Shire Regulatory Technology & IM Manager in Cambridge, Massachusetts
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.
% of Time Job Function and Description
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.
Education and Experience Requirements
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:
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.
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.
Key Skills, Abilities, and Competencies
International experience is strongly desired.
Excellent verbal and written communication skills; ability to communicate effectively to multiple levels in the organization with strong negotiation skills.
Excellent analytical and communication skills both verbal and written.
A self-starter who motivates, has tact, diplomacy, leadership skills and who has a flexible and positive approach.
Ability to work on complex projects and timelines in a matrix team environment.
Strong attention to detail and accuracy is a must.
Demonstrated ability to integrate planning efforts across departments to ensure organizational effectiveness.
Ability to cultivate internal and external relationships based on trust and respect in anticipation of future working relationships; demonstrated ability to proactively maximize relationships to enable successful collaboration; demonstrated ability to facilitate a beneficial resolution of conflict.
Ability to articulate a clear vision and help others understand their relationship between their roles, the roles of others and the overall goals of Shire; ability to articulate the reason behind organizational changes and demonstrate flexibility, energy and resilience throughout change efforts.
Demonstrated ability to work cooperatively within and outside the organization to accomplish the best outcomes for Shire; ability to work in diverse teams to optimize decision-making.
Demonstrated ability to provide coaching and feedback to foster professional development while also supporting business goals.
Must have the ability to understand and reduce to practice Global Regulatory regulations and guidelines, i.e. FDA and EU regulations, and ICH guidelines.
Must have experience with industrial interpretation with respect to regulatory expectations.
Familiarity with the drug development process.
Working knowledge of business software, including: MS Word, Excel, PowerPoint, Project, Adobe Acrobat and Outlook.
Strong interpersonal, managerial and organizational skills.
Strong technical and problem solving skills, with an ability to understand and translate business issues and requirements.
Knowledge of process development methodologies
Complexity and Problem Solving
Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Ensures budgets, schedules and performance requirements are met.
Other Job Requirements
Domestic and international travel may be required for this position.
Approximately 10% travel may be required
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
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.
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.