Associate Director, Regulatory Translations

London - UK

Monthly Salary: Not Disclosed

Posted on: 19 days ago

Vacancies: 1 Vacancy

Job Summary

Job Description Summary

#LI-Hybrid (12 days per month on-site if living within 50 miles to our London office) OR #LI-Remote (if living beyond 50 miles to our London office)
Office 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 teams 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

Required Experience:

Director

Job Description Summary#LI-Hybrid (12 days per month on-site if living within 50 miles to our London office) OR #LI-Remote (if living beyond 50 miles to our London office)Office Location: London (The Westworks) United Kingdom Internal Title: Team Lead Regulatory Translation SolutionsWe are seeking a...