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Manager, Regulatory Affairs Established Products, Warsaw

Client: Johnson and Johnson

Location: Warsaw, Poland

Job Category: Other

EU work permit required: Yes

Job Reference: fd2a056df9a7

Job Views: 3

Posted: 02.05.2025

Expiry Date: 16.06.2025

Job Description:

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function: Regulatory Affairs

Group Job Sub Function: Regulatory Affairs

All Job Posting Locations: Warsaw, Masovian, Poland

Key Responsibilities:

• The Regulatory Scientist provides support to the Global Regulatory Leader (GRL) for regulatory activities in the assigned portfolio, including ensuring that content of regulatory filings support our global regulatory strategy and product strategy position.
• Participate in global regulatory team meetings as appropriate.
• Advise the regulatory team on applicable regulatory requirements and project-specific regulatory issues.
• Support late lifecycle activities, divestment, and delisting.
• Develop an understanding of the global regulatory environment, competitor intelligence, and the Established Products portfolio.
• Liaise with Regulatory Agencies and Local Operating Companies, acting as a backup contact as needed.
• Draft cover letters for Regulatory Agency communication.
• Assist in the preparation of meetings with Regulatory Agencies.
• Liaise with LOCs, ensure timely responses to queries, and maintain consistency with regulatory strategy.
• Assist in process development related to regulatory submissions.
• Review clinical trial plans and protocols for regulatory compliance.
• Support health authority submissions and provide guidance on required documents and submission strategies.
• Ensure timely availability of submission documents and review content for compliance.
• Participate in cross-functional team meetings as appropriate.
• Review submission documents and ensure compliance with regulatory requirements.
• Ensure country-specific submission packages are prepared and available to LOCs in accordance with plans.

Qualifications:

• University/Bachelor’s degree; generally 6+ years of experience, with 5+ years in relevant industry preferred; advanced degree or equivalent experience preferred.
• Knowledge of regulatory requirements related to submissions and registration processes.
• Understanding of dossier components and lifecycle submission requirements.
• Proficiency in Microsoft programs and electronic management systems; experience with AI is a plus.
• Regulatory intelligence, including understanding of the competitive landscape, health authority views, and therapeutic area issues.
• Up-to-date knowledge of approvals in relevant therapeutic areas.
• Basic medical/scientific understanding in a clinical area.
• Ability to provide strategic regulatory guidance and interpret local regulations.
• Knowledge of health authority operations and organizational structures.

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