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Regulatory Technologies & IM Manager

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POST DATE 9/7/2016
END DATE 12/10/2016

Shire Pharmaceutical Lexington, MA

Lexington, MA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)
Bachelors Degree


Job Description
The Global Regulatory Technology and IM Manager will further the vision for Global Regulatory Affairs (GRA) in alignment with Shire s business model to establish and support Shire s global approach for regulatory technologies and regulatory information management. This position will provide global support to the Regulatory Affairs and Regulatory Operations organizations for GRA system and collaborate with the respective R&D Information Technology staff.

Drives the development and update of GRA processes and standards:
Provides Business SME support to GRA in the use of GRA systems, and development and maintenance of supporting information related to the use of GRA systems, e.g. system job aid/ help guide.
Establishes, updates and implements Regulatory-required formats, templates, policies, standards, and procedures for regulatory submissions.
Provides Business SME support for tools that manage R&D Submissions and Registrations.
In partnership with R&D IT, ensures that GRA requirements are incorporated and supported by both new systems and also upgraded to existing systems.

Manages Regulatory information systems in support of GRA through Business User support in partnership with R&D IT.
Provides recommendations in formulating new technology and guidance.
Provides Business User support and recommendations on the structure and preparation of electronic regulatory submissions.
Provides Business User support and recommendations on regulatory specifications for submissions, and the ability of publishing tools and systems to support them.
Maintains up-to-date knowledge of global standards and procedures for regulatory submissions, including eCTD, IDMP; Publishing standards and analyzes new and revised guidance, advises regulatory management of new requirements, and recommends course of action.
Provides recommendations on the approach for the application of expert knowledge of global regulatory requirements for systems or policies with all contributing functions that ensure submission compliance.

Bachelor's degree or related experience is required. Scientific and/or computer science field preferred.
Minimum of 6+ years of pharmaceutical experience in a R&D environment or (9+ years without a Bachelor degree), of which:
o Minimum of 3+ years experience in a technical support and information management, preferably within an R&D environment or 6+ years without a Bachelor degree.
o Minimum of 3 years of experience in electronic document management (or 5+ years without a Bachelor degree).

Knowledge of the requirements for electronic submissions to regulatory authorities. Experience in the preparation and submission of documents using regulatory/document management systems (e.g. Documentum , FirstDocs ,eCTDXpress, Validation tools) is highly preferred.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.

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.

Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law
EEO is the Law - Supplement
Pay Transparency Policy

Reasonable Accommodations
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Minimum Requirements