OVERVIEW
FOCUS AREAS
Experienced Senior Regulatory Affairs Professional assisting across the regulatory life sciences arena spanning from early development to post-licensing.
Emerging Markets
Regulatory Intelligence
Regulatory Strategies
Shaziya Saiyed is an experienced Senior Regulatory Affairs Manager with a diverse skill set across the regulatory field, committed to ensuring regulatory compliance and approvals for a diverse product portfolio. She is experienced with working in multidisciplinary teams from development (early, mid & late) to post licensing activities.
As a seasoned Senior Regulatory Affairs Manager, with over 8 years of experience, Shaziya has successfully navigated the complexities of global regulatory landscapes in the pharmaceutical and biotechnology sectors. Her expertise lies in developing and executing regulatory strategies that ensure compliance while expediting market access for innovative products. She has a proven track record of managing regulatory submissions, interactions with health authorities, and leading cross-functional teams through all phases of product development, from early research to product lifecycle management. Shaziya’s strategic insights and meticulous attention to detail have consistently delivered results that align with both business objectives and regulatory requirements.
Throughout her career, she has demonstrated exceptional leadership and problem-solving skills, particularly in guiding companies through the evolving regulatory environments of the EU, and emerging markets. Her ability to stay ahead of regulatory changes and anticipate potential challenges has been instrumental in securing timely approvals for a wide range of products, including pharmaceuticals and biologics. Shaziya is committed to fostering collaborative relationships with internal stakeholders and external partners, ensuring that all regulatory activities are conducted with the highest level of integrity and in compliance with global standard.
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EDUCATION:
Masters in Pharmacy, De Montfort UniversityASSOCIATION MEMBERSHIPS:
Member of General Pharmaceutical Council.
Member of TOPRA -
PROFESSIONAL EXPERIENCE:
Eliquent Life Sciences, 8 years
Preparation, review and delivery of regulatory submissions;
Reviewing Global Regulatory Strategy;
Lifecycle management;
Building CTD components for MAA’s;
Authoring clinical and nonclinical summaries and overviews;
Leader of CMC Gap Analysis matrix teams to translate strategy into deliverables as well as technical writing;
Knowledge of small and large molecule formulation and delivery systems;
Post licensing variations and renewals;
Emerging Markets and management of products for Rare Disease portfolios;
Coordination of MAAs across emerging markets as International Regulatory Lead;
Regulatory Intelligence Scanning;
Managing multiple projects
Community Pharmacist
McParlands Pharmacy, Pharmacy Manager, 4 years
ASDA Pharmacy, Pharmacy Manager, 9 year
Supervising and completing of pharmacy operational requirements;
Delivering patient-orientated clinical pharmacy services and pharmaceutical care;
Coordinating training and development goals through coaching;
Liaising regularly with relevant healthcare professionals to support patient care.
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