Regulatory Affairs professional overseeing high-quality translations essential for product registration and compliance at Novartis. Focusing on talent management and technology implementation within regulatory translation solutions.
Responsibilities
Provides strategic guidance to a team composed of direct reports and vendors, in alignment with regulatory strategies.
Ensures the selection of qualified talent (team members and vendors) to meet regulatory translation demands.
Ensures compliance excellence in collaboration with Process, Training and Compliance Team.
Implements state-of-the-art technologies to accelerate high-quality translations and facilitate submissions as necessary.
Updates vendors' or service providers' Statements of Work (SoWs) and supervises the team budget as required.
Has global financial competence over team activities.
Responsible for “Regulatory Translation Solution” group working practices, business guidance, scope-of-services, vendors' guidance, maintenance of terminological termbases, and the provision of relevant trainings to COs regarding Regulatory Translation Solutions group processes as necessary.
Serves as the Subject Matter Expert (SME) for working practices and/or GOPs involving regulatory translations.
Maintains clear and regular communication channels with key stakeholders.
Represents the “Regulatory Translation Solutions group” in leadership meetings as required.
Requirements
Proven Leadership skills- member of leadership team, accountable for budget etc.
Excellent verbal and written communication skills.
Proven People Management skills preferred include recruiting, retaining and team development.
Experience in vendor management (customer oriented).
Forward thinker with the ability to embrace new technologies as necessary.
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