Regulatory Affairs Specialist

2 tygodni temu

Warszawa, Mazovia, Polska The businesses of Merck KGaA, Darmstadt, Germany Pełny etat

This role can be done hybrid: 3 days per week from office in Warsaw.

Your role:

Ready to join our Polish affiliate? This is an exceptional opportunity for a dynamic Regulatory Affairs (RA) Specialist to drive the local life cycle management for our product portfolio. This pivotal role acts as the RA expert in Poland, leading all critical regulatory activity. You will be responsible for maintaining Marketing Authorizations and driving in-country submission management—from planning, dossier review, and final local submissions (including national product information and artwork approval).

You will serve as key point of contact for Health Authorities (HAs), ensuring quality control and cross-functional alignment with global strategy. Furthermore, you will provide essential support for new product registrations, including Early Access Programs, and oversee the review and approval of all promotional materials.

If you are a proactive person with deep knowledge of regulatory compliance and strong stakeholder management skills, this is your chance to directly enable patient access to our innovative portfolio.

Who you are:

  • University degree (Master's, PhD) in pharmaceutical science or an equivalent qualification with relevant work experience.
  • 2- 4 years of experience in the regulatory affairs field (RA proficiency).
  • Ability to execute assigned task independently, strong project management skills & proactive communication approach, very attentive to details.
  • High proficiency in English and in Polish language.
  • Following an aligned cross-functional end-to-end phase-in strategy for a successful registration and commercialization, mitigating business risks and ensuring compliance.
  • Stakeholder management, project management and communication skills are key requirements to excel in this position.
  • Ability to effectively design, prioritize, keep information confidential, escalate issues, manage time effectively, gain alignment and successfully execute future strategic activities.

YOUR MAIN BENEFITS:

  • Health and well-being: Get access to private medical care, life insurance, and sports card, 
  • Work-Life balance: Enjoy additional paid days off, hybrid working model.
  • Learning and Development: Take advantage of co-financing for language courses, trainings, and certifications as well as other development opportunities
  • Employee support and engagement: Benefit from Employee Assistance Program and join employee engagement groups for support and connection.

  • Senior Regulatory Affairs Specialist

    1 tydzień temu

    Warszawa, Mazovia, Polska IT Performance Pełny etat

    Dla naszego klienta, firmy z branży farmaceutycznej poszukujemy osoby na stanowisko Senior Regulatory Affairs Specialist, która obejmie kluczową rolę ekspercką w obszarze rejestracji leków.Jako Senior RA Specialist nie będziesz tylko "procesować papierów". Staniesz się strażnikiem jakości i kluczowym partnerem biznesowym dla innych działów.

  • Senior Regulatory Affairs Specialist

    1 tydzień temu

    Warszawa, Mazovia, Polska Indero (formerly Innovaderm) Pełny etat

    The Senior Regulatory Affairs Specialist will provide leadership for assigned projects regarding all regulatory activities that lead to startup of clinical trials and will oversee global/multinational complex large clinical trial submissions.This role will be responsible for sponsor-facing regulatory leadership and management of regulatory deliverables...

  • Regulatory Affairs Specialist

    1 tydzień temu

    Warszawa, Mazovia, Polska USP Zdrowie Pełny etat

    Twój zakres obowiązków:Utrzymywanie przydzielonych pozwoleń na produkty lecznicze (zmiany porejestracyjne) w ramach projektu dotyczącego zmiany miejsca wytwarzania produktów leczniczych znajdujących się w portfolio organizacji;Identyfikacja ryzyk rejestracyjnych wynikających ze zmieniającego się środowiska regulacyjnego, sytuacji wytwórczej...

  • Regulatory Affairs Specialist

    1 tydzień temu

    Warszawa, Mazovia, Polska Merck Sp.z.o.o. Pełny etat

    This role can be done hybrid: 3 days per week from office in Warsaw.Your role:Ready to join our Polish affiliate? This is an exceptional opportunity for a dynamic Regulatory Affairs (RA) Specialist to drive the local life cycle management for our product portfolio. This pivotal role acts as the RA expert in Poland, leading all critical regulatory activity....

  • Regulatory Affairs Senior Specialist

    1 tydzień temu

    Warszawa, Mazovia, Polska Ant Talent Pełny etat

    We are recruiting for a Regulatory Affairs Senior Specialist – Publishing to join a growing Regulatory Publishing team at an international Contract Research Organization.​Our client is an established CRO with years of experience and expertise in clinical research. Their Regulatory Affairs team offers comprehensive regulatory solutions to the biotech and...

  • Regulatory Affairs Specialist-POLAND

    2 tygodni temu

    Warszawa, Mazovia, Polska Indero Pełny etat

    Due to ongoing global expansion, Indero is looking to hire a Regulatory Affairs Specialist. In this position, you will be responsible for preparation and submission of part I and/or part II following EU CTR and other applications created within or outside of the company to ensure documentation comply with applicable regulations and guidelines and contractual...

  • Regulatory Affairs Specialist-POLAND

    1 tydzień temu

    Warszawa, Mazovia, Polska Indero (formerly Innovaderm) Pełny etat

    Due to ongoing global expansion, Indero is looking to hire a Regulatory Affairs Specialist. In this position, you will be responsible for preparation and submission of part I and/or part II following EU CTR and other applications created within or outside of the company to ensure documentation comply with applicable regulations and guidelines and contractual...

  • Regulatory Affairs Specialist

    4 dni temu

    Warszawa, Mazovia, Polska LSI Corporation Pełny etat

    Arxada is a global leader in innovative solutions that protect our world. Our groundbreaking technologies, in-depth regulatory know-how, manufacturing and process development help our customers to safeguard nutrition, health and infrastructure efficiently through chemistry and biotechnology that enhance sustainability. We offer a broad portfolio of...

  • Regulatory Affairs Manager

    2 tygodni temu

    Warszawa, Mazovia, Polska IQVIA Pełny etat 185 300 zł - 344 300 zł

    IQVIA is The Human Data Science Company. We use data, technology, analytics and human ingenuity to help healthcare clients deliver better solutions for patients and drive healthcare forward.Why this role, why IQVIA?Join our Regulatory Affairs and Drug Development Solutions organization, where technology enabled regulatory services reduce time, cost, and risk...

  • Regulatory Affairs

    2 tygodni temu

    Warszawa, Mazovia, Polska Convatec Pełny etat

    About ConvatecPioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our...