Senior Manager, Regulatory Intelligence and Analytics

📋 Description

• Take on a leadership role and serve as a functional representative for medium to high complexity projects, ensuring efficient coordination and management of regulatory deliverables.

• Conduct quality assurance on regulatory intelligence screening related to legislative requirements and maintain the regulatory intelligence database.

• Offer strategic regulatory insights to both internal and external clients, quickly identifying and addressing any risks or potential risks by implementing preventive measures.

• Ensure adherence to company protocols, processes, training documentation, systems, and other relevant tools.

• Assist in proposal development and budget input, as well as represent the department in BD meetings when necessary.

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

• Cultivate professional relationships with both internal and external stakeholders at local and international levels.

⛳️ Requirements

• A 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.

• Familiarity with the Pharmacovigilance and Regulatory fields.

• Comprehensive understanding of ICH GCP and/or GVP, as well as national regulations pertinent to the areas of competence.

• Proficient in English, both written and verbal.

• Knowledge of additional languages is a plus.

• Excellent organizational skills and a keen attention to detail in work.

🏝️ Benefits

• Opportunities for training and career development within the organization.

• Strong focus on personal and professional advancement.

• A friendly and supportive work environment.

• Chance to collaborate with colleagues globally, with English as the primary language of communication.