Julia Smith Email & Phone Number

Conshohocken, Pa, Us

Dublin, Ie

• Experienced in building and leading Global Regulatory Publishing team in mid-size pharmaceutical.• Design the vision for Global Regulatory Operations Publishing and represent the department with key stakeholders, regulatory affairs leadership team, and across the organization.• Execute the overall strategy for the team in accordance with corporate objectives.• Head team of up to 16 employees and contractors with oversight of individual employee development plans.• Oversee all regulatory submissions, ensuring adequate staffing, regulatory systems support, SOP adherence, and successful delivery of compliant global submissions.• Serve as regulatory contact to Health Authorities on technical aspects of filings.• Own business process and regulatory systems and technology supporting Publishing team. • Develop exemplary processes including authoring of SOP, Work Instruction, and Best Practice documentation.

Tokyo, Jp, Jp

• Leader in ViroPharma merger integration activities for GRA and the larger organization. • Integral to the delivery of harmonized business processes and regulatory technology solutions across products and sites. • Provides valuable technical and strategic expertise to regulatory submission contributors and stakeholders. • Independently manages submissions activities, planning and archiving regulatory records. • Ensures compliance in and delivery of high quality submissions to global health authorities in a timely fashion.

• Leader in the evolution from paper publishing to eCTD, and successful deployment of electronic publishing tools and development of the associated processes from inception.• Independent submissions management, content planning, tracking and publishing for initial filings and life-cycle submissions in major and emerging markets; including US, EU (National and Centralised Procedures), Canada, Australia, Switzerland (including para. 13), India, Japan and Israel.• Provides valuable technical and strategic expertise to submission contributors and stakeholders.• Direct communication with Health Authorities as it pertains to regulatory submissions.• Support budget allocation and rolling forecast coordination, review and entry for GRA.• Integral to ViroPharma/Shire merger and integration activities for GRA and the larger organization.

Brentford, Middlesex, Gb

• Successful submissions to US applications to CBER and CDER in various formats including paper, hybrid, and eCTD.• Established enthusiasm and ability to seamlessly transition across multiple roles throughout an extended GRO reorganization: from LifeCycle Management, to Pharma, then Biologics.• Demonstrated proficiency for all things electronic, by quickly adapting to an abundance of GSK applications to finalize submissions, such as Capri, CARDs, IMMS, Xpress, RAPID, etc.• Increased departmental efficiency by building more streamlined processes; for example, writing QC procedure or initiating training on underutilized tools.• International communication with document contributors as part of a complex matrix environment to ensure timely access to submission content.

• Earned project bonuses for under budget completion, promoted twice, multiple raises.• Successful prioritization and of a diversified responsibility set, including: staffing personnel, departmental submission planning, individual coordination of multiple applications, interviewing and recruitment, maintain daily client service relationship, client presentations, and cross-functional harmonization among submission contributors.• Formed valuable professional relationships through numerous on-site consulting contracts and gained understanding of industry best practices and standards. Clients include major and start-up Therapeutic, Biologic and Pharmaceutical throughout North America.