Senior Manager, Regulatory Intelligence and Analytics

This is a fully remote position, open to applicants in Bosnia and Herzegovina.

📋 Description

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

• Guide the team in achieving established targets while adhering to approved procedures, trackers, and templates.

• Conduct quality control of regulatory intelligence screening concerning legislative requirements, and maintain the regulatory intelligence database while ensuring timely updates on relevant changes.

• Offer strategic regulatory insights to both internal and external stakeholders, quickly identify risks or potential risks, and implement preventative measures.

• Troubleshoot issues and facilitate the resolution of performance challenges or delivery shortcomings.

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

• Ensure all team members involved in the project are informed of their tasks and the time allocated to them.

• Monitor project budgets, comparing hours worked to budgeted hours, and promptly escalate any out-of-scope situations.

• Assist in the development of proposals and budget input.

• Represent the department in business development meetings as necessary.

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

• Build and maintain professional relationships with both internal and external contacts at local and international levels to ensure seamless service delivery.

• Engage in and/or support junior staff in audit/inspection preparations, and represent the department for assigned projects as required.

• Offer feedback on vendor performance to assist in their evaluation.

• Contribute to department and company initiatives, including the design and review of SOPs, working practices, and guidance documents.

⛳️ Requirements

• A degree in Chemistry, Life Sciences, Nursing, or equivalent experience.

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

• Project Management experience is preferred.

• Familiarity with the Pharmacovigilance and Regulatory fields.

• Solid understanding of ICH GCP and/or GVP as well as national regulations applicable to the relevant territories.

• Proficient in English, both written and spoken.

• Proficiency in additional languages is a plus.

• Strong organizational skills and a detail-oriented approach to work.

🏝️ Benefits

• Opportunities for training and career development within the organization.

• A strong focus on personal and professional growth.

• A friendly and supportive working environment.

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