US-MA, Nonclinical Regulatory Submission Lead/Writer SR0040244-MZ
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.
Education and Experience Requirements
Key Skills, Abilities, and Competencies
Required Leadership Capabilities:
Complexity and Problem Solving
Internal and External Contacts
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, 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.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, 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.
Please visit our website at takedajobs.com