摘要
Location: London (The Westworks), United Kingdom
Internal Title: Team Lead, Regulatory Translation Solutions
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.
About the Role
Major Accountabilities
- 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.
Essential 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.
- 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 team’s 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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
