Regulatory Affairs Manager

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Recruiting.com

WebsiteLinkedInAll Job Openings

11 - 50 employees

🎯 Recruiter

☁️ SaaS

🤝 B2B

💰 Private Equity Round on 2006-06

Recruitment • SaaS • B2B

Recruiting. com is a recruitment platform that collects personal and non-personal information from job seekers to be used by recruiters and hiring managers. Users can submit their resumes or fill out a short form to be considered for current and future job opportunities. The site emphasizes user privacy and allows users to manage their personal data, including modifying, changing, and deleting their information. Recruiting. com securely stores user data until they request deletion, providing a comprehensive recruitment solution for both job seekers and employers.

📋 Description

• Advance regulatory success in the Polish market while leading high-value client projects across a diverse healthcare portfolio. • Support regulatory strategy, submissions, lifecycle management, and authority interactions for products regulated in Poland. • Maintain and secure marketing authorizations, leading submission and lifecycle management activities. • Communicate with health authorities, advising on regulatory strategy. • Coordinate project execution in line with agreed timelines and KPIs. • Develop and maintain strong client relationships and identify opportunities for expanded service support. • Prepare, review, and compile regulatory documentation for submissions, renewals, variations, and lifecycle maintenance activities. • Support scientific advice procedures and represent clients in interactions with health authorities in Poland. • Plan and execute client projects in accordance with established KPIs. • Provide regulatory consultancy to colleagues and clients on regulatory strategy and procedure management. • Monitor and apply regulatory intelligence, sharing relevant updates and insights across the team. • Present seminars and lectures for colleagues, clients, and professional audiences. • Support department strategy implementation and continuous process optimization. • Comply with, maintain, and improve internal regulatory and operational processes. • Coordinate regulatory quality documentation, controlled records, and submission-support materials for assigned products, processes, or client engagements. • Review change controls, deviations, quality events, and related records to identify regulatory impact and support compliant disposition. • Support the preparation, maintenance, and update of filings, registrations, certifications, and post-approval changes. • Analyze regulations, standards, and internal procedures to identify gaps, escalate atypical issues, and recommend practical next steps. • Maintain audit-ready tracking tools, documentation logs, and status reporting.

🎯 Requirements

• Bachelor's degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality management, or a related field, or equivalent experience required. • Polish (Native level) and English (Business conversational) - Essential • 2+ years of experience in regulatory affairs, quality assurance, compliance, documentation control, or a related field required. • Proven experience in regulatory affairs or a related field requiring strong technical and practical regulatory knowledge. • Strong hands-on experience managing new submissions and lifecycle management activities for medicinal products in Poland. • Experience with adjacent product categories such as medical devices, cosmetics, food supplements, or herbal products is an advantage. • Strong knowledge of Polish regulatory requirements and procedures. • Ability to implement tactical goals across customer and internal projects. • Proven ability to manage parallel priorities, identify risks, and take action to keep projects on track. • Structured, analytical, systematic, and independent working style. • Strong problem-solving ability with a pragmatic and service-oriented mindset. • Experience supporting junior colleagues and coordinating smaller project teams. • Strong relationship management skills across both day-to-day operational contacts and client leadership. • Excellent written and verbal communication skills, including the ability to present issues and recommendations clearly to decision-makers. • Strong presentation skills and a confident, professional presence. • Experience with Veeva Vault is appreciated.

🏖️ Benefits

• Benefit offerings outside the US may vary by country and will be aligned to local market practice. • The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.