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Regulatory Affairs Manager
Recruiting.comRegulatory Affairs Manager overseeing Polish market regulatory success and client project leadership in healthcare. Supporting regulatory strategy and compliance for various healthcare products.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in regulatory affairs, particularly in managing marketing authorizations and lifecycle management for medicinal products in Poland. Possesses strong communication and relationship management skills to effectively interact with health authorities and clients.
Highest-signal resume keywords
Regulatory Affairs ExperiencePolish Regulatory KnowledgeLifecycle ManagementClient Project ManagementRegulatory Submissions
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Regulatory StrategySubmission ManagementLifecycle Management ActivitiesRegulatory Documentation PreparationRegulatory Intelligence MonitoringSOP CreationChange Control ReviewQuality Event AnalysisTechnical Regulatory KnowledgeExperience with Medicinal Products
Soft Skills
Problem-Solving AbilityRelationship ManagementAnalytical Working StyleService-Oriented MindsetExcellent Communication Skills
Certifications & Qualifications
Bachelor's Degree in Life SciencesPharmacyChemistryBiomedical SciencesEngineeringQuality Management
Industry Keywords
Healthcare PortfolioMarketing AuthorizationsHealth AuthoritiesEU Regulatory ActivitiesMedical DevicesCosmeticsFood SupplementsHerbal Products
About the role
Key responsibilities & impact- 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.
- Manage regulatory activities and client projects focused on Polish market requirements.
- Maintain and secure marketing authorizations, leading submission and lifecycle management activities.
- Communicate with health authorities and advise on regulatory strategy.
- Coordinate project execution in line with agreed timelines and KPIs.
- 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.
- Monitor and apply regulatory intelligence, sharing relevant updates and insights across the team.
- Comply with, maintain, and improve internal regulatory and operational processes including creation of SOPs and working instructions, as required.
- Review change controls, deviations, quality events, and related records to identify regulatory impact and support compliant disposition.
Requirements
What you’ll need- Bachelor's degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality management, or a related field, or equivalent experience required.
- 3+ years of experience in regulatory affairs for marketing authorizations in Poland.
- 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.
- Additional experience in regulatory activities in the EU is welcomed.
- 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.
- 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.
Benefits
Comp & perks- 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.