Maximizing efficiency in pharmaceutical regulatory affairs with staff augmentation

Executive summary/abstract

Staff augmentation offers a strategic solution for pharmaceutical companies looking to efficiently manage regulatory affairs, irrespective of the degree of outsourcing or offshoring within the operating model.

By leveraging external expertise on a flexible basis, companies can streamline their regulatory processes, reduce time-to-market, and maintain compliance without overextending their internal teams.

Whilst the perception often is that staff augmentation purely fills short-term resource gaps, navigating the complexities of global regulatory requirements can feel like a never-ending challenge.

Bringing in external staff can provide valuable insight into industry trends, and leverage partner organization capabilities and expertise.

To maximize the value of this approach, there are several elements to consider.

Firstly, establishing the needs and requirements regularly within the organization is crucial to planning efficient sourcing and onboarding.

Building a trusted relationship with a partner with the requisite expertise in regulatory affairs enables an accurate assessment of the skills and experience required, but also can provide additional responsiveness and support, and routinely assessing performance allows for adjustments in the process and improving future outcomes.

1. The growing complexity of pharmaceutical regulatory affairs

1.1 Navigating the regulatory maze - The pharmaceutical industry operates in a highly regulated environment, with guidelines that vary not only by region but also by product type and therapeutic area. Regulatory agencies including FDA, EMA, and others are relentless in updating their requirements and guidance to keep pace with scientific and technological advancements. For instance, the rise of digital health technologies has introduced a new wave of regulatory challenges across multiple geographies.

1.2 Impact on pharmaceutical companies - The consequences of failing to comply with these regulations can be severe. In recent years, several major pharmaceutical companies have faced significant fines, supply chain disruption, and missed market opportunities due to non-compliance issues, leading to substantial financial losses and delays in product launches. There are numerous examples through recent history where a Company experienced delay in bringing their new Covid vaccine to market, resulting in a loss of millions in potential revenue.

2. Understanding staff augmentation in regulatory affairs

2.1 What is staff augmentation? - Staff augmentation is the hiring of external resources alongside the current permanent team as a response to a shortage in specific skills, a project need, or to achieve a goal on an as-needed basis.

There are different means of acquiring additional staff members.

Within the existing organization, staff may be redeployed through temporary assignment, or through training new staff, before returning to their original roles.

Sourcing staff externally can be done directly through the organization's talent acquisition (TA) function, recruitment agencies, or specialist consultancy firms. An organization’s TA group would need an understanding of the specific function and market to be effective but can be the most cost-efficient means of sourcing freelance staff.

Recruitment agencies can be cheaper, but agents lack the specialist knowledge to match skills and competencies to the needs of the task. Specialist consultancies have a deeper understanding of the requisite skillset, the hiring market, and the needs of specific projects. This specialism and expertise come with an expected premium.

Staff augmentation is a flexible staffing strategy that allows companies to bring in external expertise. Unlike traditional hiring, which involves a long-term commitment to new employees, or consulting, which typically focuses on advisory services, staff augmentation provides specialized professionals who can integrate seamlessly into existing teams to meet specific project needs.

This model is particularly advantageous for regulatory affairs, where the demand for expertise can fluctuate based on the stage of drug development or changes in regulatory requirements.

2.2 Types of expertise available through staff augmentation - Pharmaceutical companies can leverage staff augmentation to access a wide range of regulatory expertise. This includes regulatory affairs specialists who are well-versed in global submission requirements, post-approval specialists who ensure adherence to the latest guidelines, and publishing/submission management experts who handle the critical task of preparing and submitting regulatory documentation. Having the right expertise at the right time can make all the difference in meeting regulatory deadlines and avoiding costly delays.

3. Benefits of staff augmentation for pharmaceutical regulatory affairs

3.1 Flexibility and scalability - One of the key benefits of staff augmentation is its flexibility. Pharmaceutical companies can scale their regulatory teams up or down based on project demands.

For instance, during a new drug application (NDA) submission, for M&A activity, or an expected peak of workload to manage a worldwide manufacturing rationalization, a company might need additional regulatory specialists to manage such projects. Once the submission is complete, the company can reduce the team size without the long-term commitment associated with full-time hires.

3.2 Cost-effective access to expertise - Hiring and training full-time regulatory professionals can be time-consuming and expensive. With staff augmentation, companies only pay for the expertise they need, when they need it. This model reduces overhead costs associated with full-time employees, such as benefits and training.

Additionally, it allows companies to access high-level expertise that might be too costly to maintain in-house permanently. Regulatory affairs is a specialist area that is time and cost-consuming to recruit for so partnering with a niche provider in this area pays dividends.

3.3 Faster time-to-market - Time-to-market is critical in the pharmaceutical industry. Delays in regulatory approval can result in significant financial losses, especially when a company is trying to bring a new product to market before competitors.

By augmenting their regulatory teams with experienced professionals, companies can expedite the submission and approval processes. For example, Company Y was able to reduce its NDA submission timeline by three months by bringing in additional regulatory affairs specialists during the final stages of preparation. This speed to market enables the organization to reach patients and deliver returns much faster, particularly in a competitive market situation.

4. Implementing staff augmentation in your regulatory strategy

4.1 Identifying your needs - Before implementing staff augmentation, it is essential to assess your company's specific regulatory needs. Start by identifying gaps in your current team’s expertise and capacity.

Are there upcoming projects that will require additional regulatory support? Are there areas where your team lacks specialized knowledge?

Once you have identified these needs, you can determine the type of expertise required and the duration of the engagement. Articulating this accurately to the partner organization will ensure that there are fewer mismatches in resumes or skillsets.

4.2 Best practices for integration - Successfully integrating augmented staff into your existing team is crucial for achieving desired outcomes. Begin by clearly defining roles and responsibilities to avoid duplication of efforts or gaps in coverage.

Effective communication is key - regular check-ins and updates ensure that everyone is aligned on project goals and timelines. Additionally, consider appointing a project manager to oversee the integration process and ensure that augmented staff are fully supported and utilized.

5. Case studies and success stories

Case study 1: Company A, a mid-sized pharmaceutical firm, faced challenges with the regulatory submission of a new biologic.

By leveraging staff augmentation, they brought in a team of regulatory affairs specialists with experience in biologics. This additional expertise allowed them to navigate the complex submission process successfully, resulting in a faster approval and subsequent market launch.

Case study 2: Company B, a global pharmaceutical company, needed to quickly adapt to new regulatory requirements in multiple regions.

Through staff augmentation, they accessed local regulatory experts who provided critical insights and ensured compliance with regional guidelines. This approach enabled the company to maintain compliance without overburdening its internal teams.

6. Conclusions - Navigating the complexities of pharmaceutical regulatory affairs requires specialized expertise and the ability to adapt quickly to changing requirements. Staff augmentation offers a strategic solution for companies looking to optimize their regulatory processes, reduce costs, and accelerate time-to-market.

If your company is facing regulatory challenges, consider how staff augmentation could help you meet your goals.
Contact us today to discuss your needs and explore how our team of regulatory experts can support your projects.

Paul Kuiken is Vice President of Advisory Practice at G&L Healthcare Advisors.