Associate Director, Regulatory Translations

Job Description 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.

 

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