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DIRECTOR OF REGULATORY AFFAIRS Endocyte
THIS JOB HAS EXPIRED
As a Director of Regulatory, you will be responsible for establishing and maintaining good working relationship between Endocyte and regulatory agencies through effective, efficient communication and adherence to regulatory procedures. The Director will also prepare and review regulatory documents to ensure that documents meet regulatory specifications and submit documents to regulatory agencies as required. You will function as a contact for negotiations and interactions with domestic and foreign regulatory agencies, including preparation and attendance at FDA meetings, regular FDA communication, and responding to FDA comments and questions in a timely professional manner. You will also determine FDA interaction objectives, oversee preparation and follow-up for meetings, and insure appropriate involvement of Endocyte management. As well as define timelines and work plan for preparing and submitting regulatory documents including IND, NDA and annual reports.Additional responsibilities for this position include:
Contribute to the selection process of new hires, including reviewing candidate?s credentials, interviewing candidates, and making hiring recommendations
Directs and controls the activities of one or more functional area with overall responsibility for the direction of those assigned
Implement and follow company/departmental policies, procedures and SOPs
Special projects as requested
Job Requirements
As a Director of Regulatory you will be required to be on-site during the core hours of the day, 8:00 am ? 5:00 pm. Hours and location may vary depending on work load. Some travel is required to support interactions with domestic and foreign regulatory agencies across the country and outside the US, if needed. Frequency is variable, from as few as 1 trip per quarter during non-peak workloads to 1-2 trips per month during peak workloads. Trip length is typically 1-2 days.
Skills:
Extensive experience preparing INDs and other regulatory documents
Knowledge of regulatory compliance issues and requirements
Detailed knowledge of cGXPs
Demonstrated ability to develop effective working relationship with regulatory reviewers and personnel
Excellent written and communication skills and ability to work within a team as well as independently
Well organized and capable of managing multiple projects simultaneously
Education/Experience:
Bachelor degree in life science field
Minimum of 5-8 years of
| Location: | 3000 Kent Avenue Suite A1-100 West Lafayette, IN 47906 United States |
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THIS JOB HAS EXPIRED
Endocyte
Investors: Blue Chip Venture Company, Burrill & Company, Clarian Health Ventures, Sanderling Ventures, Triathlon Medical Venture PartnersAll Jobs: at Endocyte
| Web Site: | www.endocyte.com |
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| Headquarters: | 3000 Kent Avenue Suite A1-100 West Lafayette, IN 47906 United States |
| Industry: | Biotechnology |
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