Shire Associate Director, Nonclinical Regulatory Submissions in Cambridge, Massachusetts
The Associate Director of Nonclinical Regulatory Submissions leads authoring, timeline and reconciliation regulatory submission activities for nonclinical from project initiation through management approval. Responsible for the successful preparation of nonclinical components of regulatory submissions, including investigational applications, market applications, post approval variations, post approval reporting obligations, responses to regulatory queries, etc.
Works largely autonomously under general direction Incumbent collaborates effectively with relevant stakeholders, intra- and inter-departmental functional representatives in Regulatory, Clinical, Global Drug Safety, Global Regulatory Program Management, and program/project teams to ensure timely delivery of high quality, submission-ready documents that are consistent with relevant regulatory guidelines for global filings.
The Associate Director of Nonclinical Regulatory Submissions is additionally responsible for assisting in the tracking and compilation of all nonclinical documents for regulatory submissions. This individual will be highly analytical, decisive, goal- and customer service-oriented, and timeline sensitive while maintaining the highest of scientific and ethical standards.
The incumbant helps to develop and implement detailed plans and operating procedures for the compilation, QC, review, approval and hand-off to Regulatory Operations of all nonclinical and NCD-generated clinical documents for regulatory submissions. The incumbent will maintain established systems and procedures for maintaining quality standards for the format and content of nonclinical documents.
Responsibilities (% of time):
Manage/Lead preparation, writing, review of nonclinical components of regulatory submissions and all technical documents for a variety of projects of individual programs diverse in scope and complexity. Ensure timely delivery of high quality, submission-ready submission components that are consistent with relevant regulatory guidelines for global submissions (eg, US FDA, EMEA, PMDA, ICH).
Regularly liaises with Regulatory Affairs, Regulatory Operations, Program Management and NCD program-team representatives to maintain a current submissions schedule of assigned programs
Liaises efficiently and effectively with NCD functional leads and Regulatory Affairs/Operations to ensure clear submission aims, content requirements and timelines.
Independently manage external vendors and project scientists to deliver high quality submission documents that meet format and content requirements.
Work closely with NCD function leads (pharmacology, DMPK, bioanalysis, toxicology) to ensure appropriate input, review, approval and sign-off of documentation activities.
Coordinates cross-functional review of documents as required with other Shire functions and responses to QA audits relating to submissions.
Responsible for initial QC, formatting and line review prior to delivery of submission-ready nonclinical documentation/components to NRS Documentation Lead function.
Ability to rapidly assimilate/synthesize data and information from diverse sources, make judgments on complex/abstract problems and develop innovative solutions as necessary.
Ability to quickly and efficiently resolve planning conflicts, manage multiple projects simultaneously and deal with rapidly changing priorities.
Responsible for maintaining quality standards for the format and content of nonclinical documents.
Maintains awareness of changes in global Regulatory Authority nonclinical documentation requirements/expectations and ensures that Shire’s standards are compliant.
Develops and maintains processes to ensure that Shire standards for documentation, document transfer, version control and archiving are applied within NCD and by external vendors.
Collaborate effectively with relevant stakeholders to determine appropriate working areas, templates, styles and operational tasks for completion of each project.
Must have demonstrated ability in problem solving as applied to drug development and program/functional management.
Assist in development of strategies for nonclinical submissions with relevant program teams and NCD functional leads, and obtain line alignment and approval. Notify line management of significant deviations from plan.
Contribute to the development and maintenance of SOPs, templates, and style manuals.
Manage NCD components of Shire’s document management systems.
Liaises closely with Regulatory Operations and Shire/R&D IT to maintain EDMS as the central repository for reference and archiving of nonclinical submission documentation.
Represents NCD on R&D documentation initiatives as required.
Develops and maintains nonclinical documentation templates in EDMS.
Bachelors or Masters degree in Biochemistry/Toxicology or related subject.
At least 10 years experience working in nonclinical sciences within the pharmaceutical industry
At least 5 years experience compiling nonclinical documentation or regulatory submissions.
Fluency in written and spoken English is required.
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Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.