Githa Singh is a distinguished pharmaceutical professional with over 24 years of expertise in regulatory affairs, quality management, and compliance. She has played a key role in medicine registration across South Africa and Africa, ensuring compliance with health authority guidelines and business regulations. Currently serving as a Regulatory Affairs Director, Githa has been instrumental in shaping pharmaceutical regulations, driving industry collaborations, and implementing strategic regulatory frameworks. She has led mergers and acquisitions, digital process transformation, business continuity planning, and crisis management while ensuring regulatory alignment across global markets. Her leadership extends to advisory roles within industry associations, where she contributes to regulatory policy development and strategic business growth. Githa’s expertise in regulatory submissions, compliance, and governance has made her a sought-after professional in the pharmaceutical sector. Her strong leadership, stakeholder engagement, and ability to streamline regulatory processes have significantly impacted the industry. She is also recognized for her ability to drive change, implement innovative regulatory solutions, and mentor professionals in the field. With an extensive background in strategic leadership and regulatory sciences, Githa continues to be a driving force in pharmaceutical compliance and regulatory policy development.

Professional Profile

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Education

Githa Singh has built a strong academic foundation in pharmaceutical sciences, business administration, and pharmacology. She earned her Bachelor of Pharmacy (B.Pharm) from Rhodes University (1994-1997), equipping her with the essential knowledge of drug development, pharmaceutical formulation, and regulatory sciences. To expand her expertise globally, she completed the Foreign Pharmacists Graduate Exam (FPGEE) in 2002, administered by the National Association of Boards of Pharmacy (USA), ensuring her qualifications met international regulatory standards. Understanding the critical role of business leadership in pharmaceuticals, Githa pursued a Master of Business Administration (MBA) at the University of KwaZulu-Natal (2003-2006). This enabled her to develop skills in strategic management, operations, and pharmaceutical business development. Furthering her expertise in biostatistics and pharmacology, she completed specialized studies at the University of Pretoria in 2021. Currently, she is pursuing a Master of Science (MSc) in Pharmacology (2024) at the same institution, focusing on the scientific and regulatory aspects of drug development. Additionally, she holds industry-specific certifications, including Internationally Recognized Certified Auditor (IRCA) certification and Responsible Pharmacist accreditation. Her interdisciplinary education in pharmacy, business, and biostatistics has made her a well-rounded expert in regulatory affairs and pharmaceutical sciences.

Professional Experience

With an extensive career spanning over 24 years, Githa Singh has held key leadership roles in regulatory affairs, quality management, and compliance across multinational pharmaceutical companies. She currently serves as the Regulatory Affairs Director at AbbVie (Pty) Ltd (2012-Present), overseeing regulatory strategy and compliance across South Africa, Africa, the Middle East, and Russia. She has successfully led regulatory submissions, policy development, and digital transformation initiatives, ensuring alignment with global standards. Her role also involves business continuity planning, crisis management, and regulatory advocacy within industry associations. Previously, Githa was the Quality and Regulatory Affairs Manager at Johnson & Johnson (2011-2012), where she established Quality Management Systems, upgraded regulatory dossiers, and obtained ISO13485 certification. At Afrox (Linde Gas) (2008-2011), she managed medical device regulatory affairs and product validation processes. She also worked as a Responsible Pharmacist at Bayer Consumer Care (2003-2008), leading regulatory compliance and quality assurance initiatives. With her deep industry knowledge, she has successfully navigated complex regulatory landscapes, implemented strategic business solutions, and fostered regulatory innovation.

