Leadership team
Merav is an experienced regulatory affair professional with over 25 years working within pharma and consultancy companies. Merav has a pharmacy background and she leads the global regulatory affairs team at Clinigen overseeing delivery of global projects and development and growth of the team.
Sarah joined Clinigen in 2016 and provides pharmacovigilance oversight across the Clinigen Group, both for the products for which Clinigen is the Marketing Authorisation Holder, as well as for PV Services provided to Clients for early access programmes. Prior to this she spent 17 years in multi-aspect Pharmacovigilance roles, starting her career at the MHRA, then working in a number of global positions for both small-medium and large Pharmaceutical companies.
Andy joined Clinigen in 2019 and has over 25 years of experience in medical affairs roles within the pharmaceutical industry. Andy oversees the delivery of high-quality medical information (MI) services for Clinigen’s portfolio of products together with MI services provided to Clients for managed access programmes. As a UK registered pharmacist, Andy is also a UK Medical Signatory, for the review and approval of promotional and non-promotional materials, contracts, and proposals to ensure compliance with the ABPI Code of Practice and other relevant regulations and guidelines.
Pharmaceutical professional with nearly 10 years of experience in Pharmacovigilance. Joined Clinigen in 2019 and been responsible for leading SERM activities and providing SERM expertise globally for Clinigen as a MAH and as a service provider. Currently acting as Deputy UK QPPV and provide support to UK QPPV and manage and support the QPPV office. In addition, acting as a responsible person for clients for DSN, a Clinigen company.
With a background in medicinal chemistry(PhD), Melanie has over 15 years’ experience in regulatory affairs within pharma and consultancy. Melanie specializes in regulatory strategy and execution in product acquisition, authorisation and licence optimisation.
With over 15 years of experience in quality control, research development and regulatory affairs, Vamshee has been Clinigen’s Regulatory Affairs Director since 2017. He guides product development through European and international regulatory processes and specialises in development strategies, including preparation, planning, and participation in scientific advice meetings with regulatory agencies. Vamshee also offers insights on in-licensing opportunities and acquisitions, leveraging his background as a trained pharmacist.
Elizabeth has extensive understanding of the complex environment of unlicensed medicines and early access, having worked in this field for over 10 years. Elizabeth advises pharmaceutical and biotech companies on regulatory strategies and compliance throughout Managed Access Programmes to enable best outcomes in product development and patient access.
Michelle joined Clinigen in 2018 and works with internal and external stakeholders on the development of regulatory strategy for compliant access programs. Additionally, she has regulatory responsibility for a licensed product within Clinigen. Prior to joining Clinigen, she held a variety of roles across Pharmacovigilance, Auditing, Health Economics and Regulatory Affairs. Michelle has a BSc degree from Stellenbosch University, South Africa.
Natalie McGregor joined Clinigen in 2019 and is currently Senior Regulatory Affairs Manager for Clinigen's products, and works with internal and external stakeholders on the development of regulatory strategy for compliant Managed Access Programs. Prior to joining Clinigen she held a variety of Regulatory Affairs roles in the pharmaceutical and biotech industries including in clinical and medical device trials. Natalie has a PhD in Biochemistry.