Challenges And Barriers Facing Regulatory Affairs

The task for regulatory professionals in the years ahead – and the pressure they face to do it well – is enormous. Workloads are increasing dramatically as they struggle to triage competing requests, adjust processes to accommodate new regulations, and keep on top of paperwork. Simultaneously, regulatory teams are being asked to support new business priorities like market and product expansion and ambitious sustainability goals, all while increasing transparency.

Regulatory affairs teams are tasked with supporting both expansion and product maintenance – adding to their workloads and stress.

Regulatory professionals report that existing product maintenance (45%) and global expansions (43%) will create some of the biggest regulatory challenges this year for their teams.

They also contend that increasing regulatory complexity (40%), manufacturing and sourcing flexibility (40%), transparency and sustainability (39%), and regulatory expertise to support new product categories (36%) will be major challenges.

Current Major Regulatory Challenges

Businesses are looking to expand their offerings and move into new markets, piling work onto regulatory affairs teams as they fight to keep up with their existing responsibilities.

Professionals report the greatest sources of increased workloads for their team are expanding product lines (51%) and global expansion (47%). Almost 50% report that they are getting additional work from brand maintenance (reformulation, rebranding) and M&A and regulatory updates.

Sources of Increased Workload

The growing ambitions of corporate sustainability efforts at many organizations today means that regulatory professionals are now tasked with more holistic product stewardship – in addition to their traditional responsibilities.

More than 50% of regulatory professionals believe that their company’s sustainability efforts are adding to their workload. Their growing list of responsibilities include tracking chemicals of concern, achieving compliance with 3rd-party certifications, ingredient transparency, raw material assessments, and sustainability goal tracking.

3 in 5

Regulatory Professionals Believe that their Company's Sustainability Efforts are Adding to their Workload

Top Sustainability Efforts Adding To Workloads

In light of these growing demands, regulatory professionals believe that balancing it all and staying agile in the face of shifting priorities will be their greatest challenge in the medium-term.

Looking ahead to the next 12-18 months, regulatory professionals have identified several areas that will continue to impact their team’s responsibilities and resources. Top challenges are all related to juggling their growing workloads, including balancing competing requests, managing team commitments and tasks, adjusting processes and expectations with new regulations or partnerships, and implementing and enforcing policies to adhere to new and existing guidance.

Administrative duties are also adding to their plate, such as tracking priorities and alignment with regulatory activities.

This is in line with with past Regulatory Trends Studies, in which regulatory professionals indicated that major sources of increased work included adjusting processes/expectations (31%), managing team commitments and tasks (25%), and tracking priorities and alignment (24%).

Top Challenges For Regulatory Teams

Managing internal and external stakeholders while keeping timelines intact is another key challenge.

Regulatory professionals indicate some of their top concerns when managing product dossiers or technical files include tracking internal stakeholders’ input into the submission (36%), difficulty managing launch timelines (34%), and keeping up with the complexities of regulatory requirements (33%).

In addition, 3 in 10 are worried about building best practices to enable efficiency, lacking resources to support all business initiatives, and tracking launch updates to products and dates (30% each).