The manner in which a company interacts with the Agency can determine the fate of that company. The primary purposes of a Regulatory Affairs department are to ensure that all interactions are managed carefully, to ensure a fair assessment of data, and to ensure compliance with each and every pertinent regulation. Consultants are called in. Histories are reviewed. Meetings are held.
Rehearsals begin days before the meeting.
Dress is decided. Seating arrangements are reviewed. Every possible question, potential sticking point, contingency, blunder, agreement, success, and failure are reviewed, recorded, reviewed again, and discussed. Any modest success I've achieved has been due to the nerd factor. If this tale of leveraging the nerd factor insults or annoys, I apologize.