GI Alliance, Department of Research and Education is seeking an experienced Director of Regulatory Affairs.
Position purpose
The Director of Regulatory Affairs will have responsibility for all regulatory activities in the Department of Research and Education. The role reports to the Senior Research Director with strong alignment to the Senior Medical Director. The incumbent will proactively develop, implement and deliver strategies, programs and material that supports the execution of research objectives within the Department of Research and Education.
Responsibilities/Duties/Functions/Tasks:
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Responsible for all domestic and international regulatory agency notifications and registration submissions and correspondence
- Oversee 3rd party relationships to achieve notification and registrations
- Monitor and assess impact of relevant regulations, guidance, and current regulatory environment and communicate potential issues to management
- Provide guidance to research sites and internal concerning inquiries related to regulations and/or other regulatory related topics
- Facilitate and participate in meetings and inspections with regulatory authorities on behalf of the Department of Research and Education; in particular, act as the primary liaison with sponsors on regulatory-related topics
- Direct and support the separate Regulatory Teams to ensure that all submission milestones and regulatory goals are met
- Maintain positive departmental morale by hiring effective staff, ensuring adequate training, establishing ongoing responsibilities and objectives, monitoring performance and providing feedback
- Collaborate and communicate cross-functionally with Quality Assurance and Operations teams to maintain a positive and optimal work environment
- Provide general direction, tactical objectives, and functional plans for execution of Regulatory Affairs
- Develop, communicate, and track goals necessary to the success of Regulatory Affairs within the Department of Research and Education, as it relates to the success of the Department of Research and Education
- Support product and business acquisitions in relation to regulatory requirements and product acquisition and transfer
- Other duties as assigned
Education: Bachelor’s degree in a science-oriented field of study (e.g. Biology, Chemistry, etc.). MBA preferred.
Experience: Minimum 8 years of professional experience working in the Pharmaceutical, Biotech, and/or Life Sciences industries. 5+ years of experience directly in Regulatory Affairs
Additional Qualifications: Experience working and liaison with FDA and other health agencies to ensure timely regulatory approvals.
Performance Requirements:
- Excellent proficiency in utilizing internet, website, social media platforms, etc. to deliver messaging aligned with organization objectives.
- Excellent communication, writing, presentation and networking skills.
- Willingness to occasionally travel and work outside of normal business hours as role/position requires.
- Proficient technical (computer) skills.
- Ability to multi-task and prioritize.
- Self-motivated with initiative.
- Strong sense of ethics.
Please Note: All job offers are contingent on the successful completion of pre-employment criminal history check.
NOTE: ALL APPLICATIONS MUST BE COMPLETED IN FULL FOR CONSIDERATION.
No phone calls or agencies, please.
EEO/AA-M/F/disabled/protected veteran