Associate Director, Regulatory Translations

Novartis; Greater London; Hybrid; GBP 80,000 - 100,000; Full time

Job summary

A global healthcare leader located in London is looking for a Team Lead for Regulatory Translation Solutions. The successful candidate will be responsible for leading regulatory translation efforts, ensuring compliance, and managing vendor relationships. Proven leadership and excellent communication skills are essential, along with a strong compliance mindset. This position offers a full-time contract and the possibility of hybrid work arrangements.

Qualifications

• Proven Leadership skills and accountability for budget.
• Excellent verbal and written communication skills.
• Experience in vendor management and team development.
• Strong compliance mindset with the ability to embrace new technologies.

Responsibilities

• Provide strategic guidance to the team in alignment with regulatory strategies.
• Ensure compliance excellence in collaboration with the Process Training and Compliance team.
• Maintain communication with key stakeholders and represent the group in leadership meetings.

Skills

Clinical Trials

Cross-Functional Teams

Detail-Oriented

Drug Development

Negotiation Skills

Problem Solving Skills

Regulatory Compliance

Risk Management

Job description

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 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

Key Skills

• Program assessment
• FDA Regulations
• Manufacturing & Controls
• Program Evaluation
• budget forecast
• Research Experience
• Operations Management
• Research & Development
• Strategic Planning
• Contract Management
• Leadership Experience
• negotiation

Employment Type :

Full-Time

Experience:

years

Vacancy:

1