Shire Nonclinical Regulatory Submission Lead/Writer in Lexington, Massachusetts
Responsible for the successful preparation of nonclinical components of regulatory submissions, including investigational applications, market applications, post approval variations, post approval reporting obligations, responses to regulatory queries, etc. Also accountable for the successful preparation, review and publishing of technical documents for which the department is responsible, eg, nonclinical study reports, nonclinical & clinical bioanalytical reports and related nonclinical/clinical bioanalytical CSR or regulatory submission sections/content. Prepare and maintain related document templates, plans and timelines. Collaborate effectively with relevant stakeholders, intra- and inter-departmental functional representatives, eg, in Regulatory, Clinical, Program Management, and program/project teams to ensure timely delivery of high quality, submission-ready submission components that are consistent with relevant regulatory guidelines for global submissions.
- Manage preparation, writing, review of nonclinical components of regulatory submissions and all technical documents for which the department is responsible. Ensure timely delivery of high quality, submission-ready submission components that are consistent with relevant regulatory guidelines for global submissions (eg, US FDA, EMEA, PMDA, ICH).
- Collaborate effectively with relevant stakeholders, intra- and inter-departmental functional representatives and submission teams in coordinating development, review and hand-off of nonclinical sections of regulatory filings and clinical bioanalytical content to Regulatory Ops/Affair, Clinical Ops/Development/Medical Writing.
- Develop and maintain documents templates and high quality systems for tracking of nonclinical components of regulatory submissions, nonclinical technical and nonclinical & clinical bioanalytical reports and related nonclinical/clinical bioanalytical sections/content for global regulatory submissions.
College degree B.S./M.S. preferably in biology, pharmacology, toxicology, or related biomedical discipline. Minimum 4-6 years of experience in pharmaceutical or biotech product development with direct involvement in regulated studies related to pharmacology, toxicology, pharmacokinetics, etc.
Minimum 2 years experience in authoring nonclinical components of regulatory submissions.
Experience authoring nonclinical/clinical bioanalytical reports and related clinical documents preferred.
Equal Employment Opportunity
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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.