Senior Specialist, Regulatory & PV Network

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

📋 Description

• Formulate regulatory strategies in alignment with regulatory requirements.

• Propel regulatory and pharmacovigilance objectives as per established timelines.

• Serve as the Local Contact Person for Pharmacovigilance in the specified country.

• Lead and represent projects of medium to high complexity while coordinating regulatory deliverables.

• Create strategies and oversee project initiation activities, which include project management plans, joint operating procedures, powers of attorney, and foundational documents.

• Offer strategic insights to both internal and external stakeholders.

• Identify and mitigate risks through proactive measures.

• Address performance challenges and rectify delivery shortcomings.

• Gather, assess, monitor, and maintain Local Contact Person records, training documentation, contact information, and monthly reports.

• Ensure appropriate training assignments for the Local Contact Person and adherence to compliance standards.

• Oversee project budgets, hours worked, and any out-of-scope tasks.

• Assist in the development of proposals and participate in business development meetings.

• Prepare client invoices and review/approve vendor project invoices.

• Train, mentor, and guide junior team members.

• Foster professional relationships with both internal and external connections.

• Keep abreast of evolving regulatory requirements and maintain the regulatory intelligence database.

• Aid in the preparation for audits and inspections.

• Monitor key performance indicators for the Local Contact Person and generate monthly reports.

• Provide feedback on vendor performance.

• Contribute to departmental and company initiatives, standard operating procedures, work practices, and guidance.

⛳️ Requirements

• Bachelor’s Degree in Chemistry, Life Sciences, Nursing, or a related field.

• Extensive experience in the pharmaceutical, CRO industry, or regulatory agency.

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

• PV training and/or relevant working experience and other educational or professional qualifications as required locally.

• Proficient in English, both written and spoken.

• Competent in the official language of the country where the position is based.

• Strong planning and organizational abilities.

• Excellent interpersonal skills in a dynamic, deadline-driven, and evolving environment.

• High attention to detail.

🏝️ Benefits

• Availability for remote work.

• Flexible work environment.

• Opportunities for professional growth.

• A collaborative and supportive team culture.

• A workplace that fosters belonging and inclusivity.

• Professional development opportunities through training, coaching, and mentoring.

• Exposure to global work and international collaboration.