Regulatory Assurance Specialist
CDM Smith
Director, Global Regulatory Affairs – Global Labeling Strategy
Sanofi
full-time
Posted on:
Location Type: Office
Location: Morristown • Massachusetts, New Jersey • 🇺🇸 United States
Visit company websiteSalary
💰 $172,500 - $249,167 per year
Job Level
Lead
About the role
- Lead the development, maintenance, and alignment of global labeling strategy and content (e.g., CCDS, USPI, SmPC) for assigned products throughout the product lifecycle
- Provide regulatory labeling leadership to cross-functional teams (Regulatory Strategy, Clinical Development, Medical Affairs, Pharmacovigilance, Market Access…)
- Contribute to early development programs by identifying labeling-relevant clinical endpoints, offering strategic input into the design of Phase 2 and Phase 3 clinical trials
- Assess opportunities for the integration of patient experience data (e.g., PROs, QoL measures) to support future labeling claims
- Represent Global Labeling on global regulatory teams and labeling sub-teams; lead labeling-related discussions and decision-making
- Coordinate end-to-end labeling processes, including governance review, internal alignment, and submission planning for regulatory dossiers
- Support regulatory agency interactions and negotiations involving labeling content; contribute to strategy for responding to health authority questions or label revisions
- Ensure consistency between core and local market labeling; collaborate with regional /country regulatory teams to address labeling implementation or compliance issues
- Monitor external regulatory environment, competitor labeling trends, and emerging guidance to inform strategic labeling decisions, and partner with GRA policy teams to connect the evolution in the environment with the labelling strategy
- May lead or participate in process improvement, digital transformation, or operational excellence initiatives within Global Labeling and transversally across GRA/Sanofi as applicable
- Mentor and guide junior team members; may directly supervise Global Labeling Strategists depending on organizational structure
Requirements
- Earned Bachelor’s degree in life sciences, pharmacy, or medically related field required
- Advanced degree (PharmD, PhD, MD or MSc) preferred
- Minimum 10 years of experience in the pharmaceutical or biotechnology industry, including 5+ years in regulatory affairs with significant experience in labeling strategy
- Experience with investigational and marketed products across multiple regions (US, EU required)
- Proven involvement in early development labeling strategy, including contributions to clinical protocol development and endpoint discussions
- Experience incorporating patient-focused evidence into labeling strategy is a plus
- Prior experience managing or mentoring team members is preferred
- Strong knowledge of global regulatory labeling requirements (FDA, EMA, ICH) and lifecycle labeling best practices
- Strategic thinking with the ability to anticipate and influence regulatory direction across the development continuum
- Scientific rigor and analytical ability to interpret complex data and develop regulatory-sound labeling content
- Proven leadership and collaboration skills in cross-functional, matrixed environments
- Excellent communication, negotiation, and stakeholder management skills
- Project and time management expertise; able to manage multiple priorities in parallel
- Strong understanding of regulatory submission processes and health authority interactions
Benefits
- Exposure to cutting-edge technologies and research methodologies
- Networking opportunities within Sanofi and the broader biotech community
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory affairslabeling strategyclinical protocol developmentpatient-focused evidenceregulatory submission processesFDA regulationsEMA regulationsICH guidelineslifecycle labeling best practicesanalytical ability
Soft skills
strategic thinkingleadershipcollaborationcommunicationnegotiationstakeholder managementproject managementtime managementmentoringsupervision
Certifications
Bachelor’s degree in life sciencesPharmDPhDMDMSc