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Global Labeling Strategist - Bridgewater, United States - Sanofi-Aventis Belgium S.A.
Description
Sanofi Global Regulatory Affairs, Global Labeling team is looking for a motivated individual to help lead labeling strategy for products in the rare blood and rare disease portfolio.
Reporting through Global Regulatory Affairs (GRA), the candidate will work collaboratively with both internal and external stakeholders leading the labeling strategy for the company core position and the US and EU affiliates This individual will work closely with subject matter experts within Sanofi to assess the impact of competitive intelligence on the company's products and goals.
Job Responsibilities:
Lead and support cross-functional teams as a labeling expert and contribute to the definition of global regulatory strategies and to the preparation of submission dossiers or responses to Health Authorities:
Prepare corporate labeling documents (Core Data Sheet or Core Safety Information), US and EU Summary of Product Characteristics and patient leaflet for projects and marketed products within the framework of regulatory submissions to obtain new Marketing Authorizations or to update existing Marketing Authorizations.
Coordinate the presentation of these proposals to the Senior Executive Management via a Labeling Governance Committee. Coordination of review of local labeling to assure compliance with corporate labeling policies. Lead labeling negotiations with agencies resulting in product approvals or labeling updates. To take into account and assess development study reports, pharmacovigilance data (post-marketing) and any other scientific reports. Approve final proof of labeling artworks according to established responsibilities.Support local countries in implementing labeling changes
Practical experience in Regulatory Affairs, Pharmacovigilance, or Medical Affairs
Specific Requirements:
Knowledge and experience in European and US HA regulations and international regulatory environment,
Minimum education level required is PharmD, PhD, MD or equivalent advanced degree
Five (5) years of pharmaceutical experience within regulatory affairs required
Soft Skills:
Excellent written and verbal communication skills
Negotiation skills
Demonstrated ability to solve problems and proactivity
Ability to work with multifunctional and culturally diverse teams
Organizational skills
Ability to manage multiple projects at short notice
Excellent interpersonal skills
Autonomy, rigor, fluent business English
Pursue
progress , discover
extraordinary
Better is out there. Better medications, better outcomes, better science.
But progress doesn't happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing:
a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
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