Results focused and detail oriented professional with experience working in a global pharmaceutical company, with multiple manufacturing sites and regulatory authorities worldwide. Analytical with strong background in understanding of FDA, ICH and other regulatory CMC requirements through all phases of development, post-approval, and life-cycle of the product. Proven ability to effectively manage time and multiple projects, contribute effectively to project teams, achieve deadlines and collaborate with colleagues on a global level.
Provide regulatory CMC support for all phases of the product development in the assigned portfolio and interface with Pharmaceutical Development, Project Management, Operations, Supply Chain, Quality, and Regulatory colleagues. Provide expert recommendations and decisions on regulatory issues relating to CMC, including proactive risk management and mitigation.
Develop effective regulatory CMC strategies for global submissions knowing the life cycle of drug product from development through commercialization and interpret and apply local regulations and guidance's to the life cycle of a drug product.
Oversee CMC documentation packages for regulatory submissions. Includes initial submission to Health Authorities, and preparation of responses to questions from Health Authorities.
Responsible for due diligence reviews for new development projects for new chemical entities or line extensions.
Responsible for development and maintenance of CMC data registration of INDs and NDAs and liaison with FDA.
Responsible for the development and coordination of the pre-commercial and post-commercial pharmaceutics activities associated with the development process.
Author/review/approve CMC-related IND amendments, NDA supplements and CMC sections of annual reports.
Support clinical supply strategies in conjunction with drug development initiatives
Responsibilities include the development and coordination of the pre-commercial pharmaceutics activities associated with the drug development process, including CMC data registration for investigational products and materials management activities in support of clinical trial support.
Work with drug development, analytical laboratories, licensers, manufacturers and packagers to develop clinical supply plans. Execute plans by coordinating manufacturing, packaging, labeling, and distribution.
Responsible for evaluating, selecting, and maintaining relationships with development and partners that manufacture, package and analyze clinical products.
Responsible for coordinating IND and NDA submissions and assisting in liaison to FDA.
Coordinate the scheduling, preparation of NDAs, INDs IND annual reports, safety reports, clinical protocols, pharmacology/toxicology, and CMC submissions. Review the contents of such documents prior to submission to FDA to ensure their completeness.
Responsibilities include coordinating activities related to clinical drug supplies between Clinical Research and Development and Pharmacy Development.
Provide packaging information for clinical protocols, design appropriate packaging and labels, and initiate timely delivery of clinical supplies to investigational sites.
Dispense and counsel patients on nonprescription and prescription medications. Perform managerial duties that include daily operations of a high volume store.
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