Regulatory Affairs Manager

PharmaLex; Warszawa; On-site; PLN 180,000 - 240,000; Full time

Job summary

PharmaLex in Warsaw is seeking a Regulatory Affairs Manager for Poland to lead regulatory strategy, submissions, and lifecycle management for human and related products.

You will build strong client relationships, coordinate cross‑functional teams, and interact with Polish health authorities to secure marketing authorisations and ensure compliant project delivery.

Qualifications

• Bachelor's degree or equivalent in life sciences or related field.
• Polish (native) and English (business) required.
• 3+ years' regulatory affairs experience for Poland.
• Experience with marketing authorisations and lifecycle management.
• Knowledge of Polish regulatory requirements and procedures.
• Experience with EU regulatory activities is a plus.

Responsibilities

• Develop and maintain strong client relationships and identify opportunities for expanded service support.
• Lead regulatory activities to obtain and maintain marketing authorizations with focus on Poland.
• Prepare, review, and compile regulatory documentation for submissions, renewals, variations, and lifecycle maintenance.
• Communicate with clients and Polish Health Authorities.
• Support regulatory strategy and procedural management across projects.
• Monitor regulatory intelligence and share updates across the team.
• Maintain and improve internal regulatory processes and SOPs.
• Coordinate regulatory quality documentation and submission materials.

Skills

Regulatory affairs

Client relationship management

Project leadership

Communication skills

Polish language

Education

Bachelor's degree in life sciences

Tools

Veeva Vault

Job description

Job Details

Regulatory Affairs Manager - Poland

Advance regulatory success in the Polish market while leading high-value client projects across a diverse healthcare portfolio.

We are seeking an experienced and client-focused Regulatory Affairs Manager - Poland to support regulatory strategy, submissions, lifecycle management, and authority interactions for products regulated in Poland. This is a strong opportunity for a regulatory professional who combines deep local market knowledge with project leadership, client relationship management, and a practical, solutions-oriented approach.

In this role, you will support projects involving human and veterinary medicinal products, as well as selected adjacent product categories such as medical devices, cosmetics, food supplements, and herbal products, helping clients navigate Polish regulatory requirements with confidence and efficiency.

About The Role

The Regulatory Affairs Manager - Poland is responsible for managing regulatory activities and client projects focused on Polish market requirements. The role includes maintaining and securing marketing authorizations, leading submission and lifecycle management activities, communicating with health authorities, advising on regulatory strategy, and coordinating project execution in line with agreed timelines and KPIs.

This position is ideal for a professional who can build trusted client relationships, provide high-quality regulatory consultancy, coordinate project teams, and contribute to operational excellence across the broader function.

What You’ll Do

• Develop and maintain strong client relationships and identify opportunities for expanded service support
• Participate in and lead regulatory activities to obtain and maintain marketing authorizations with a focus on Human medicinal products, while also
  • Veterinary medicinal products
  • Medical devices
  • Cosmetics
  • Food supplements
  • Herbal products can be in scope. Primary focus is Polish regulatory requirements
• Prepare, review, and compile regulatory documentation for submissions, renewals, variations, and lifecycle maintenance activities
• Communicate directly with clients and Polish Health Authorities
• 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
• Comply with, maintain, and improve internal regulatory and operational processes including creation of SOPs and working instructions, as required
• 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
• Maintain audit‑ready tracking tools, documentation logs, and status reporting

What We’re Looking For

• Bachelor's degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality management, or a related field, or equivalent experience required.
• Language Requirement: Polish (Native level) and English (Business conversational) - Essential
• 3+ years of experience in regulatory affairs for marketing authorizations in Poland, additional background in quality assurance, compliance, documentation control, or a related field is appreciated
• 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
• Experience with Veeva Vault is appreciated.

Why Join Us

This is an opportunity to take on a visible and impactful role in a dynamic consulting environment, where your expertise in Polish regulatory affairs will directly support client success. You will work across a broad range of regulatory projects, contribute strategic insight, and help clients navigate complex requirements in a changing healthcare landscape.

For professionals seeking a role that combines regulatory depth, project ownership, and client partnership, this position offers meaningful scope and growth.

Ideal Candidate

You are a proactive and dependable regulatory leader who enjoys combining technical expertise with strong client service. You are comfortable managing complex submissions, advising on regulatory pathways, coordinating stakeholders, and ensuring high‑quality execution across multiple priorities. You bring sound judgment, strong organizational skills, and a collaborative approach to solving regulatory challenges.

Apply Now

If you are ready to bring your expertise in Polish regulatory affairs to a collaborative and growing environment, we encourage you to apply.

Certification in regulatory affairs, quality management, compliance, auditing preferred.

What Cencora offers

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.

Affiliated Companies

Affiliated Companies: DRA Consulting Oy

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non‑discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [e-mail]. We will make accommodation determinations on a request‑by‑request basis. Messages and emails regarding anything other than accommodations requests will not be returned.