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Manager Regulatory Affairs (Established Products), EMEA, Warsaw

Client:

Location: Warsaw, Poland

Job Category: Other

EU work permit required: Yes

Job Reference: 96cb8c4b66c3

Job Views: 4

Posted: 10.02.2025

Expiry Date: 27.03.2025

Job Description:

For our Client, one of the biggest Pharmaceutical Companies worldwide, we are looking for a Regulatory Affairs Manager EMEA, who will provide regulatory support to the Portfolio Leader for a portfolio of marketed oncology and internal medicine drug products which are supported by the Established Products team.

If you have relevant experience and would like to participate in the process, apply for this role.

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

Key Responsibilities:

• 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 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.

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