Senior Specialist, Regulatory & PV Network

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

📋 Description

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

• Lead and functionally represent projects of medium to high complexity, ensuring efficient coordination and management of regulatory deliverables, motivating the team to achieve established targets while adhering to agreed procedures, trackers, and templates.

• Collaborate with a senior team member to develop strategies and manage setup activities (Project Management Plan, joint operating procedures, POAs, and core documents).

• Offer strategic insights to internal and external stakeholders, promptly identifying and addressing risks or potential risks by implementing preventative measures.

• Troubleshoot and support the resolution of performance issues or delivery failures effectively.

• Gather, review, track, and maintain CVs, job descriptions, training records, contact information, and monthly reports for LCPs.

• Ensure proper training assignment and compliance for LCPs.

• Guarantee that all team members involved in project departmental deliverables are informed of their tasks and time allocations, monitoring project budgets, hours worked versus budgeted, and promptly identifying and escalating any out-of-scope issues.

• Assist in proposal development and budget inputs, providing departmental representation in BD meetings as necessary.

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

• Offer training, coaching, and mentoring to junior staff members.

• Cultivate professional relationships with internal and external contacts at both local and international levels to ensure smooth and efficient service delivery.

• Keep updated on evolving regulatory legislative requirements, maintaining the regulatory intelligence database, and promptly disseminating relevant changes.

• Participate in and/or support junior team members in audit/inspection preparations, providing departmental representation for assigned projects as needed.

• Track key performance indicators for LCPs and prepare monthly summary reports.

• Provide performance feedback on vendors to assist in their evaluation.

• Contribute to departmental and company initiatives and assist in the design/review of SOPs, working practices, and guidance.

⛳️ Requirements

• Bachelor's Degree in Chemistry, Life Sciences, Nursing, or equivalent experience.

• Significant experience in the pharmaceutical or CRO industry or within a Regulatory body.

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

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

• Proficient in English, both written and spoken.

• Candidates must be fluent in the official language of their country of residence, as this is essential for local interactions and compliance.

• Proficiency in German, French, or Italian is advantageous, but not a requirement.

• Strong planning and organizational abilities.

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

• Keen attention to detail.

🏝️ Benefits

• Opportunities for training and career advancement internally.

• Strong focus on personal and professional growth.

• Friendly and supportive work environment.

• Opportunity to collaborate with colleagues worldwide, with English as the company’s primary language.