Team Lead Regulatory Translations

Novartis Farmacéutica; London; Hybrid; GBP 75,000 - 95,000; Full time

Job summary

A global biopharmaceutical company in London is seeking a Regulatory Translation Manager to oversee strategic guidance and compliance in regulatory translations. The ideal candidate has over 8 years of experience in the pharmaceutical industry, strong leadership skills, and fluency in English. This hybrid role combines office presence and flexibility, promising a collaborative environment focused on patient care and innovative solutions.

Qualifications

• Fluency in English (written and spoken), proficiency in other languages is desirable.
• 8+ years of experience in project management and vendor management with CROs.
• Strong compliance mindset and experience with regulatory affairs in the pharmaceutical industry.

Responsibilities

• Provide strategic guidance to a team and ensure compliance excellence.
• Oversee vendor selection and supervise the team budget.
• Maintain communication with key stakeholders and represent the group in leadership meetings.

Skills

Team leadership

Communication

Project Management

Vendor Management

Regulatory Affairs

Education

University degree in bioscience (biology, medicine, pharmacy, 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.
• 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.

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