The Global Regulatory Affairs Specialist works with a team of regulatory affairs professionals to ensure GEHC establishes best practices within the assigned area of responsibility.
- Support continuous improvement activities, including such areas as regulatory procedure development and documentation, standards compliance, and metrics development and implementation.
- Support regulatory compliance and optimization of quality system procedures relating to new product registration submissions and post market reporting through the development, maintenance and improvement of documented processes.
- Support regulatory inspections as required.
- Executes regulatory activities for team members or projects in accordance with applicable regulations and guidelines under supervision.
- Knowledge of FDA submission requirements.
- Prepares, review and works with publishing group in submissions of INDs, NDAs, CTAs, IMPDs
- Data entry into internal tracking systems.
- Prepares information for annual reports for assigned projects.
- Interact effectively with functional business units in order to coordinate and facilitate documentation required for submissions, ensuring that timelines are met.
- Assure timely submissions and expeditious approvals.
Quality Specific Goals:
1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
2. Complete all planned Quality & Compliance training within the defined deadlines
3. Identify and report any quality or compliance concerns and take immediate corrective action as required.
4. Maintain up-to-date knowledge and understanding of current regulatory requirements within area of responsibility
1. Bachelor's Degree (or international equivalent) in a related field such as: Regulatory Affairs, Biologics, Pharmaceuticals, Biotechnology, Biomedical Engineering, Biology, Chemistry, English (with a technical writing emphasis), Legal Studies, Law, Nursing, Physician Assistance, Pharmaceutical Science, Pharmacy OR minimum of 4 years progressive regulatory affairs experience in pharmaceutical industry or medical product regulation agencies, including knowledge and experience applying drug laws and regulations
2. Strong analytical skills
3. Ability to work in a team environment with minimal supervision on projects and activities
4. Ability to prioritize, plan & evaluate deliverables
5. Knowledge & experience conducting scientific, regulatory, legal, or business research.
Additional Eligibility Qualifications: GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.
* Excellent verbal and written communication and presentation skills with the ability to communicate in English in an easy to understand manner
* Radiopharmaceutical, biologics, or biotechnology product experience, in addition to pharmaceutical.