manager regulatory affairs
6 dni temu
If you have relevant experience and would like to participate in the process, apply for this role.
manager regulatory affairs (established products), EMEA
Nr ref.: 417/1/2025/IP/259316/jobs.pl Warszawa (mazowieckie)
What we offer
- annual performance-based bonus
- opportunity to work with a leader in the pharmaceutical industry
- a tangible impact on regulatory processes and the development of innovative products
- hybrid work model (office in Warsaw)
- company car
- additional leave benefits (e.g., bereavement leave)
- comprehensive medical care and life insurance
- employer-sponsored retirement plan
Your tasks
- Regulatory Strategy & Compliance – Oversee regulatory activities, ensuring all filings align with the global regulatory strategy and post-approval requirements
- Lifecycle Management – Optimize regulatory strategies for established products as new data becomes available and reassess global strategies as needed
- Regulatory Submissions – Prepare, review, and manage IND, NDA, CTA, and CTD dossiers, as well as lifecycle submissions (e.g., PSURs, PADERs)
- Cross-Functional Collaboration – Represent regulatory affairs in multi-disciplinary teams, providing expertise and strategic input
- Health Authority Interactions – Support FDA and global agency communications, including labeling submissions, safety reporting, and audit preparations
What we expect
- a minimum of a Bachelor's degree is required in a relevant health-related scientific discipline
- an advanced degree (MS, MD, PhD or PharmD) is preferred
- experience in regulatory affairs and significant industry experience is preferred
- knowledge of drug development and the regulatory submission and approval process is essential
- excellent verbal oral and written communication skills are required as well as the ability to work successfully within a collaborative, cross-functional team environment
- additional skills required include the ability to prioritize effectively assignments for multiple products and projects;
Employment agency entry number 47
this job offer is intended for people over 18 years of age
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