Associate Director, Regulatory Translations

Summary

Office Location: London (The Westworks), United Kingdom
#LI-Hybrid Hybrid (12 days per month on-site if living within 50 miles to our London office)
#LI-Remote Remote (if living beyond 50 miles to our London office)
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.

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