We are seeking a strategic and experienced Regulatory Affairs professional to oversee the provision of timely, high-quality regulatory translations essential for product registration, maintenance, and launches worldwide.
* 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.
* 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.
* Strong compliance mindset.
Desirable Requirements
* Working knowledge of Regulatory Affairs.
Commitment to Diversity & Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
https://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards
Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
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