Senior Specialist, Regulatory & PV Network

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

📋 Description

• Formulate a regulatory strategy in alignment with regulatory requirements

• Drive pharmacovigilance and regulatory deliverables according to established plans

• Serve as the Local Contact Person for Pharmacovigilance in the assigned country

• Lead and represent projects of medium to high complexity

• Coordinate and oversee regulatory deliverables, guiding teams to achieve targets and adhere to procedures

• Develop strategies and manage project initiation activities, including Project Management Plans, joint operating procedures, POAs, and core documentation

• Offer strategic insights to both internal and external stakeholders

• Identify and mitigate risks by implementing preventive strategies

• Resolve issues and support the resolution of performance challenges or delivery failures

• Gather, review, track, and maintain LCP records, including CVs, job descriptions, training records, contact information, and monthly reports

• Ensure proper training assignments and compliance among LCPs

• Monitor project budgets, tracking hours worked against budgeted hours, and identify as well as escalate any out-of-scope work

• Assist in proposal development and budgeting, representing the department in business development meetings

• Prepare client invoices and review/approve vendor invoices for projects

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

• Cultivate professional relationships with internal and external contacts, both locally and globally

• Stay updated on evolving regulatory legislative requirements and maintain the regulatory intelligence database

• Participate in or assist with audit/inspection preparations

• Track key performance indicators for LCPs and compile monthly summary reports

• Provide feedback on vendor performance

• Contribute to departmental and company initiatives, including the design or review of SOPs, working practices, and guidance

⛳️ Requirements

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

• Extensive experience in the pharmaceutical industry, CRO, or regulatory body

• Solid understanding of ICH GCP and/or GVP along with national regulations pertinent to the areas of responsibility

• PV training and/or relevant work experience as well as other educational or professional qualifications as necessary locally

• Proficient in English, both in writing and speaking

• Skilled in the official language of the country of residence

• Strong planning and organizational abilities

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

• Keen attention to detail

🏝️ Benefits

• Flexible remote work options

• Opportunities for professional growth

• A collaborative and supportive team culture

• A global working environment

• Professional development through training, coaching, and mentoring

• Chance to collaborate with experts in clinical research, pharmacovigilance, and quality consulting