Regulatory Affairs Specialist in Poland (all genders) at Merck Healthcare Vietnam Ltd., Vietnam

Warszawa, Pomeranian Voivodeship, Poland -

Full Time

Start Date

Immediate

Expiry Date

31 Jan, 26

Salary

0.0

Posted On

02 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Project Management, Stakeholder Management, Communication Skills, Regulatory Compliance, Dossier Review, Submission Management, Quality Control, Attention to Detail, Proactive Communication, English Proficiency, Polish Proficiency

Industry

Pharmaceutical Manufacturing

Description

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. This role can be done in a hybrid working model 3 days from Warsaw office. 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. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

Responsibilities

Drive local life cycle management for the product portfolio and maintain Marketing Authorizations. Act as the RA expert in Poland, leading critical regulatory activities and serving as the key point of contact for Health Authorities.