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Regulatory Labeling Manager

Eingestellt von Synectics

Gesuchte Skills: Support

Projektbeschreibung

The Labeling Manager is responsible for executing the content management of various labeling documents for nationally registered products across multiple countries/regions. The full range of labeling documentation may be produced. Also serves as a subject matter expert for local labeling and acts as a resource to the Regional Labeling Head and more junior Labeling Managers throughout the organisation, leading or assisting in the most complex labeling projects or initiatives, and contributing to the use and development of current and new tools, technologies and processes to support global label development, submission and approval. Sharing of intelligence and contribution to knowledge resources is also a key part of the role.

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

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

  • Skills:

    support

Synectics