Global Labeling Strategist
Sanofi
11 hours ago
Remote friendly (Cambridge, MA)
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 colleagues to provide labeling input relevant to clinical study protocols in early and late development.
- Contribute to discussions on clinical endpoint selection and integration of patient experience data to maximize labeling value.
- Assist in 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.
- Provide mentoring and training to more junior labeling strategists and support process improvements.
Qualifications:
- Knowledge of global regulatory labeling requirements, particularly US and EU.
- Ability to interpret clinical data and protocols with respect to regulatory labeling implications.
- Collaborative communication skills; ability to work effectively across functions.
- Attention to detail and organizational skills to manage multiple deliverables.
- Proactive approach; ability to work independently and under supervision.
- Strong stakeholder management skills.
Experience/Education:
- Bachelor’s degree in life sciences, pharmacy, or medically related field required; advanced degree (PharmD, PhD, MD or MSc) preferred.
- Minimum 8+ years pharmaceutical industry experience; 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 its regulatory relevance is advantageous.
Benefits (explicitly stated):
- High-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.
- 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 colleagues to provide labeling input relevant to clinical study protocols in early and late development.
- Contribute to discussions on clinical endpoint selection and integration of patient experience data to maximize labeling value.
- Assist in 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.
- Provide mentoring and training to more junior labeling strategists and support process improvements.
Qualifications:
- Knowledge of global regulatory labeling requirements, particularly US and EU.
- Ability to interpret clinical data and protocols with respect to regulatory labeling implications.
- Collaborative communication skills; ability to work effectively across functions.
- Attention to detail and organizational skills to manage multiple deliverables.
- Proactive approach; ability to work independently and under supervision.
- Strong stakeholder management skills.
Experience/Education:
- Bachelor’s degree in life sciences, pharmacy, or medically related field required; advanced degree (PharmD, PhD, MD or MSc) preferred.
- Minimum 8+ years pharmaceutical industry experience; 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 its regulatory relevance is advantageous.
Benefits (explicitly stated):
- High-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.