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
Salary
Competitive
Monthly based
Location
London, England, United Kingdom
Job Overview
Location
London, England, United Kingdom