Local coordination and execution of regulatory submissions in compliance with corporate standards and local regulatory requirements.
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Execution of the preparation, delivery and electronic archiving of documentation for inclusion in local regulatory submissions.
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Coordination and execution of Regulatory Affairs processes and deliverables in the local office.
Responsibility:
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Ensures regulatory submissions are made on time and meet company’s corporate and local regulatory requirements.
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Creates and reviews source text for country labeling.
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Reviews promotional and non-promotional materials.
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Coordinates translation for local Regulatory submission,
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Exchanges regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner.
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Partners with Regional Regulatory Leads (RRLs) to support the regulatory development, registration, and lifecycle management of all company molecules.
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Partners with peers to ensure consistency on procedures
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Assists locally in Healthcare Compliance activities, where applicable.
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Participates in local regulatory process improvements, initiatives and training.
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Oversees external vendor/contractor relationships, where applicable.
Requirements:
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Bachelor’s degree in scientific area or related
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Knowledge of Regulatory principles.
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Working with policies, procedures and SOP’s.
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Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
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Understanding of drug development.
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Demonstrate ability to work in teams.
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Ability to understand and communicate scientific/clinical information