Research Interest

Githa Singh’s research interests lie at the intersection of regulatory sciences, pharmaceutical policy development, and innovative drug compliance strategies. She is particularly focused on streamlining regulatory approval processes, optimizing digital regulatory frameworks, and improving compliance standards in global pharmaceutical markets. Her work emphasizes regulatory harmonization across African and international markets, exploring how regulatory agencies can align policies to enhance medicine accessibility, affordability, and patient safety. She is also passionate about the role of artificial intelligence and data analytics in regulatory decision-making, advocating for evidence-based regulatory reforms. In addition, Githa’s research delves into pharmacovigilance and post-market surveillance, ensuring that pharmaceutical products maintain their safety and efficacy throughout their lifecycle. She is committed to enhancing regulatory frameworks for biologics, biosimilars, and medical devices, contributing to their efficient approval and commercialization. Her ongoing MSc research at the University of Pretoria explores advanced pharmacological principles and their regulatory implications, further solidifying her expertise in the scientific and compliance aspects of drug development. Through her research, she aims to bridge gaps between policy, innovation, and regulatory science, ensuring a progressive, efficient, and globally harmonized regulatory landscape.

Research Skills

Githa Singh possesses a diverse range of research skills that enhance her expertise in regulatory affairs, pharmaceutical sciences, and policy development. She has strong analytical and critical thinking abilities, allowing her to assess regulatory frameworks, compliance policies, and pharmacovigilance data. Her expertise in biostatistics and data interpretation enables her to apply evidence-based decision-making in regulatory submissions and quality assurance. Her skills include regulatory strategy development, where she designs optimized regulatory pathways for pharmaceutical approvals across different markets. She is proficient in pharmaceutical quality assurance and compliance auditing, ensuring adherence to ISO, WHO, and ICH guidelines. Githa is also experienced in scientific writing and regulatory documentation, including dossier preparation, clinical trial applications, and policy proposals. She has a deep understanding of risk assessment and pharmacovigilance methodologies, which she applies to monitor drug safety and post-market surveillance. Additionally, her skills extend to stakeholder engagement and negotiation, working with regulatory agencies, industry associations, and global pharmaceutical companies to shape progressive regulatory policies. Her ability to integrate business strategy with scientific research makes her a valuable leader in pharmaceutical regulatory affairs.

Awards and Honors

Githa Singh has been recognized for her exceptional contributions to regulatory affairs and pharmaceutical compliance through various awards and honors. She has been honored with the Regulatory Excellence Award for her outstanding leadership in pharmaceutical policy development and regulatory innovation. Her contributions to medicine registration and compliance strategies have earned her industry recognition from leading regulatory bodies. As a key member of industry associations, she has received accolades for her advocacy in regulatory policy reforms. Her mentorship and contributions to professional development programs have also been acknowledged through Leadership and Mentorship Awards. Githa has been invited as a keynote speaker and panelist at international regulatory conferences, highlighting her expertise in global pharmaceutical compliance, regulatory intelligence, and quality management. Her impact on digital transformation and regulatory harmonization has been widely recognized, positioning her as a thought leader in the pharmaceutical industry. Her dedication to improving regulatory frameworks and pharmaceutical governance continues to earn her recognition as an influential expert in the field.

Conclusion

Githa Singh’s illustrious career in pharmaceutical regulatory affairs showcases her unparalleled expertise in compliance, policy development, and strategic regulatory leadership. Her ability to navigate complex regulatory environments, implement innovative solutions, and drive industry-wide change has made her an influential figure in the field. Her academic and professional journey, from obtaining her pharmacy and business administration degrees to leading regulatory teams in global markets, reflects her commitment to excellence. Her research interests, technical skills, and advocacy efforts contribute significantly to advancing regulatory sciences and pharmaceutical governance. Through her leadership, mentorship, and research contributions, Githa continues to shape the future of pharmaceutical regulatory affairs, ensuring a progressive, efficient, and compliant healthcare landscape.

Publications Top Notes

1. Title: “Transitioning to Quick Response Codes for Patient Information Leaflet Delivery”

   • Authors: Githa Singh, Sarel J. Brand, Vanessa Steenkamp

   • Journal: Exploratory Research in Clinical and Social Pharmacy

   • Volume: 17

   • Article Number: 100563

   • Year: 2025

   • DOI: 10.1016/j.rcsop.2025.100563

   • PubMed ID: 39896174

   • PMC ID: PMC11786840

2. Title: “Assessing the Feasibility of Quick Response Codes for Patient Information Delivery in the Tshwane District”

   • Author: Githa Singh

   • Source: PQDT-Global

   • Year: 2023