Senior Director, Regulatory Affairs
Our Client is a biotech company focusing on drug discovery and drug development. They have asked us to assist them in their search for a Senior Director, Regulatory Affairs
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Establishes strategic direction and leads the development of regulatory submissions and related documents.
- Guides teams around the development and employment of regulatory strategy through the clinical and nonclinical development processes.
- Conducts risks and gaps assessment and identifies potential areas of regulatory concern. Responds to new government/regulatory developments.
- Monitors regulatory developments with focus on vaccine development and guides teams through the clinical development processes.
- Establishes and maintains positive relationships and negotiates with global health agencies concerning company’s filings.
- Responds to requests for additional data, and organizes and manages participation in meetings.
- Assesses and approves technical data and confirms accuracy of clinical data and execution of clinical projects to regulatory authorities.
- Assures current policies and practices are in compliance with federal and international regulatory agencies.
- Serves as regulatory affairs executive to provide input on trials and filing activities, and to ensure that report systems are maintained and compliant.
- Monitors regulatory publications to keep apprised of new or changing regulatory developments and potential strategic impact.
- Develops and maintains the Target Label Profile and the Company Core Data Sheet.
- Reviews all external materials for regulatory compliance.
- Collaborates with company teams and external partners to achieve project goals, including content development and management submissions.
- Serves as overall global regulatory lead accountable for all regulatory aspects of his or her assigned project(s), including development and implementation of the global regulatory development plan for the project.
- Ensures the global regulatory strategy for assigned project(s) is coherent with the business goals and have been negotiated with health authorities as appropriate.
- Identifies areas in need of improvement and leads the development and implementation of process improvements.
- Manages resources for assigned project(s), including ensuring adequate regulatory resources, skills, and budgets are available to deliver the project deliverables.
- BA/BS degree in a scientific/engineering discipline is required. Advanced degree preferred.
- Requires 12+ years of experience in the pharmaceutical industry.
- Requires experience in regulatory strategy, specifically in vaccine development.
- Must have expert knowledge of relevant FDA, EU, and ICH guidelines and regulations related to infectious disease vaccine programs.
- Strong experience with CTD format and content regulatory filings is required.
- Experience with developing and implementing competitive regulatory strategies is required.
- Requires track record in securing product approvals and maintaining a complex portfolio.
- Must have comprehensive experience with regulatory procedures and legislation for drug development, product registration, line extension, and license maintenance, preferably from both US and EU.
- Direct experience of leading regulatory authority meetings in different phases of drug development is required.
- Regulatory knowledge across infectious diseases and vaccine development are preferred.
- Delivery of at least one major application is preferred.
- Requires ability to work independently to manage multiple projects in a fast-paced environment.
- Must have the ability to collaborate effectively in a dynamic, cross-functional matrix environment, to drive meeting each program’s critical regulatory milestones.
- Partnering with internal teams and company partners to develop content and manage submissions to regulatory bodies is required.
- Must effectively communicate the regulatory strategy, risks, mitigations, and overall plans to Regulatory Affairs the Project Team and senior management, as relevant.
- May be responsible for line management and development of direct reports.
- Requires identifying areas in need of improvement and leading the development and implementation of process improvements.
- Must have outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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