• Coordinate the planning, scheduling, preparation, reviewing and assembling of regulatory projects and submissions, including developing the content and format of regulatory submissions.
• Provide assistance with responses to regulatory agency questions.
• Coordinate post IND approval activities (annual reports, adverse event reporting, registrations, etc.)
• Provide support to clinical, quality, and other scientific development disciplines to assure that documentation conforms to applicable regulations and guidelines.
• Maintain working knowledge of regulatory submissions, understanding of product chemistries, manufacturing processes and analytical packages and their regulatory implication.
• Establish and maintain policies and procedures to ensure regulatory compliance with government agencies and international Good Clinical Practice (GCP).
• Provide advice and suggest strategies as required to facilitate regulatory actions. Provide timely review of technical data, labeling, promotional material and any other collateral documents that are subject to regulatory control.
• Provide timely information to regulatory bodies that may be required for adverse events, recalls or other such activities. Supervise as needed, any of the activities.
• Maintain a thorough and up-to-date knowledge of current FDA regulations, industry guidance literature and licensing requirements.
• Work closely with Project Managers on a routine basis to assure transfer of information in a timely manner.
• Review and approve product labeling and advertising for compliance to applicable regulatory requirements. 

Requirements:

• Minimum of Bachelor's Degree in Life or Engineering Science; advanced degree preferred.
• 6+ years experience as a multi-functional Regulatory Affairs professional and quality systems with at least 4 years in a senior managerial capacity.
• Experience in providing regulatory direction to development, preclinical and clinical evaluation, manufacturing, and marketing of biological products, including experience with IND and NDA application requirements.
• Comprehensive knowledge of U.S., European and international regulations and standards relating to biopharmaceuticals.
• IND submission experience required for regulatory position focusing on FDA/CDER compliance.
• Knowledge of the clinical application of recombinant proteins, as applicable.
• Knowledge of biopharmaceutical testing methods and statistics, as applicable.
• Regulatory affairs certification (RAC) preferred.
• Ability to think strategically, exercise independent judgment and problem solve.
• Ability to independently identify compliance risks and escalate if necessary.
• High analytical evaluation skills.
• Good negotiation skills.
• Demonstrated positive communication and human relation skills.
• Excellent communication (both verbal and written).
• Excellent people and project management skills, with ability to prioritize, handling several projects concurrently.
• Proficient in Windows environment and with Microsoft programs.