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Regulatory Labeling Manager
Eingestellt von Synectics
Gesuchte Skills: Support
Projektbeschreibung
PRIMARY RESPONSIBILITIES
- Utilize regulatory expertise to review, develop and deliver labeling documents to support submissions to the Regulatory Authorities across regions, requesting advice or input from other functions when appropriate.
- Production of other labeling-related documentation for submission such as track change versions, annotated labels, comparison tables and annotated supportive documentation.
- The full range of labeling documentation may be produced, including labels for New Chemical Entities or Product Extensions, as well as other complex revisions.
- For deliverables in scope, support responses to inquiries from colleagues in response to inspection activities and may provide support during regulatory agency questions.
- May mentor or train more junior labeling managers in their day-to-day activities
- May coordinate complex labeling activities when there is a regional, global or therapeutic area impact across multiple countries
- May lead regional SME forums on labeling processes and clearly articulate expectations of the labeling process to a broad range of stakeholders.
- Interprets internal/external business challenges and best practices to recommend improvements to products, processes, or services.
- Takes appropriate risks to advance innovative processes and methodologies based on comprehensive business knowledge.
- May represent the function or region on project improvement initiatives.
- Leads operational teams within and across Work Teams and Departments, taking responsibility for the team's milestones/deliverables.
- Contributes to definition of goals and group targets, and proactively feeds back issues and roadblocks to senior management.
- Meets strategic targets for labeling deliverables as defined for the function, and communicates progress against these targets or issues which affect these targets, and proposes remediation.
SKILLS:
- 4-7 years advanced Word experience
- Proficient in English with excellent written and verbal skills.
- Fluent (able to read, write and speak) in Spanish.
- A pharmacist or nurse is preferred.
EDUCATION:
- Life sciences, pharmacy graduate or equivalent
- Advanced academic qualifications/degree such as PhD an advantage but not essential
EXPERIENCE:
- Significant Hands on' registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs (Human Medicinal Products); preferably from the perspective of a Country office or Regional Regulatory Strategy important and advantageous
- Proven ability to successfully understand regulatory implications of product strategy with regard to the produce label, assessment and practical management of associated impacts.
- Demonstrated ability to interpret and apply regional/local regulatory guidance around labeling and associated supportive documentation, both in the pre-approval and post approval (maintenance) stages
- Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.
- Knowledge of global/regional regulatory guidelines and requirements important
- Regulatory affairs experience
- Experience with authoring country specific labels based on the Core Data Sheet or another country's Reference Labels
Projektdetails
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Einsatzort:
New York, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
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Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Sonstiges