understanding of current global and regional trends in regulatory affairs and ability to assess the impact of these requirements to the business.
- Must be capable of developing and implementing regulatory strategies, handling the process and managing complex interactions and negotiations with global regulatory authorities.
Requirements:
- BS/BA degree, PhD preferred (life sciences preferred).
- Minimum of 15 years of applicable experience (biotech/pharma/research firm) with at least 10 years in a regulated role.
- Experience as a global regulatory lead managing investigational products is required.
- CMC, Gene therapy and rare disease experience desired.
- Ability to multitask among multiple projects and teams and work independently in a fast-paced, highly interactive environment.
