Roche
Healthcare
RegulatoryAffairsManager
“Regulatory Affairs Manager at Roche. Skills: Regulatory Affairs, USFDA regulations, Global submissions. Oversee regulatory document and submission compilation. Develop submission/product registration dossiers”
What You'll Achieve.
Accelerate world wide approvals
Industry & Context.
Navigate complex situations; Address problems or opportunities
Local to Indianapolis, Branchburg, Tucson, Santa Clara, Pleasanton, or Carlsbad
What They're Looking For.
Must Have
Bachelor’s / Master’s degree in Life Science, Data Science or related subject or equivalent experience, 3-5 years experience with PhD degree, 5-7 with Masters degree and 6-8 years with Bachelor degree in the field of IVDs/Medical devices/Pharmaiopharmaceutical with significant experiences in Regulatory Affairs or equivalent, Demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices, Knowledge of the European, US, China and other international regulations, Demonstrated ability to adequately interpret and implement quality standards, Demonstrated ability to manage more complex work and/or at parts of global projects
Nice to Have
Advanced degree, Experience with complex regulatory product launch strategies including advertisement and promotional reviews for Research Use Only (RUO) and IVD products pertaining to Sequencing technologies
What You'll Do.
Oversee regulatory document and submission compilation
Develop submission/product registration dossiers
Develop and manage global regulatory submissions
Support regulatory projects
Support overarching regulatory topics
Support systems and software including hardware-software instrument systems
Support Sequencing portfolio
Interface with external management
Lead organization to adapt to evolving regulatory environment
Interpret and apply understanding of regulators' thinking
Create unique/innovative regulatory strategies
Influence strategies and decision making
Partner with and influence stakeholders
Address problems or opportunities
Initiate activities independently
How You'll Work.
Team & Collaboration
Working closely with colleagues in other departments and other counties; Partner with and influence stakeholders; Involve collaborators for best solutions; Develop relationships that significantly influence direction; Pull people together around a common goal; Seek to understand and build on different perspectives; Address and resolve conflict; Bring out the best in people and teams
Communication Scope
Communicate timely and effectively the needs of external customers/stakeholders
Process & Methodology
Manage more complex work, Manage parts of global projects
Applying for this Regulatory Affairs Manager role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Roche?
Real rants from real employees. Read before you apply.