Associate Director, Regulatory Translations

1 week ago

London, Greater London, United Kingdom Novartis Full time £60,000 - £120,000 per year

Job Description Summary

#LI-Hybrid (12 days per month on-site)
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.

Job Description

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.

Skills Desired

Clinical Trials, Cross-Functional Teams, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Problem Solving Skills, Regulatory Compliance, Risk Management

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