Job Description

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

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 supervises Regulatory 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?
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.
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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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