Senior Specialist, Regulatory Intelligence and Analytics

This is a fully remote position, open to applicants in Poland.

📋 Description

• Lead and represent functional aspects of medium to high complexity projects, ensuring efficient coordination and management of regulatory deliverables.

• Conduct quality control on regulatory intelligence screenings of legislative requirements, maintaining the regulatory intelligence database, and ensuring timely updates on relevant changes.

• Offer strategic regulatory insights to both internal and external stakeholders, swiftly identifying and addressing any risks or potential risks through the implementation of preventive measures.

• Facilitate problem-solving and support the resolution of performance issues or delivery failures effectively.

• Ensure adherence to company procedures, processes, training records, systems, and other relevant tools.

• Deliver training, coaching, and mentorship to junior team members.

⛳️ Requirements

• Bachelor’s degree in Chemistry, Life Sciences, Nursing, or equivalent experience.

• Significant prior experience in the pharmaceutical or CRO industry, or with a regulatory body.

• Previous experience in project management is preferred.

• Knowledge of Pharmacovigilance and the Regulatory field.

• Strong understanding of ICH GCP and/or GVP, as well as national regulations applicable to the areas of expertise.

• Fluent proficiency in English, both written and spoken.

• Proficiency in additional languages is a plus.

• Excellent organizational skills with a detail-oriented work approach.

🏝️ Benefits

• Opportunities for training and career development within the organization.

• A strong focus on personal and professional growth.

• A friendly and supportive work environment.

• The chance to collaborate with colleagues from around the globe, with English as the primary language of communication.