What are the responsibilities and job description for the Regulatory Affairs Consultant, Orphan Drug position at Pharmatech Associates?
We are looking for a Regulatory Affairs Consultant to support several ongoing regulatory submission programs. The support will vary based upon the timings of each program but on average could require about 10 hours per week. This role is remote.
Job Duties
- Work closely with Pharmatech and our client’s project team to be responsible for the execution of the regulatory operations related to the Lorenz docuBridge TWO submission management software relating to FDA communication and submission of regulatory documentation.
- Fast Track and Orphan Drug applications for regulatory submissions to the FDA (or other regulatory agencies)
- Participate as part of internal regulatory team to define and execute the regulatory strategy and focus for each program
- Support the preparation of briefing packages, and regulatory submission documents as needed, via the Lorenz docuBridge TWO submission management software
Education and Qualifications
- Advanced degree from accredited college or university in science, biomedical engineering, plus a minimum of 4 years of experience in Filing Global Regulatory Applications for pharmaceutical and Biotech products using the Lorenz docuBridge TWO submission management software
Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.
