By Rashmi Dodia, MS – MMS Regulatory Operations Specialist
For flawless submissions rooted in quality from the early stages of conception through successful execution and submission, a Regulatory Operations Specialist (ROS) can be considered the Captain of the Ship. Their role is not as simple as many consider it to be. A submission is not about attaching pre-written documents to an email and hitting the “Send” button on the FDA Gateway. It involves strategy and efficient operational skills for compilation, and minimizing the chances of errors that can involve tremendous amounts of rework.
One could liken the role of a ROS to the post-production responsibilities of a movie producer – they need to make sure the final submission is a polished and a truly finished product! They are the ones that put all the pieces together, make sure everything is in the right place per the Agency requirements, ensure all functionalities of the final output xml or PDF work, and present a true submission “package.” They are the last, critical step in finalizing a submission. Their key tasks include laying out a detailed project plan for their submission in accordance with the eCTD structure, publishing submission-ready documents, compiling and publishing submissions using a publishing tool, corresponding with the Health Agencies (HA) about eCTD publishing specifications, and oversight of document management for effective tracking, versioning and archiving of regulatory documents. All of these tasks require immense patience, the ability to multitask, and a sound knowledge of regulatory requirements and expectations of the concerned HA. Even a minor oversight on the part of an ROS can lead to submissions being rejected.
Here are 10 key attributes of an experienced ROS:
1) Knowledge of regulatory modules and structure: ROS’s start their work with understanding the type of application they are working on. Their deliverables can range from FDA IND and NDA applications/amendments to CTAs or MAAs in different parts of the world. They have to dig deep and chalk out an action plan.
2) In-Depth Knowledge of CFRs and Guidances: Just having the knowledge of application types and procedures is not enough; use of CFRs and guidances is an indispensable part of the ROS’s daily routine. The more familiar they are with the regulations, the easier it is to reference them. All work on an application has to be compliant with the guidance at every stage.
3) Attention to Detail and Quality: Once they have charted out a plan conducive to their submission type, the next step is to ensure all the required documents are procured from the right sources and published according to submission-ready standards. A ROS has to have a keen eye for detail, and ensure that the formatting and finalization of documents is done as per client and internal quality standards. It may require conducting quality checks on a document at different stages to ensure the highest level of quality is met.
4) Effective Document Management: In the process of putting together a submission, there is a lot of back and forth of documents between the client, external vendors, strategists, medical writers, and document specialists. In such a scenario, a ROS has to ensure proper versioning of documents through effective document, including incorporating additional updates/ last minute changes. The ROS also has to make certain the deliverables stay on track. They should have the ability to speak up, and more importantly, they must ensure the job gets done.
5) Expert Knowledge of the Publishing Tool: This is one of the more important tasks of a ROS on a daily basis. There is a huge learning curve involved in this area. A ROS has to learn how to import documents into the publishing system. They have to compile the submission patiently, and that involves a lot of guidance referencing in order to place the components in their correct module in the submission outline, name them as per FDA conventions, version them appropriately, select the right lifecycle operators for documents, and manage datasets and program files. When finally everything seems about right, they can publish the submission, expecting the least number of errors. But on occasion, they are in for a surprise as the validation tool is programmed as per FDA guidances to catch anything that seems out of place. The important thing is to submit a quality submission to the HA in time.
6) Effective Communication with HA: At times there may be questions regarding the HA preferences for certain document types or placement of documents in the eCTD outline, or other concerns like datasets exceeding the FDA specified size limit. In these unexpected situations, the wisest thing to do is contact the Agency with questions and concerns and take action accordingly.
7) Thinking Outside of the Box: Although regulations and guidances provide a road map, there are “gray” areas that require interpretation in almost every major submission. There are instances when the “go-to process” will not work, and a ROS is required to creatively think outside of the box to successfully complete the project. Additionally, it is a prime responsibility of a ROS to document such instances and experiences for future reference.
8) Streamline and Improve Current Processes: The learning curve never ends for a ROS and they always have to be open to new challenges and opportunities. One of their main responsibilities is to create workflows, SOPs, and guidances for newer projects that can be referenced in the future for similar work. They need to keep streamlining and improving on the current methods and processes as they continue to learn better ways of doing things.
9) Keeping Track of Submission Timelines: A ROS has to keep a track of all the submission activities and ensure they are on top of their game. They need to have timely communication with the strategists and clients to ensure everything is moving along smoothly and none of the submission timelines are getting missed. Knowledge of regulatory timelines and framework is a key factor in ensuring all required documents and forms reach the agency on time.Awareness of Client Expectations: It is important to meet the HA timelines as well as meet client expectations. A ROS has to ensure their job is well done, take into consideration and accommodate client requests (even if they are last minute), and look for ways to provide excellent service to surpass their expectations. Wowing the customer with timely support is a part of their daily responsibilities. Looking for ways to better support clients is a vital part of the MMS business model. Since Regulatory Operational tasks usually begin when the other departments have completed their work, the final responsibility of a successful submission is carried on their shoulders