Regulatory Affairs Manager

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

📋 Description

• Drive regulatory achievements in the Polish market while overseeing significant client projects across a varied healthcare portfolio.

• Assist in regulatory strategies, submissions, lifecycle management, and interactions with authorities for products governed in Poland.

• Secure and uphold marketing authorizations, directing submission and lifecycle management efforts.

• Engage with health authorities, providing guidance on regulatory strategies.

• Organize project execution in accordance with established timelines and performance indicators.

• Cultivate and sustain robust client relationships while identifying potential for enhanced service support.

• Prepare, review, and compile regulatory documentation for submissions, renewals, variations, and lifecycle maintenance tasks.

• Assist in scientific advice procedures and represent clients in dealings with health authorities in Poland.

• Plan and implement client projects following established performance metrics.

• Offer regulatory consultancy to colleagues and clients regarding regulatory strategies and process management.

• Monitor and utilize regulatory intelligence, disseminating pertinent updates and insights within the team.

• Deliver seminars and lectures for colleagues, clients, and professional audiences.

• Aid in the execution of department strategies and ongoing process optimization.

• Ensure compliance, maintenance, and enhancement of internal regulatory and operational processes.

• Manage regulatory quality documentation, controlled records, and submission-support materials for designated products, processes, or client engagements.

• Review change controls, deviations, quality events, and associated records to assess regulatory impact and facilitate compliant outcomes.

• Contribute to the preparation, maintenance, and updating of filings, registrations, certifications, and post-approval modifications.

• Analyze regulations, standards, and internal procedures to identify deficiencies, escalate unusual issues, and suggest actionable next steps.

• Maintain audit-ready tracking tools, documentation logs, and status reports.

⛳️ Requirements

• Bachelor's degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality management, or a related discipline, or equivalent experience is required.

• Polish (native proficiency) and English (business conversational) - essential.

• A minimum of 2 years of experience in regulatory affairs, quality assurance, compliance, documentation control, or a related field is required.

• Demonstrated experience in regulatory affairs or a related field necessitating strong technical and practical regulatory knowledge.

• Significant hands-on experience managing new submissions and lifecycle management activities for medicinal products in Poland.

• Familiarity with adjacent product categories such as medical devices, cosmetics, food supplements, or herbal products is an advantage.

• In-depth understanding of Polish regulatory requirements and procedures.

• Ability to implement tactical objectives across client and internal projects.

• Proven capability to manage multiple priorities, recognize risks, and take necessary actions to keep projects on schedule.

• Organized, analytical, systematic, and independent working style.

• Strong problem-solving skills with a practical and service-oriented approach.

• Experience in mentoring junior colleagues and coordinating smaller project teams.

• Excellent relationship management skills with both day-to-day operational contacts and client leadership.

• Exceptional written and verbal communication abilities, including the capacity to present issues and recommendations clearly to decision-makers.

• Strong presentation skills and a confident, professional demeanor.

• Familiarity with Veeva Vault is considered a plus.

🏝️ Benefits

• Benefit offerings outside the US may vary by country and will be aligned with local market practices.

• Eligibility and effective dates may differ for some benefits and for team members covered under collective bargaining agreements.