SENIOR MANAGER, REGULATORY AFFAIRS

This individual will work closely with senior Regulatory Affairs staff and/or cross-functional team members to develop submission timelines, outlines, and/or strategies. This position will also include preparation of regulatory documents, reviewing for regulatory compliance and monitoring of new guidances from various regulatory agencies.

RESPONSIBILITIES AND JOB DUTIES:

• Working with the Director, Regulatory Affairs to design and implement global regulatory development strategies
• Interacting with Clinical, Research, Project Management and other staff contributing to submissions regarding content and timelines; ensuring sections provided to Regulatory are consistent with internal submission format standards; reformat sections as necessary
• Preparing and assisting in the preparation of high quality domestic and international regulatory submissions (e.g., IND (e.g., Initial IND, Briefing documents, Annual Reports and other maintenance submissions), IMPD, CTA, BLA/MAA)
• Reviewing new regulatory guidances and other similar information, evaluating its potential impact on projects, and advising personnel from other departments regarding applicability and impact
• Providing regulatory research on new products and interacting cross-functionally to develop innovative strategies for new products
• Generating Regulatory SOPs with input from stakeholders; providing training where appropriate
• Continuing professional development by attending regulatory-related meetings, (e.g., FDA Advisory Committee meetings, conferences, workshops)
• Performing regulatory research tasks or scientific-based projects as requested
• Providing support to senior Regulatory Affairs staff as requested

QUALIFICATIONS

Education & Experience

• Bachelor’s degree in scientific discipline; advanced degree desirable
• Minimum of 5 years of Regulatory Affairs experience

Knowledge, Skills and Abilities

• Knowledgeable regarding FDA regulations and guidances as well as international regulatory guidances and requirements (e.g., ICH)
• Demonstrated experience resolving domestic and international regulatory issues
• Excellent verbal and written communication skills including ability to discuss technical information and regulatory requirements with project teams and the FDA

IF INTERESTED, PLEASE CALL CECELIA, MORRIS EXECUTIVE  SEARCH AT 240-464-0156 OR EMAIL CECELIA@MORRISEXECUTIVESEARCH.COM