Team Lead Regulatory Translations

Novartis Farmacéutica; London; Hybrid; GBP 60,000 - 90,000; Full time

Job summary

A leading pharmaceutical company is seeking a Regulatory Translation Solution Manager to oversee translation strategies and compliance. This hybrid role requires strong leadership and vendor management skills, with a focus on regulatory affairs and team guidance. Ideal candidates will have a bioscience degree and significant experience in the pharmaceutical field, along with the ability to implement advanced technologies to improve translation processes.

Qualifications

• 8+ years experience in project and vendor management with CROs.
• Fluency in English is required; proficiency in other languages is a plus.
• Knowledge of Regulatory Affairs in the Pharmaceutical industry preferred.

Responsibilities

• Lead and manage a team for regulatory translation compliance.
• Select and manage vendors to meet translation demands.
• Oversee stakeholder communication and lead discussions in meetings.

Skills

Leadership

Communication

Compliance

Project Management

Vendor Management

Education

University degree in bioscience

Master’s or PhD in molecular biology or biochemistry

Tools

Veeva Volt

Job description

Oversees the provision of timely, high-quality regulatory translations essential for product registration, maintenance, and launches worldwide.

About the Role

Key Requirements

Team leadership and strategic guidance

• Provides strategic guidance to a team composed of 5-6 direct reports and vendors, in alignment with regulatory strategies. Previous Vendor Management with CRO’s is a must.
• Ensures the selection of qualified talent (team members and vendors) to meet regulatory translation demands.

Compliance and implementation

• Ensures compliance excellence in collaboration with Process Transformation & Learning.
• 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

Decision-making and standard practices

• Strategizes, oversees and supervisesRegulatory Translation Solution group working practices, business guidance, scope-of-services, vendors' guidance, maintenance of terminological term bases, and the provision of relevant trainings to COs regarding Regulatory Translation Solution group processes as necessary.
• Serves as the Subject Matter Expert (SME) for working practices and/or Standard Operating Procedures involving regulatory translations.

Stakeholder communication

• Maintains clear and regular communication channels with key stakeholders.
• Represents the Regulatory Translation Solution group in leadership meetings as required and maintains clear and regular communication channels with key stakeholders.

This role will be hybrid, requiring 3 days per week in our London office.

Your Experience

• A university degree in a bioscience (e.g., biology, medicine, pharmacy, or biochemistry) or extensive experience in medical/pharmaceutical translation.
• A master’s or PhD in molecular biology or biochemistry is especially preferred.
• Fluency in English (both written and spoken). Proficiency in other languages, is desirable but not essential
• Ideally must have around 8 years + experience. Project Management, vendor management with CROs & translations. This will require you to be customer oriented with strong communication skills
• Leadership experience combined with excellent communication skills, team building and performance driven compliance.
• Working knowledge of Regulatory Affairs in the Pharmaceutical industry or with CRO’s is desirable.
• Forward thinker with the ability to embrace new technologies & be tech savvy, experience with Veeva Volt would be nice to have.
• Strong compliance mindset

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.

Functional Area Research & Development

Job Type Full time

Employment Type Regular

Shift Work No

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.