Senior Director, Regulatory Affairs
Our client is a biotechnology company. They have asked us to assist them in a search for a Senior Director, Regulatory Affairs.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Provides regulatory expertise and support for pre-clinical, clinical, and commercial areas for investigational and marketed products.
- Designs programs for complete and accurate US and EX US IND/CTA submissions and ensures that clinical trials are designed to meet regulatory requirements.
- Ensures developments of drugs are in accordance with global regulations in order to approve drugs quickly and smoothly within typical approval timeframes.
- Establishes well-defined regulatory pathways and creates accurate and timely documents for IND and NDA submission and final approval.
- Works closely with Program Management, CMC, Clinical Operations and Research teams to develop timelines and clear instructions on what is needed for regulatory submissions.
- Defines regulatory expectations for teams, identifies elements of INDs and FDA required preparation (and other Health Authorities in collaboration with regional regulatory affairs).
- Positions response to regulatory agencies, defines strategy for negotiations and formal document submission, and provides strategic input in the development of the plan.
- Interacts with regulatory agencies and ensures conversations and communications are focused, amicable and documented.
- Oversees the submission of product registration of new drugs, progress reports, supplements, amendments and periodic adverse experience reports.
- Develops strategies, drafts responses and reviews responses and documents intended for submission to FDA to assure compliance with regulatory standards.
- Oversees the review of documents/reports generated by RA support staff, contractors, or other project team members to assess the likelihood that the content will meet pre-specified objectives and provides input towards this end.
- Hold responsibility for management, monitoring, oversight, strategic development and global labeling approvals.
- Recruits, trains and coaches staff as well as evaluates employee performance on an ongoing basis and completes annual performance reviews as appropriate.
- A Master’s Degree in a scientific discipline is required. A PhD is preferred.
- Must have 10+ years of biotech experience in regulatory affairs in multiple phases of development.
- Comprehensive knowledge of the drug development process, drug laws, global
regulations and guidelines is required.
- Requires a comprehensive understanding of global regulatory agencies.
- Must have proven success of submitted sNDA, IND and NDA.
- Full functional knowledge of regulatory requirements pertaining to the development and registration of drug products in multiple ICH regions is required.
- Must have the proven ability to manage multiple projects, as well as identify and resolve regulatory issues.
- Must be able to solicit information, persuade others and shape outcomes.
- Knowledge of clinical, nonclinical and CMC regulatory issues is required.
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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