Regulatory Affairs Consultant, Orphan Drug

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We are looking for a Regulatory Affairs Consultant to support several ongoing regulatory submission programs. The support will vary based on the timing of each program but on average could require about 10 hours per week. This role is remote.

• Work closely with Pharmatech and our client’s project team to be responsible for the execution of the regulatory operations related to the Lorenz docu Bridge 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 docu Bridge TWO submission management software

• 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 Lorenz docu Bridge 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.

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