Leads nonclinical regulatory submission activities from project initiation through management approval. Collaborates effectively with relevant stakeholders, intra- and inter-departmental functional representatives in Regulatory, Clinical, Program Management, and program/project teams to ensure timely delivery of high quality, submission-ready documents that are consistent with relevant regulatory guidelines for global submissions.
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.
• Manage/Lead 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.
Education & Experience Requirements:
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.
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.
Equal Employment Opportunity
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
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.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.