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European Pharmaceutical Contractor

Legal Studies

Signs of the times bode well for regulatory affairs (RA) professionals within the life sciences industry. Companies are facing more stringent regulations and an increasingly globalised market governed by local – and continually changing – laws.

Collaboration between industry and authorities is growing, more licensing deals are being struck, and companies have an ever-pressing need to pass through regulatory hoops quickly. This all suggests a deepening dependence on what the RA function can deliver.

Strategic Partner

Perhaps the most encouraging news is that in most situations and organisations, RA is no longer viewed as an obstruction to achieving the company’s goals, but rather as a strategic partner in the business (1). Leadership generally recognises that RA’s guidance and oversight can play a critical role not only in speeding and smoothing the approval process, but also in ensuring successful development outcomes, reducing risk, and improving the efficiency of multiple processes along the product lifecycle.

Yet there is a catch. The notion that RA is ‘the place to be’ presupposes that professionals in the field are equipped to add value beyond performing operational tasks. Those who develop a strategic mindset and demonstrate that they can contribute in meaningful ways to the business’s goals do stand to advance within the organisation. However, those who do not may find that the increased demands on RA will not necessarily translate into career progression. Purely operational tasks can be, and frequently are, outsourced. Indeed, a 2013 study revealed that 68 per cent of surveyed companies are outsourcing some portion of RA (2).

The pathway to job security and advancement in RA is the same as it is for people in any cost centre: make yourself indispensable by contributing insight, ideas and advice that offer a material difference to the organisation.

Skillsets That Add Value

Any RA professional within the life sciences industry is expected to be familiar with the relevant regulations and to have an understanding of scientific innovation. That knowledge naturally becomes more comprehensive and global over time. The characteristics that set the best and brightest apart – and mark them for more strategic roles – include the following:

  • A solid understanding of the overall business – its processes, challenges and commercial environment
  • Strong communication skills sufficient to explain to senior management the impact of regulation on the business, as well as to be able to make and justify recommendations. Moreover, business leaders tend to appreciate RA professionals who willingly educate others
  • Project management skills to oversee complex projects having multiple, simultaneous work streams and involving international, matrixed teams
  • Negotiation and persuasion skills to effectively work with cross-functional teams and regulatory authorities to address ‘grey areas’ and resolve issues
  • Analytical and interpretive skills to identify areas within regulations that are open to interpretation in a way that may serve the business’s interests and smooth the regulatory path
R&D Phase

RA has a strategic role to play during R&D, beginning at the very earliest stages. Even before first-in-man studies, RA can help in setting expectations for a potential product – input that can be factored into go/ no-go decisions.

RA can help developers understand the current and future business environment and think through the implications. What precedents have been established in the competitive set? Where are the competitive products in their exclusivity period? What issues might arise related to the target population? What, for example, might be the special requirements for a paediatric indication? If the product is novel, what strategies could be considered to gain marketing approval quickly – for example, should the company seek an orphan drug designation?

Once a compound moves to clinical trials, RA should be consulted to ensure that the study protocol will conform to regulations and produce the components necessary to complete the product’s application for marketing approval.

Approval Phase

As professionals in RA assume greater responsibility in the organisation, their span of oversight typically broadens from a single market to multiple markets, and their project management responsibilities expand accordingly.

Increasingly, RA staff are expected to think critically, even innovatively, about the content of documents designed for regulatory review. Is the case for the drug being made as accurately and convincingly as possible? Does the data fully support the product positioning? Where might there be gaps, and could they be justified? What aspects require a stronger defence? Have the right literature references been used?

The ultimate strategic responsibility related to regulatory submissions is, of course, masterminding the overall plan for traversing the pathway to approval. This entails taking into account complex global dimensions of the market and of company capabilities and interdependencies in order to devise the most effective and efficient approach to registration.

Post-Approval 

RA professionals work with colleagues in other functions at every stage of the product lifecycle, but perhaps the level of collaboration is most pronounced in the post-approval (or preparing for marketing) phase. Many functions – from R&D, quality assurance, logistics, compliance and marketing – all coalesce to usher a product into the market and ensure its ongoing success.

At this stage, RA professionals have the opportunity to do more than ‘police’ compliance; they can, and should, serve as consultants to their partners in marketing and manufacturing, offering strategic insight that can affect their respective approaches.

In addition, those in the early phase of their career in regulatory intelligence are likely to be focused on monitoring and recording changing regulations. As they mature in their profession, people in this area should be able to use their intimate knowledge of regulations to detect trends in the changing landscape and offer proactive guidance to the business.

Business Leadership

A successful career in RA necessarily has its foundations in a thorough understanding of regulations governing product development, registration, manufacturing and marketing. But it does not end there. Life sciences organisations need RA professionals capable of participating in – and influencing – some of the most significant business decisions they make in the life of a product.

As such, they need to develop the analytical skills to identify both opportunities and pitfalls, the ability to share their knowledge and communicate positions clearly, plus the confidence to provide guidance to the highest levels within corporations. RA professionals who do this will elevate themselves to strategists and business leaders.

References

1. Keramidas, S, FASAE, CAE, Interview, Which jobs are in greatest demand. Visit: www.about.com

2. Percentage of pharmaceutical companies outsourcing regulatory affairs budgets increases to 68%, Cutting Edge Information, 9th January 2013

3. Pritchett and Price, Culture Shift: The Employee Handbook for Changing Corporate Culture


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Preeya Beczek has more than 13 years of RA experience in contract research organisations (CROs) and within the chemical and pharmaceutical industry. Prior to joining Pharm-Olam, Preeya was working in regulatory consulting at a large CRO. She has successfully managed various teams across regions for marketing authorisation applications, scientific advice, licence maintenance, clinical development planning, clinical trial applications, product labelling and process improvement initiatives. Preeya holds a BSc in Chemistry and Management Studies and an MSc in Environmental Strategy from the University of Surrey, UK. She is also a Green Belt in Lean Six Sigma.

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