Global Labeling Strategist
Sanofi
12 hours ago
Remote friendly (Morristown, NJ)
United States
$148,500 - $214,500 USD yearly
Corporate Functions
Main Responsibilities:
- Lead or co-lead the preparation, review, and maintenance of global labeling strategy and content (CCDS, USPI, SmPC) for assigned products throughout their lifecycle.
- Collaborate with clinical, medical, safety, and regulatory teams to provide labeling input for clinical study protocols (early and late development).
- Contribute to clinical endpoint selection discussions and integrate patient experience data to maximize labeling value.
- Assist with labeling submissions, regulatory queries, and updates to ensure compliance with regulatory expectations and company standards.
- Support alignment between core global labeling and regional/local labeling requirements.
- Participate in cross-functional regulatory teams and labeling governance processes.
- Stay informed of relevant regulatory guidelines, industry trends, and competitor labeling activities.
- Mentor/training for more junior labeling strategists and support labeling process improvements.
Competencies/Skills:
- Knowledge of global regulatory labeling requirements (US, EU).
- Ability to interpret clinical data/protocols for regulatory labeling implications.
- Strong cross-functional communication and stakeholder management.
- Attention to detail/organizational skills; manage multiple deliverables.
- Proactive, able to work independently and with supervision.
Experience/Qualifications:
- Bachelor’s degree in life sciences, pharmacy, or medically related field required; PharmD/PhD/MD/MSc preferred.
- 8+ years pharmaceutical industry experience, with at least 4 years in regulatory affairs or labeling.
- Experience supporting labeling strategy for developmental and/or marketed products.
- Familiarity with clinical protocol development and regulatory labeling expectations.
- Exposure to patient experience data and regulatory relevance (advantageous).
Benefits (as stated):
- At least 14 weeks’ gender-neutral parental leave; health and wellbeing benefits including high-quality healthcare and prevention/wellness programs.
- Lead or co-lead the preparation, review, and maintenance of global labeling strategy and content (CCDS, USPI, SmPC) for assigned products throughout their lifecycle.
- Collaborate with clinical, medical, safety, and regulatory teams to provide labeling input for clinical study protocols (early and late development).
- Contribute to clinical endpoint selection discussions and integrate patient experience data to maximize labeling value.
- Assist with labeling submissions, regulatory queries, and updates to ensure compliance with regulatory expectations and company standards.
- Support alignment between core global labeling and regional/local labeling requirements.
- Participate in cross-functional regulatory teams and labeling governance processes.
- Stay informed of relevant regulatory guidelines, industry trends, and competitor labeling activities.
- Mentor/training for more junior labeling strategists and support labeling process improvements.
Competencies/Skills:
- Knowledge of global regulatory labeling requirements (US, EU).
- Ability to interpret clinical data/protocols for regulatory labeling implications.
- Strong cross-functional communication and stakeholder management.
- Attention to detail/organizational skills; manage multiple deliverables.
- Proactive, able to work independently and with supervision.
Experience/Qualifications:
- Bachelor’s degree in life sciences, pharmacy, or medically related field required; PharmD/PhD/MD/MSc preferred.
- 8+ years pharmaceutical industry experience, with at least 4 years in regulatory affairs or labeling.
- Experience supporting labeling strategy for developmental and/or marketed products.
- Familiarity with clinical protocol development and regulatory labeling expectations.
- Exposure to patient experience data and regulatory relevance (advantageous).
Benefits (as stated):
- At least 14 weeks’ gender-neutral parental leave; health and wellbeing benefits including high-quality healthcare and prevention/wellness programs.