Regulatory Affairs Specialist at Merck Serono SA

Warszawa, Pomeranian Voivodeship, Poland -

Full Time

Start Date

Immediate

Expiry Date

10 May, 26

Salary

0.0

Posted On

09 Feb, 26

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, Product Registration, Artwork Approval, Health Authorities Interaction, Cross-Functional Alignment, Time Management, Strategic Activities Execution

Industry

Pharmaceutical Manufacturing

Description

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 pharmacist or medicine 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.

Responsibilities

The Regulatory Affairs Specialist will lead local life cycle management for the product portfolio, maintaining Marketing Authorizations and managing in-country submissions. This role also involves serving as the key contact for Health Authorities and overseeing the review and approval of promotional materials.