Driving A Culture of Collaboration to Succeed in Improving Engagement With All The Relevant Stakeholders

An interview with one of the speakers for our 3rd Annual Pharmaceutical Regulatory Affairs Summit on 10th - 11th May 2023 in Vienna.

Disclaimer: Please note that the speaker’s interview is based on their own experience and view and does not engage the one of Takeda under any circumstances.

According to your experience, what are the key skills required for being a successful International Advertising and Promotions Regulatory Affairs Professional?

That is a very good question and I would like to highlight the notion of Business Partner here. For me, being successful in this function requires, above all, positioning oneself as a Business Partner with our cross-functional team partners (commercial, medical, legal, etc).

Concretely, it means that the idea is not to impose regulations, ideas or guidance but really co-create solution in collaboration with them in order to reach efficiency, quality and excellence in the deliverables. Working on bonding with the cross-functional teams is an important first step in the process and providing inputs requires to be involved in the project and understand it since its inception, rather than preventing the business to deliver it because we jump last minute and impose restrictions.

And what are the critical steps to become this trusted Business Partner with the cross-functional stakeholders?

I could describe this process for hours as I think it is critical in the role and has to be properly set. To be crisp, I will explain 4 main actions:

First, I believe that meeting regularly with your teams (commercial, medical, legal… and all the other partners) to discuss projects and understand their goals, constraints, concerns is key.

Second, making sure to share the regulations guidelines, SOPS and Laws relevant to their projects and explain them in a way they are applicable to the business.

Third, taking time to train them so that they understand the policies and that those policies make sense for them.

Finally, taking grounded examples whenever you discuss contents, topics or situations that could pause risks or trigger challenges is necessary to move forward the process of approval.

To conclude, how would you maintain this effort in the long run?

First, more than being “just ” a regulations expert, act as a Business Partner with your cross-functional teams

Second, don’t hesitate to practice a lot, organise collaborative meetings, spend time on some background work, assess the different options

Third, don’t hesitate to prepare complex discussions upfront and spend the time needed to exchange

Fourth, don’t feel discourage if it does not come right away: this is a demanding and committing process that needs to be worked on with care and attention.

Caroline Petit is an International Advertising and Promotions Lead, Associate Director, Global Regulatory Affairs at Takeda, RAC EU/ US and CCB US Compliance Board certified.

Caroline has been trained in the field of EU& US Law and Regulations, Cognitive Neurosciences, Digital Transformation, Pharmaceutical Medicine, Business and Marketing, both in European and US Top-Tier Universities.

She has a significant experience in Global Advertising and Promotions, focusing on therapeutic areas such as Rare Disease and Neurosciences. Her passion and a strong commitment to help patients live a better life has driven her journey throughout pharmaceuticals.