Global Submission Manager
Sanofi
full-time
Posted on:
Location Type: Office
Location: Cambridge • Massachusetts, New Jersey • 🇺🇸 United States
Visit company websiteSalary
💰 $100,500 - $145,166 per year
Job Level
Mid-LevelSenior
Tech Stack
Assembly
About the role
- Applies project management skills and regulatory knowledge for global submission types, from standard to complex.
- Applies expert understanding on all dossier formats, standards, navigation and lifecycle management, eCTD, and ICH.
- Represents GRO Global Submissions Management on Global Regulatory Teams (GRTs) for assigned development and marketed products portfolio, per the GRA BluePrint model.
- Represents GRO Global Submissions Management on Submission Task Force (STF) meetings for major/complex submission filings and partner effectively with regulatory focal points on the Ops-specific details of lifecycle submissions.
- Leads discussions with stakeholders and submission task force teams involving electronic guidance issues to ensure an appropriate understanding of electronic submission requirements from a cross-functionally perspective, supporting successful submissions.
- Works within project teams in the control of submission component receipt and adherence to submission preparation completion.
- Directs the publishing activities for assigned portfolio to ensure high quality and timely submission delivery aligned to both Sanofi and Health Authority standards.
- Partners effectively with Submission Leads and global colleagues to deliver high quality and timely Global Simultaneous Submissions (GSS) filing plans, while also providing regional expertise.
- Acts as Subject Matter Expert (SME) in audits/inspections, special projects and issue resolution for regional activities.
- Partners with GRA and Digital functions as SME for current processes/data/technologies, as well as evaluating and implementing new/emerging technologies and requirements.
- May be assigned supervisory responsibilities.
Requirements
- Bachelor's degree, or advanced degree in regulatory affairs, the sciences, or related areas of study
- 5+ years of experience in the pharmaceutical industry, with direct regulatory affairs experience
- High degree of knowledge regarding the dossier assembly/production process and the structural organization, standards and requirements of regulatory dossiers
- Working knowledge of drug laws, regulations and guidelines
- Strong command of the English language, both spoken and written.
- Domestic and/or international travel (up to 10%)
Benefits
- High-quality healthcare
- Prevention and wellness programs
- At least 14 weeks’ gender-neutral parental leave
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
project managementregulatory knowledgedossier formatseCTDICHsubmission preparationpublishing activitiessubmission component controlauditsissue resolution
Soft skills
stakeholder engagementcross-functional collaborationcommunicationleadershipproblem-solving