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Areas of expertise
A seasoned executive leader, Maria Perrotta bring over 20 years of experience in global regulatory affairs, quality assurance, compliance, regulatory policy, and clinical research within multinational biopharmaceutical companies. She holds expertise in driving regulatory strategies, with a proven track record of leading cross-functional teams to navigate complex regulatory environments and influence policy to accelerate drug development and new drug approvals. During her career in regulatory affairs, her focus has been to advocate for the approval of safe and effective therapies that address unmet medical needs and enhance quality of life. She has secured timely market authorizations for new drugs and new uses of medications. Throughout her career, Maria also established success in managing regulatory filings, optimizing product labeling, and ensuring compliance across North America, Europe, and global markets (in liaison with FDA, EMA, Health Canada, and MHRA). She has developed trusted relationships with thought leaders in the field, scientific and medical experts, patient associations, Health Canada and Industry Associations; and contributed to government initiatives aimed at the transformation of the Canadian federal regulatory and policy framework for drugs and medical devices.
Skilled in coaching individuals and teams to deliver high-quality results, and a visionary leader, Maria is committed to fostering collaborative environments, driving continuous improvement, and improving health and wellness outcomes.
Maria Perrotta is based in the Montreal Area (St. Bruno), Quebec, Canada.
Maria thrives on innovative thinking and enjoys guiding people on their journey of personal and professional self-discovery and mastery. She is passionate about continuous learning and personal development; and values being part of a greater purpose and making a positive global impact. As an Associate Certified Coach and lifelong learner, Maria is committed to inspiring, empowering, and supporting individuals and teams to achieve their full potential, reach their personal and career goals, and to deliver outstanding results that surpass their expectations. Maria leverages her business acumen, pharma industry expertise, effective listening and communication skills to provide consulting and coaching services that foster a culture of continuous learning, transformative growth and innovation. Her mission is to make a beneficial impact on people's lives through her vocation and leadership.
Maria has helped me distill my goals into achievable and meaningful action items; there were goals that I have been struggling to accomplish on my own for years, and Maria really helped direct and focus my energy into achieving them I have used Maria’s coaching to navigate challenges through several positions. Maria was also instrumental in helping me transition into becoming an effective working parent and helping me understand that it is possible to prioritize family and move forward with career goals at the same time. This was especially critical to me during the pandemic. More recently, Maria has helped me transition successfully into a new type of role. Maria is very attentive and takes the time to listen and understand my end goals. I also very much appreciate Maria’s mentoring as she has years of experience in various leadership roles.
G. K.
With Maria's assistance, I was able to gain clarity with respect to my approach and my priorities. We had conversations every couple of weeks through video conference. Despite not being able to meet in person due to the pandemic, Maria proved to be a focused and attentive listener. She was able to guide my reflection by asking questions that helped me sort out my thoughts or challenge my concerns. She did so with tact, empathy and patience. My experience with Maria gave me the confidence to step into my new role with purpose and conviction. She helped me recognise and leverage the skills I bring to the table, while finding constructive ways to continue learning and improving. Perhaps most importantly, she gave me the tools I needed to navigate periods of uncertainty without becoming too overwhelmed. I am grateful to her for playing such a pivotal role in my success during the last year.
N. K.
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