REGULATORY |
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Leadership in Changing Times:
The non–technical aspects of
Regulatory Management
David Kelly, Unicus Coaching & Development
The role of the Regulatory Manager is a multi–faceted one requiring a wide variety of skills and experiences. Not only does the manager have to have a sound knowledge of the latest regulatory requirements and constantly be updating his or her knowledge base, but there are skills and expertise expected that very often have been acquired through experience rather than formal study.
Most managers in regulatory affairs will have received or undertaken studies in a related field. Usually they will have a Life Science degree and have completed a number of professional regulatory related courses. Many will be ex ‘bench scientists’ and moved into regulatory roles for personal and career development reasons. Traditionally they will have been people renowned for their attention to detail and perhaps their project management skills. As they progress their careers and move into management they are faced with a diversity of expectations for which they may have had little or no training.
Today’s regulatory affairs manager is expected to be not only a professional expert but also a good negotiator, a strategic thinker and planner, a financial wizard managing often very large budgets, a bit of a marketeer and last but not least a people manager. And it is the last of these disciplines that can cause the most amount of angst for the Regulatory Manager. As with many professionals they gain promotion to a management role based on their professional expertise and then have to learn quickly a complete set of new skills or face increased stress levels and often ‘failure’. How many great footballers have moved into management and found it really not for them? How many good actors have tried their hand at directing and decided it’s not for them?
And so good preparation and development for a manager’s role is essential – and then even with that there is the real challenge of managing or leading a team of individuals through times of increasing uncertainty and change.
THE CHANGING ENVIRONMENT
Society, organisations and individuals live in a world of constant and ever increasing rate of change. Whereas a new concept, product or business “solution” would last for a few years not so long ago, most ideas are almost obsolete before they are even fully implemented. And the pharmaceutical industry and the ‘medicines market’ is no exception. Many of you will remember when blister packs were being introduced, when generic prescribing was seen as unlikely to happen in any significant way and when User Testing of Patient Information leaflets was a concept not even dreamed about.
Along with technical and regulatory changes there are changes within people’s attitude to work. Many people see development as a right; others argue that the critical factor is work–life balance while others are looking for fully flexible working. Such attitudes are only recently being addressed and the work environment will continue to shift and change. So how does a good manager go about leading their team through uncertain and changing times, especially when one is leading a team of highly qualified and professional people. There is no quick and easy answer but there are some key concepts that will help you and your people react more positively to change.
LEADING CHANGE
When it comes to leading change many managers assume that because a change has been ‘announced’ or imposed most of their people will react negatively or at least apprehensively. It’s as well to state up front that often this is not the case. For example, one person’s fear of a takeover by another company is another person’s door of opportunity. However, let us assume that we are talking about “leading” a change that has the potential to be badly received. That it is an imposed change.
What can a good leader do to help ensure the change has the best opportunity of success? Aside from being open and honest and being available for your people there are five practical steps that effective leaders can – and do take. And the good thing is these steps apply equally to leaders of large teams as they do to leaders of small teams of only three or four.
1. Vision
As a leader you must be clear what the overriding purpose behind the change is. What is the goal? If you have been involved in creating the change this should be easy. If not, make it your business to ensure you get to know. Help your people, your team members to understand the reasons for the change. You are not trying to convince them necessarily to agree with it, or to like it. Simply to understand why! Finally you need to work with the individuals to help them create a positive vision for themselves in the future.
2. Values
As a leader it is likely that you have already agreed a set of values, a modus operandi, with your team in the past. Or perhaps your organisation has values for the entire business. In times of change these values give you a guide as to how you and your team will operate and how they will behave and treat each other.
If there are no values in place then make it a priority to discuss and agree these as soon as possible. You may want to consider integrity, respect and performance as 3 key values. So no matter what happens you agree that ‘all of us’ operate with integrity, treat one another with respect and focus on delivery! Even if a change may mean some will lose their positions, their security, their future employability will be enhanced if they can leave with heads held high, proud of their professionalism and performance. There is no shortage of demand for good Regulatory Affairs people.
3. Wherewithal
Whether it’s a change of work practices, change of role or reorganisation of your department, as a leader you have to do your utmost to give your people the wherewithal to come though the change successfully. This may be to provide them with new skills or knowledge that they may need to reach their own vision or the organisation’s vision. It certainly means providing them with regular information as to the state of play. And you need to give them the time and the scope to be listened to: many leaders see communication through times of change as a one way street. It’s not – people need to talk and need to be listened to as well. They will need time to digest what the change means for them and to think about the way ahead. They need time to realise that although they may not be able to control the change being made, they certainly can control how they react to it and how they can plan their future.
4. Motivation
As a leader you need to discover what each individual would value as an incentive to help the change succeed – even if initially they see the outcome as being less than positive for themselves. It may be some financial reward for their input to the change: it may be a form of public or private recognition. It could be getting them to take the lead in some project related to the change. Or it may be providing them with some form of counselling or coaching support. Whatever it is, as a leader you should find out what the incentive is and in line with your values and practical business needs, go some way, or all of the way, to provide it.
5. Milestones
With any change every one needs to know how it is planned to progress. What are the stages or steps towards the new situation? When these are known for the team or the organisation then each individual should have an agreed action plan. What is expected of them? When? What help may they need? Can they get it and where?
With an action plan in place each individual has a clear sense of direction and purpose. They gain a feeling of being somewhat in control of the situation which in itself is a huge positive. Most people feed back that the biggest frustration or concern or anger with any change is the feeling of helplessness, of being out of control, of having the change imposed upon them. Working with an action plan and an agreed goal removes a great deal of these negative emotions.
Success
So does this guarantee success? No, but it increases the chances of success. There may still be those who cannot or will not accept the change. You need to spend time with them – listening. And ensure to spend time with the others; otherwise it will be seen that the way to your ear is by being resistant. There will be times that what you have communicated will happen doesn’t happen! This will be even more so if you have adopted an approach of communicating as much as you can as soon as you can. So be honest – things alter, timelines slip or are brought forward. If you have lived your values and demonstrated these in your previous actions – particularly respect and integrity – the team, your people will understand.
Final Tips
As a leader in times of change you have to be many people:
- A leader – who leads by example, is a role model and lives the agreed values;
- A manager – who manages the ongoing business;
- A coach – who listens to others and helps them explore options;
- A confidante – who keeps their confidences and their concerns private;
- A professional – who never loses sight of the business while supporting their people;
- A team player – who seeks out help and support for you.
As a leader you’re as well to become a master of leading change. There’s nothing more sure than you’ll need to for, as Heraclites supposedly said, “Nothing endures but change.”
THE ROLE REDEFINED
As a Regulatory Manager you need to develop the attributes of the eagle. Not only do you need to be able to soar high above the organisation and scan the horizon for looming changes, to be able to see into the distance and anticipate what’s coming, you also need to have the attention to detail of what’s going on close to you and around you in your team. Who needs a bit more leeway, who needs a little more encouragement, what is the impact of some new piece of legislation on your own and the team’s workload? What new skills do we need to be developing?
Leading through time of change is demanding for everyone but even more so when fulfilling a role within Regulatory Affairs, which in the end is a truly critical function for any pharmaceutical company’s survival.
