Associate Director, Global Labeling Lead
Scorpion Therapeutics, Berkeley Heights, New Jersey, us, 07922
Role Summary
Locations: Cambridge, US; Gaithersburg, US; London, United Kingdom; New Jersey, US. You will be a member of the Global Labeling, Global Regulatory Affairs team and will lead all Labeling activities required for the development and maintenance of the Company Core Data Sheet, US prescribing and patient information and EU CP prescribing and patient information for BioNTech commercial products. In your role, you will act globally and work cross-functionally. Responsibilities
Define and execute Labeling strategy for global life cycle management of medicinal products in BioNTech's responsibility for Primary Reference Labeling (i.e., the Company Core Data Sheet (CCDS), US Prescribing Information (USPI) and EU CP Summary of Product Characteristics [SmPC]). The strategy comprises management of local market label dependencies and country label differences when the local markets identify a need to review Primary Reference at the Labeling Team level Build and lead cross-functional Labeling Teams Responsible for timely preparation of Primary Reference labeling updates following update of the CCDS or on request of competent Health Authorities Ensuring timely communication of updated CCDS content to local country offices for MAs in BioNTech’s responsibility Lead development and maintenance of regulatory processes and systems for Global Labeling Identify critical Regulatory Labeling issues and proactively implement activities for their resolution including leading initiatives for Labeling within GRA or across functions at BioNTech Act as the empowered delegate for the Head of Global Labeling as necessary Qualifications
Degree in pharmacy, chemistry, biology, biochemistry, medicine or equivalent Advanced degree preferred, but not required 9-16 years of professional working experience in Regulatory Affairs globally during development, registration and/or post-marketing for Biologics, Vaccines and/or Small Molecules, including direct experience in strategic Labeling content development and management and interacting with Health Authorities Profound experience in leading the preparation and revision of product prescribing (and corresponding patient) information during registration and/or post-marketing, for CCDSs, EU CP SmPCs and USPIs In depth knowledge of EMA and FDA regulatory requirements for product prescribing and patient information Ability to work independently on very complex projects with minimal oversight Excellent verbal and written communication skills in English
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Locations: Cambridge, US; Gaithersburg, US; London, United Kingdom; New Jersey, US. You will be a member of the Global Labeling, Global Regulatory Affairs team and will lead all Labeling activities required for the development and maintenance of the Company Core Data Sheet, US prescribing and patient information and EU CP prescribing and patient information for BioNTech commercial products. In your role, you will act globally and work cross-functionally. Responsibilities
Define and execute Labeling strategy for global life cycle management of medicinal products in BioNTech's responsibility for Primary Reference Labeling (i.e., the Company Core Data Sheet (CCDS), US Prescribing Information (USPI) and EU CP Summary of Product Characteristics [SmPC]). The strategy comprises management of local market label dependencies and country label differences when the local markets identify a need to review Primary Reference at the Labeling Team level Build and lead cross-functional Labeling Teams Responsible for timely preparation of Primary Reference labeling updates following update of the CCDS or on request of competent Health Authorities Ensuring timely communication of updated CCDS content to local country offices for MAs in BioNTech’s responsibility Lead development and maintenance of regulatory processes and systems for Global Labeling Identify critical Regulatory Labeling issues and proactively implement activities for their resolution including leading initiatives for Labeling within GRA or across functions at BioNTech Act as the empowered delegate for the Head of Global Labeling as necessary Qualifications
Degree in pharmacy, chemistry, biology, biochemistry, medicine or equivalent Advanced degree preferred, but not required 9-16 years of professional working experience in Regulatory Affairs globally during development, registration and/or post-marketing for Biologics, Vaccines and/or Small Molecules, including direct experience in strategic Labeling content development and management and interacting with Health Authorities Profound experience in leading the preparation and revision of product prescribing (and corresponding patient) information during registration and/or post-marketing, for CCDSs, EU CP SmPCs and USPIs In depth knowledge of EMA and FDA regulatory requirements for product prescribing and patient information Ability to work independently on very complex projects with minimal oversight Excellent verbal and written communication skills in English
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