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    Welcome back to our ongoing series spotlighting Women in Leadership, launched by Business Manager Ethan Cortese who runs our Regulatory Affairs team.

    We are delighted to bring you our latest feature in our Women in Leadership series where we had the privilege of speaking with Tania Thomas, who is VP and Head of Global Regulatory and Medical Affairs at Opiant Pharmaceuticals.

    Tania’s career trajectory has been incredible, starting as a Pharmacist and immediately working in Regulatory Affairs as her first job. She has worked as an Assessor at the MHRA and went on to establish herself at Pfizer and GSK.

    I like to take risks and I’m not afraid of failure. You don’t learn if you don’t fail – and having a sense of curiosity and adventure is crucial. That mindset has allowed me to say yes to opportunities letting me experience Regulatory Affairs across a range of therapeutic areas, geographies and cultures, and in country versus Global roles.

    Writing is one of my passions and a key strength to have in Regulatory Affairs. Being able to write a solid justification and having good reading skills are invaluable, because if you don’t have a good grasp of what you need to demonstrate for a drug approval you are fighting an uphill battle. It goes without saying but good communication skills are also crucial for this job. 

    Networking is also key. Being able to integrate and build your own ‘community’ of people inside and outside of work can enable you to carve a successful career for yourself.

    I think that junior female reg professionals can become pigeonholed to certain roles, unless they have an advocate or a mentor who is looking out for them. What I mean by this is someone who can show them what other opportunities may be accessible to them out there. 

    Another common barrier is not advocating for yourself. Negotiation and standing up for yourself can feel extremely uncomfortable. Nobody enjoys doing it, but I think of it as a muscle – the more you practice it the easier it gets! You have to put yourself out there, not be afraid of rejection or of trying something new. Networking and getting yourself out of your comfort zone can be a huge help, especially as a female in an environment that may be male-dominated. 

    It’s also a manager’s responsibility to challenge people within their team (regardless of gender) and watch them improve over time. If you’re junior and you’re interviewing for a new role, empower yourself to choose a manager who is going to uplift you and enable you to progress – take responsibility and ownership of your own career!

    Definitely! I don’t see a lot of people leaving regulatory affairs because it’s such a great job, but I do see a lot of people from medical or public affairs coming into this job. 

    It also brings diversity of thought into the department as well as different skill sets. 

    For example, if someone knows about Clinical Development and they’re writing the Regulatory summaries, that’s going to look very different and be powerful in comparison to someone with a different skill set.

    During the pandemic, I stopped and took stock of where I was in my career, and thought to myself “where can my skills be of most value?”. When the opportunity came up to work on the opioid public health crisis facing USA today – being a healthcare professional I felt a professional responsibility to help, do something different and make a change. I guess you could say that the pandemic shifted my perspective massively, and I would never have known that I love what I do now had I not taken the risk.

    I would advise targeting a work/life harmony, which will enable you to offer your best self and true leadership in a role. Women do tend to get the brunt of responsibility within the home – and women in Regulatory have this idea that they have to be perfect at all times – especially in leadership! I have seen women take on responsibility for our entire gender – which becomes too much pressure and then they beat themselves up over it. 

    I would also advise women to “let it go” – and what I mean by that is don’t beat yourself up over a mistake. It’s part of our makeup as Regulatory professionals to be “perfect” at everything, but it’s counter-productive. Focus on providing value and don’t overcomplicate it if you do make a mistake. 

    Finally, have the confidence to be authentically you as a leader. Don’t take on other qualities just because everybody else is that way. When you do that, it takes away from your key qualities and how unique you are! For example, taking on masculine characteristics if all the other leaders are men. Leaders who are themselves are the most valuable, and if you’re forcing yourself to act differently from your authentic self I find that your stamina slows down and you become burnt out. 

    We do need more women in the leadership space, and we need more regulatory representation at C-Suite level, too. So, focus on adding value and showing up for yourself and others, listen effectively and don’t sacrifice your authenticity!

    I heard Jeff Bezos say once that you shouldn’t view it as a “balance”, but rather as a harmony, and that’s how I intentionally choose to live my life. I believe that there’s a way to live your life holistically and harmoniously, where work is a huge part of it but also your home life is too. 

    I’ve found harmony within my life with a very supportive partner, and that’s how I’ve been an effective leader and provided true leadership. When I’m at work I’m focused on work and when I’m at home I’m focused on being at home. It’s about being present as a leader in that exact moment. 

    How does that translate to a work situation? When you’re in a meeting don’t think about what you’re supposed to be saying or thinking, “I haven’t spoken for 20 minutes” – just be there in the moment and provide value when it’s needed.

    The most memorable is the most recent – which is the approval that I led for a small Biotech company. I led a collaborative, high-functioning team driven by an aligned mission, to achieve getting a product approved to help a public health crisis. We met every regulatory milestone that we set!

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