EMEA Regulatory Affairs Manager - Strategic Submissions

Bausch Health

Warszawa

Hybrid

PLN 180,000 - 240,000

Full time

2 days ago

Be an early applicant

A complete application in a minute

Tailored resume and cover letter, ready to send.

Get past ATS filters

Benefits offered by this job

International projects

Regional regulatory hub

Strategic regulatory initiatives

Job summary

Bausch Health Poland is seeking an experienced Regulatory Affairs Manager to lead regulatory submissions, lifecycle management, and strategic projects across the EMEA region. The role blends regulatory expertise with cross-functional collaboration in a hybrid model across Warsaw, Rzeszów, and Jelenia Góra.

You will interact with health authorities, manage CTD dossiers, and guide regional projects and due diligence initiatives.

Qualifications

Minimum 8 years of Regulatory Affairs experience within the pharmaceutical industry.
Solid knowledge of EU regulatory procedures (DCP, MRP, CP, and National Procedures).
Proven experience in product registrations and lifecycle management.
Excellent command of English, both written and spoken.
Degree in Pharmacy, Medicine, Biology, Life Sciences, or a related field.

Responsibilities

Manage regulatory submissions and prepare CTD dossiers, including communication with Health Authorities and eCTD preparation.
Lead lifecycle management activities (variations, renewals, and maintenance) for a portfolio of medicinal products.
Participate in regional projects and market expansion initiatives, including Due Diligence activities.
Support regulatory strategy development and collaborate with cross-functional teams, including Medical, QA, and CMC.
Provide expert Regulatory Affairs guidance and support to internal stakeholders.