Shire Regulatory Submission Manager in Cambridge, Massachusetts

The Submissions Manager is accountable for managing the major/complex submission activity for Shire’s portfolio. The Submissions Manager designs and executes high quality global submission plans, ensuring Shire delivers compliant submissions to global health authorities within required timeframes. They must provide technical expertise to partnering business lines to drive excellence in the design, implementation and delivery of regulatory submissions. The Submissions Manager is the primary point of contact for project and/or submission teams when significant planning effort and oversight is required.

Responsibilities

65%

  • Work independently with project teams to design and execute high quality submission plans, ensuring the timelines and requirements are mutually understood and in line with Shire and health authority standards.

  • Ensure GRO delivers high quality, compliant submissions to global health authorities within required timeframes.

  • Work with GRO submission teams to effectively forecast and manage project specific resources, utilizing flexible resourcing and global load sharing in a matrix environment.

  • Maintain a fluency in use of electronic and paper publishing systems and tools and global submission formats, with hands on publishing when required.

  • Define and implement regional and global processes for paper and electronic submission publishing, including the evaluation of current processes.

  • Interpret regulatory guidelines to produce regulatory submission business requirements and ensure that those requirements are implemented where appropriate at local level.

  • Adhere to the appropriate use of technical tools, through use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved.

  • Operate as Subject Matter Expert in dossier types, processes and/or technical solutions, with responsibility for training and mentoring fellow colleagues.

  • Responsible for the review of R&D documents to ensure compliance with Shire’s submission ready standards guidelines.

25%

  • Lead and contribute to new and updated process and standards.

  • Participates in validation testing and requirements gathering of new and upgraded software.

  • Responsible for the accuracy of information for submission metrics and registration information for senior management.

  • Lead and/or participate in GRA special initiatives.

10%

  • Management of vendor resources, when applicable.

  • Delegation of tasks in a matrix environment, providing feedback to staff and their line management.

Education & Experience Requirements

  • Bachelor's degree or equivalent work experience is required. Scientific and/or computer science field preferred.

  • Minimum 5 years of pharmaceutical experience in a global regulatory environment, including experience with document management technology and electronic publishing software (e.g. Documentum, FirstDocs, ISI Toolbox, eCTDXpress, etc.).

  • 5+ years of project management experience.

Other Job Requirements

  • Domestic and international travel may be required for this position.

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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Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

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.

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.