2 ASSOCIATE DIRECTOR, REGULATORY AFFAIRS Jobs in Bethesda, MD
Technical Resources International, Inc. is Hiring an ASSOCIATE DIRECTOR, REGULATORY AFFAIRS Near Bethesda, MD
- Assists in managing the overall process of regulatory submission preparation and review, including Investigational New Drug applications (INDs), Biologics License Application (BLAs), New Drug Application (NDAs), investigational device exemption (IDEs), Annual Reports, and other regulatory documents
- Manages and/or supervises a Team of Regulatory Managers, Regulatory Specialists, Regulatory and Operations Associates
- Supports the Department Director in ensuring compliance with the applicable domestic and international regulations and guidelines including Good Manufacturing Practice (cGMP), current Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and providing support for TRI’s internal Quality Assurance Program/Quality Systems
- Supports the development of the Standard Operating Procedures (SOPs) that support the Regulatory Affairs operations
- Collaborate with external consultants, clinicians, CROs to provide regulatory guidance.
- Maintain detailed knowledge of global regulatory environment.
- Escalate issues to Management that affect regulatory compliance.
- Ensures high quality work products are consistently delivered on time to the client, the FDA, and other Regulatory Health Authorities.
- Interacts with study sponsors, project managers, clinical research staff and Food and Drug Administration (FDA)/other Regulatory Health Authorities to ensure timely receipt and submission of information required for regulatory submissions
- Maintain Regulatory Intelligence program to keep Regulatory Managers and TRI senior management abreast of changes in U.S. and international regulations and guidances that may impact the TRI projects.
- Coordinates professional development as needed to support regulatory document preparation, regulatory intelligence, and regulatory strategy, and to stay current with applicable therapeutic areas of clients
- Assists the Department Director with staff recruiting, hiring, training and recruitment strategies, and staff performance evaluations
- Develops and implements project plans, procedures, and work instructions for new statements of work for existing and new clients
- Supports the preparation and review of technical proposals
- 5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
- Strong scientific, regulatory affairs, clinical research, and/or project management background.
- Solid working knowledge of drug development process and FDA regulatory requirements
- Solid working knowledge of ex US regulatory requirements preferred
- Strong management and leadership skills; experience in leading regulatory operations/submissions teams a plus
- Direct experience interacting with government regulatory authorities a plus
- Excellent oral and written communication skills; detail-oriented and able to multi-task/prioritize well.
- Proficient in Microsoft office; experience with SharePoint a plus.
- Superior organizational skills and customer service abilities.
- Ability to analyze medical research data and review experimental protocols.
- Experience in preparing regulatory plans and providing regulatory guidance
- Experience with managing preparation of regulatory documents, publishing regulatory submissions using electronic publishing software and proficiency in preparing documents that are compliant with electronic submission standards.
- Must be able to exercise initiative and sound judgment, and to prioritize ongoing projects.
Job Summary
Full Time
Business Services
$180k-238k (estimate)
05/29/2023
05/13/2024
tech-res.com
STEWKLEY, ENGLAND
200 - 500
1979
<$5M
Business Services
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The job skills required for ASSOCIATE DIRECTOR, REGULATORY AFFAIRS include Regulatory Affairs, Leadership, Initiative, Project Management, Written Communication, Drug Development, etc. Having related job skills and expertise will give you an advantage when applying to be an ASSOCIATE DIRECTOR, REGULATORY AFFAIRS. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by ASSOCIATE DIRECTOR, REGULATORY AFFAIRS. Select any job title you are interested in and start to search job requirements.
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