Regulatory changes are common in the life sciences sector as it becomes necessary to adapt to innovations in modern technology, to comply with data privacy laws and to safeguard the long-term health of clinical trial participants. However, complying with these changes is not always simple.

In this article, I will discuss 5 proactive strategies for staying ahead of regulatory changes. By embracing a regulatory change management process such as this, it becomes possible to pre-empt upcoming changes and adapt quickly and efficiently to any changes that occur, thus protecting your business from litigation or reputational harm.

Potential sources of regulatory change information are industry associations such as the Association of the British Pharmaceutical Industry [1], media and specialised content providers, so whilst it may not feel like a value-added activity, regularly reviewing newsletters and attending seminars and conferences can deliver a significant benefit.

Businesses can also employ automation technology to scour the internet for particular keywords of interest, directing a business' attention to any potential regulatory changes of which they should be aware.

Business data should be stored in a manner that is easy to categorise, search, update and maintain. When language and terminology are consistent throughout the organisation, it is possible to set up a rigorous compliance framework [2] to which the entire business can adhere.

Many Governance, Risk and Compliance (GRC) software tools are designed to allow businesses to implement industry-standard language, increasing their ability to not only streamline their own management of business data, but easing the manner in which they can search for changes and updates outwit their own business datasets.

Embedding regulatory change management responsibilities into an individual's role and responsibilities not only ensures that a designated individual has specific responsibilities for all elements of compliance activities but is a powerful method by which a business nurtures a pipeline of professional talent. 

When a dedicated individual is nominated as a compliance officer, they assume additional levels of responsibility, enhancing their capabilities. This empowers them to engage with experts within and outside of the business and gives them the opportunity to brief senior members of staff and propose appropriate actions. 

By enabling an existing, talented member of staff to expand their role in this way, they develop greater levels of engagement with the business and its outputs, delivering a benefit for the business as well as supercharging their own personal and professional development.

Every potential regulatory change must be assessed to determine the impact that it may have on the operation of the organisation. It is essential that this impact assessment considers the risks, mitigations, controls, policy and procedure changes and training needs that will need to be addressed or implemented should the change be enacted.

The designated individual nominated as the organisation's lead for regulatory change management should lead on impact assessments, gathering together any subject matter experts whose input is required to determine the true impact that each change would have on the organisation and who can support the implementation of any new measures.

When the different functional departments within a business collaborate in this manner, it is possible to develop a holistic view as to the impact of any changes as well as to plan the most appropriate and logical manner in which to address them.

Following a cross-department review of potential regulatory changes, it is important that an action plan is developed for implementation, with action owners identified and a clear timescale agreed upon. This must deliver ahead of the regulatory change deadline to ensure that the business complies with all applicable legislation and regulations.

The regulatory change manager must be responsible for notifying action owners of their responsibilities and for monitoring their progress in achieving them. They should develop appropriate reporting mechanisms for tracking progress and identifying risks that may impact the timescales. 

They will also retain responsibility for updating information management systems and cascading information relating to the changes to the entirety of the organisation, ensuring that any department affected by the changes understands their new responsibilities as well as the penalties for failing to comply.

The onboarding process must be as slick as possible, recognising that most candidates will be required to give a month's notice to their current employer, who may try to sway their decision during this time.

Maintain communication, provide them with details of events and schedules for their first few days or weeks, allow them to ask questions and communicate concerns and ensure that they know where and to whom to report on their first day.

By improving performance in these three areas, the risk of dropouts will decrease. There is so much to consider when running a life science recruitment drive and selecting a talent partner such as Circle Life Sciences can enhance the experience for you and your candidates. Our talent management solutions offer tried and tested recruitment processes, excellent candidate communication and expert support for your team. Contact us today to find out how we can help your business minimise the risk of dropouts.

Regulatory change management is a distinct function which, in the life sciences sector, can feel like an all-consuming role. For businesses wishing to stay ahead of any and all changes, nominating a dedicated individual to fulfil this role is a sound business decision that will deliver lasting benefits.

If your existing workforce is entirely committed on the objective to accelerate your life science breakthrough and you need to recruit a new member of staff to take on this role, please contact Circle Life Sciences today. With our support, you will secure a guaranteed successful hire, whether on a permanent or temporary basis as best meets your requirements. 

We can introduce you to an experienced interim regulatory change manager who can not only fill an essential gap in your workforce but who can help to upskill your nominated individual, delivering a long-term benefit to a loyal member of staff whilst supporting your business in implementing effective processes and procedures for managing regulatory change.

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[1] https://www.linkedin.com/pulse/3-steps-creating-compliance-framework-marissa-mccauley/

[2] https://www.linkedin.com/pulse/3-steps-creating-compliance-framework-marissa-mccauley/