Summary

The Regulatory Affairs Specialist position provides specialized regulatory support to the Director of Quality Assurance and Regulatory Affairs in support of the Section of Pediatric Tropical Medicine at Baylor College of Medicine vaccine initiatives. Under the guidance and direction of the Director, the Regulatory Affairs Specialist supports administrative and project related duties of the department as assigned, including coordinating, operations, and completing regulatory submissions, and support during external assessments, audits, and/or inspections, as requested. The Regulatory Affairs Specialist also assists in developing and implementing regulatory strategies and processes to ensure timely development, manufacturing, and distribution of products in compliance with applicable regulations and standards. This position works closely with cross-functional teams within the Texas Children's Hospital Center for Vaccine Development (TCH-CVD) and its partners to prepare regulatory submissions. 

Job Duties

• Provide operational, administrative and logistical support for the Quality Assurance and Regulatory Affairs units 
• Coordinate regulatory correspondence across internal stakeholders and external institutions 
• Assure distribution of appropriate information between investigators, regulatory agencies and personnel involved in implementation of research projects
• Act as a liaison between regulatory agencies, the sponsor and the investigators to ensure that protocols and protocol amendments are submitted appropriately and that annual reviews are submitted in a timely manner
• Coordinate and participate in planning and developing regulatory strategies for project implementation and operational activities
• Maintain and expand understanding of federal regulations, ICH guidelines and internal SOPs by producing work in compliance with those regulations, guidelines and SOPs
• Work closely with cross functional teams to ensure that all regulatory documents for research studies are up-to-date so as to streamline work and achieve mutual goals
• Attend all required meetings to develop an understanding of the vaccine development landscape in order to more accurately assist in the preparation of submissions 
• Prepare protocol documents and required regulatory forms in order to obtain institutional and regulatory agency approval 
• Plan and pursue activities to promote self-development related to vaccine development and regulatory issues
• Participate in project team meetings and interact to advance regulatory projects
• Responsible for regulatory approvals from FDA and foreign regulatory agencies
• Ensure quality, reliability and safety of products through development and manufacturing phases
• Assure compliance with local, county, state and federal agency regulatory requirements, including cGMP
• Assure compliance with the quality system
• Provide a critical review of data or reports that will be incorporated into regulatory submissions to ensure scientific rigor, accuracy, adequacy, consistency and conformance to regulatory requirements
• Compile and maintain regulatory documentation databases or systems
• Coordinate efforts associated with the preparation of regulatory documents or submissions
• Coordinate, prepare, and review regulatory submissions for domestic or international projects 
• Familiar with eCTD preparation and submission
• Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
• Maintain in-depth knowledge of current regulatory requirements and emerging regulations, standards, or guidance documents
• Stays abreast of regulations pertinent to biologics and drugs, as needed
• Maintain regulatory files in a compliant fashion, assuring they are audit-ready
• Coordinate and submit timely responses to regulatory agency inquiries

Minimum Qualifications

• High School diploma or GED.
• Four years of relevant experience.

Preferred Qualifications

• Bachelor’s degree in a health-science discipline
• 1-3 years professional experience within an FDA regulated industry, preferably  pharmaceuticals and/or within an academic medical center setting that routinely requires regulatory submissions to FDA and other regulatory institutions OR 3-5 years of directly related experience without a Bachelor’s degree.  
• Proficiency with MS Word, Excel and Adobe
• Proficiency with document control and reference management software
• Basic understanding and application of principles, concepts, practices and standards, and knowledge of industry practices
• Basic understanding of GxPs (GCPs, GLPs, GMPs) and regulatory guidelines such as FDA and ICH guidelines
• Requires excellent written and oral communication skills
• Requires the exercise of tact and diplomacy in dealing with faculty, staff and students.
• Proficient in the use of a personal computer and Adobe Acrobat, MS Word and Excel Microsoft software programs
• Prior experience with data management of research and regulated protocols may be required
• Must be extremely resourceful and able to work independently, with limited supervision
• Ability to multitask, problem solve, set and meet deadlines
• Ability to work collaboratively with all levels of staff and range of personalities, culture and working styles
• Excellent project management and organizational skills 
• Ability to perform detail‐oriented work with a high level