Manager, Global Regulatory Affairs CMC Submissions Management応募後で応募 求人ID R0040306 掲載日 06/21/2021 Location:Boston, Massachusetts
Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Manager, Global Regulatory Affairs CMC Submissions Management in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager working on the Submissions Management team, you will be empowered to drive the Global CMC Submissions Team, and a typical day will include:
The Manager of GRA CMC Submission Management (CSM) R&D drives the Global CMC Submissions Team for Development submissions (IMPD/CTA/IND), Marketing Applications (NDA, MAA, BLA, JNDA) and Post-Approval Changes for where R&D deliverables are needed for commercial/GMS regulatory submissions the Research and Development (R&D) Division by managing a team of subject matter experts including Pharmaceutical Sciences representatives, Quality representatives, and cross-functional stakeholders in Regulatory. The manager establishes the document plan, negotiates timelines with authors, drives all deliverables against the timeline, compiles all submission ready documents, and delivers the final submission components to the Publishing team. Where R&D deliverables are needed for commercial/GMS regulatory submissions, the Manager collaborates with the CSM Lead in Global Manufacturing and Supply (GSM) to prioritize documents, drive the timeline and manage the R&D stakeholders. The Manager ensures all deliverables are prioritized and tracked and delivered on time, escalates issues where they are identified, and provides strategic insight on issue resolution.
- Maintain doc plan / timeline
- Develop TOC aligned with Reg-CMC strategy
- Collaborate with Reg-CMC and Content owners to prioritize and align deliverables
- Establish document structure
- Create vdoc and applicable templates
- Author management
- Drive meetings for kickoff, roundtables, content / data reconciliation, and follow-ups
- Lead RTQ process (e.g., Rapid Response Team)
- Maintain content verification / approval workflow
- Document management
- QC, formatting, uploading, filing history, headers / footers, linking, and folder / vdocstructure
- Document legalization, as needed
- Issue resolution and mitigation planning activities
- Manage submission readiness
- Content verification and the final quality check
- Prepare deliverables for support of submissions
- Transfer TOCs
- Provide submission ready docs to publishing
- Archive necessary documents
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Education and Experience Required:
- BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
- 4+ years pharmaceutical Regulatory CMC experience in a supportive role, or equivalent industry experience (e.g. Pharmaceutical Development, Analytical Development, Production, Quality Assurance).
- Familiarity with global regulatory guidelines and experience in regulatory submission (CMC Module 3 information and QOS documents) is essential
- Demonstrates attention to detail and problem-solving abilities.
- Exercises appropriate judgement when working with project teams.
- Exercises good judgement in elevating and communicating actual or potential issues to line management.
- Excellent written and oral communication skills required.
- Routine demands of an office based environment.
- Manual dexterity required to operate office equipment (ie computers, phones, etc)
- Ability to attend offsite meetings that may involve overnight stay
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.
Location and Salary Information:
- This job posting excludes CO applicants.
Effective November 1, 2021, absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. As of the same date, absent an approved religious or medical reason, US field-based employees, employees must be fully vaccinated in order to continue in their current roles. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. Candidates are encouraged to speak with their recruiter to seek further information on the applicable guidelines for the Business Unit/Function for which they have applied.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.