Senior Specialist, Regulatory & PV Network

This is a fully remote position, open to applicants in Serbia, +1 more country.

📋 Description

• Formulate regulatory strategies in accordance with regulatory guidelines.

• Propel regulatory and pharmacovigilance outcomes in alignment with outlined plans.

• Act as the intermediary between regulatory teams and other functional departments, external partners, clients, authorities, and consultants.

• Function as the Local Contact Person for Pharmacovigilance in the designated country.

• Lead and represent medium to high-complexity projects functionally.

• Organize and oversee regulatory deliverables, ensuring adherence to targets and procedures.

• Develop strategic plans and manage project initiation activities, including project management plans, joint operating procedures, POAs, and core documentation.

• Offer strategic insights and proactively identify and mitigate risks.

• Address performance challenges and rectify delivery shortcomings.

• Maintain LCP CVs, job descriptions, training records, contact information, and monthly reports.

• Ensure compliance with LCP training assignments.

• Supervise project tasks, time allocations, budgets, and any out-of-scope work.

• Assist in proposal development, budget planning, and business development meetings.

• Prepare client invoices and review or authorize vendor project invoices.

• Train, mentor, and guide junior team members.

• Foster professional relationships with both internal and external stakeholders.

• Keep abreast of regulatory legislative changes and maintain the regulatory intelligence database.

• Aid in preparation for audits and inspections.

• Monitor LCP KPIs and generate monthly summary reports.

• Provide feedback on vendor performance.

• Contribute to company initiatives, SOPs, working practices, and guidelines.

⛳️ Requirements

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

• Significant experience in the pharmaceutical industry, CRO, or regulatory bodies.

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

• PV training and/or relevant work experience, along with any additional education or professional qualifications as required locally.

• Proficient in English, both spoken and written.

• Skilled in the official language of the country of residence.

• Strong planning and organizational capabilities.

• Excellent interpersonal skills in a dynamic, fast-paced environment with tight deadlines.

• Keen attention to detail.

🏝️ Benefits

• Availability of remote work options.

• Flexible working environment.

• Opportunities for professional growth.

• A collaborative and supportive team culture.

• Professional development through training, coaching, and mentoring.

• Global team engagement and international exposure.

• A workplace culture focused on belonging.