The Head of Nonclinical Regulatory Submissions is responsible and accountable for the planning, tracking, compilation and delivery of all nonclinical documents for regulatory submissions. The successful group leader is expected to maintain a flat, consensus-driven team and to balance big picture, long-term and strategic considerations with tactical, detailed technical aspects in approaching and dealing with project/program or product-related regulatory submission issues. 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 Head of Nonclinical Regulatory Submissions develops and implements detailed strategic plans for the compilation, QC, review, approval and hand-off to Regulatory of all nonclinical and NCD-generated clinical documents for regulatory submissions. The incumbent will establish and maintain high quality systems and procedures for maintaining quality standards for the format and content of nonclinical documents and is responsible for ensuring final formatting and delivery of nonclinical documentation/components to Shire's submission-ready standard.
Leadership and oversight of the nonclinical DMPK group.
Lead the planning, tracking and compilation of all nonclinical documents for regulatory submissions:
* Regularly liaises with Regulatory Affairs, Regulatory Operations, Program Management and NCD program-team representatives to maintain a current submissions schedule and understanding of nonclinical documentation needs.
* Evaluates the capabilities and competencies of documentation vendors and consultants; is responsible for establishing preferred provider arrangements and for securing appropriately skilled resources for documentation activities.
* Liaises efficiently and effectively with NCD functional leads and Regulatory Affairs/Operations to establish clear submission aims, content requirements and timelines.
* Works closely with vendors and project scientists to deliver high quality submission documents that meet format and content requirements.
* Works 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.
* Is responsible for final formatting and delivery of nonclinical components to Shire's submission-ready standard.
* Is responsible for planning and coordinating the QC checking of nonclinical documents and for coordinating responses to QA audits relating to submissions.
Responsible for developing and maintaining quality standards for the format and content of nonclinical documents.
* Works closely with NCD functional leads and Regulatory Operations to define/develop Shire standards for the format and content of nonclinical study reports and submission 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.
Responsible for NCD components of Shire's document management systems.
* Liaises closely with Regulatory Operations and Shire/R&D IT to develop and maintain 3D as the central repository for reference and archiving of nonclinical submission documentation.
* Represents NCD on Shire-wide and R&D documentation initiatives.
* Develops and maintains nonclinical documentation templates in 3D
Education and Experience Requirements:
* 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.
Domestic and international travel may be required
Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives As an Equal Opportunity and Affirmative Action Employer, Shire is committed to a diverse workforce. US Applicants who require accommodation in the job application process may contact 484-595-8400.