In highly regulated industries such as pharmaceuticals, medical devices, and chemicals, a Contract RP plays a crucial role in ensuring that products meet all legal, regulatory, and quality requirements. RP’s are the linchpins between a company’s operations and the regulatory bodies that oversee compliance. Whether they are managing product batches, overseeing audits, or liaising with regulatory authorities, the Contract RP’s role is multifaceted and dynamic. But what does a day in their life really look like? Let’s dive into the typical schedule of a Contract RP and explore the responsibilities that come with this critical role.

Morning: Reviewing Compliance and Regulatory Requirements

A Contract RP’s day usually begins early, as they review key emails, messages, and updates from the previous day. The morning is often spent prioritizing tasks and reviewing any urgent notifications from regulatory agencies, clients, or internal teams. Given that a Contract RP must stay up-to-date with changing laws and regulations, the first task of the day might involve reading any new updates or advisories issued by regulatory bodies i.e. MHRA, HPRA or notified bodies.

Compliance is non-negotiable, and the Contract RP must ensure that any new changes are incorporated into the company’s ongoing operations .

A typical morning might also include a review of batch records to authorize RPi release, review of returned products to decide final disposition of products and so on. The Contract RP will ensure that all necessary documentation is in place to comply with regulatory requirements.

Mid-Morning: Internal Coordination and Quality Control

By mid-morning, a Contract RP typically shifts focus to ‘internal coordination. They might have a scheduled meeting with key stakeholders in the quality assurance (QA) or quality teams. These meetings are essential to ensure that products are being manufactured, tested, and stored in compliance with established protocols. The RP needs to ensure that the internal teams are aligned on timelines, safety standards, and regulatory requirements.

For instance, a Contract RP in the pharmaceutical industry may be overseeing the release of a batch of medication. This involves ensuring that the batch meets all ‘Good Manufacturing Practice (GMP)’ guidelines and that the batch record is complete and accurate. If any discrepancies are noted—whether in labeling, documentation, or testing results—the RP is responsible for investigating and resolving them before the product can be released.

Another common task at this stage of the day is ‘audit preparation’. A Contract RP is often tasked with preparing the company for internal or external audits, whether these are scheduled regulatory inspections or third-party assessments. This requires going through records, ensuring that all documentation is in order, and reviewing processes to identify any areas that might need improvement.

Lunchtime: Stakeholder Communication and Regulatory Liaison

Lunchtime offers a brief opportunity for the Contract RP to address routine communications with external stakeholders—whether it’s a Regulatory Authority, Contract Manufacturer, or Client. A Contract RP needs to build strong relationships with these parties, as the role involves regular interaction with agencies to ensure compliance.

Additionally, the Contract RP may spend time providing feedback or responding to questions from the Supply Chain Team or Customer Service Teams, regarding product releases, and market access requirements. They may also provide training to internal teams on regulatory changes, helping everyone stay aligned with the company’s compliance objectives.

Afternoon: Documentation Review, Risk Management, and Training

Afternoons are typically dedicated to Documentation Review, one of the most critical aspects of a Contract RP’s role. This could involve ensuring that all documentation—such as Certificates of Analysis (COA), batch records and Non-Conformance reports—meet the required standards .

Risk management is another key focus of the day. The Contract RP is responsible for identifying potential risks in the production or distribution process. They might conduct a risk assessment for an upcoming product release or review any deviations that have occurred in the distribution process. If any deviations or non-conformances are found, the RP must oversee the investigation, root-cause analysis, and corrective actions to prevent recurrence.

A Contract RP may also be involved in Product Recalls or Post market surveillance. If there are any concerns regarding product quality or safety post-launch, the RP is tasked with managing the situation, including overseeing investigations, reporting to regulatory bodies, and ensuring that corrective actions are implemented swiftly.

Another important  task is organizing internal training, to ensure that employees are kept up-to-date on the latest regulatory requirements or compliance standards. The RP may need to create or update training materials and ensure that staff are well-informed about best practices in product safety, quality control, and documentation.

Late Afternoon: Problem-Solving and Planning

As the day winds down the Contract RP addresses any urgent issues that have come up during the day. This might include issues related to receipted stock which has incurred an issue during transit, or liaising with external vendors or contractors to resolve issues related to manufacturing.

Finally, before signing off, the Contract RP takes time to plan for the next day—reviewing any upcoming deadlines, regulatory changes, or meetings that need attention. Ensuring that all compliance tasks are on track is a constant balancing act, and preparation is key to staying ahead of the curve.

While the specific tasks and responsibilities of a Contract Responsible Person can vary depending on the industry, one thing remains constant: they are essential for ensuring that the products are safe, effective, and compliant with regulations. Their role might be invisible to consumers, but it’s vital to the integrity and success of the organization they support.

The Contract RP Role within Callisto is very diverse and unique as a Contract RP can be named on more than one license. Each day can vary from the previous day inclusive of Client site visits, external site visits or a day spent at the Callisto office amongst the various teams and being able to learn from day to day scenarios that fellow colleagues may encounter.