Regulatory Process and Standards Manager - Lexington, MA



July 31, 2014

Primary Role:
The Process & Standards Manager is responsible for designing and implementing high quality processes and standards and for ensuring internal compliance for Global Regulatory Affairs (GRA). This role collaborates with all functions within GRA to design optimum regulatory standards and interfaces between GRA and other functions within R&D. The Process & Standards Manager also contributes to and/or project manages GRA special initiatives.

Lead and contribute to development and update of GRA processes and standards:
* Collaborate with GRA professionals and Shire R&D functions to develop, maintain, update and implement global operational processes/standards as needed.
* Alert GRA leadership of significant deficiencies in processes/standards and compliance and recommends corrective action plans.
* Participate in GRA internal/external audits and collaborate with GRA to review and implement corrective action plans in relation to noncompliance.
* Support the optimization of processes/standards to support GRA's strategies globally and ensuring that these standards meet with regulatory agency requirements and Shire's agreed standards.
* Review GRA processes/standards to identify opportunities for improvement and consistency with regulatory agency requirements.
* Examine interfaces between GRA processes/standards versus those of other functions within R&D to identify opportunities to improve the overall efficiency of Regulatory at Shire.

Lead and contribute to GRA 'special projects' for the continuous improvement of GRA:
* Participate in and/or provide project management support for GRA special initiatives, including the development of project scope, metrics, success measures and reporting of overall outcome.
* Create and deliver presentations that support the Process, Standards and Training group.
* Lead or contribute to GRA continuous improvement efforts.
* Management of vendor resources, when applicable.
* Delegation of tasks in a matrix environment, providing feedback to staff and their line management.

Education and Experience Requirements:
* Bachelor's degree in scientific field is required.
* 5-8 years of pharmaceutical experience in an R&D environment.
* Generally has at least 1 year of management level experience in R&D.
* Experience in compliance related environment strongly preferred.
* Standard consulting experience strongly preferred.

Other Requirements:
* Domestic and international travel may be required for this position.
* Approximately 5% 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 livesAs 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.

Please apply at: Application URL:


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