Manager Regulatory Affairs Submissions

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 Product Submissions and Registration

Job Category : Professional

All Job Posting Locations :

Warsaw, Masovian, Poland

Job Description :

Manager, Submissions Management, Clinical Trial Applications

Johnson & Johnson is recruiting for a Manager RA Submissions. This hybrid work position will be located in Warsaw, PL. The position will manage Clinical Trial Applications as a member of the Next Generation Submissions (NGS) organization.

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

Key Responsibilities :

• Be responsible for the submission, operational management, and delivery of regulatory submissions at a compound level to support global development and registration, primarily focused on EUCTR Clinical Trial Applications (CTAs).
• Create and handle dossier plans / submission packages in line with regulatory strategy, seeking input from regulatory therapeutic areas, functional area representatives, and vital collaborators, while providing guidance to project team members
• Contribute to decisions that have an impact on the quality and timeliness of moderate to sophisticated Health Authority submissions
• Make decisions on submission operational strategies for the best project management approach within process / timeline / resource constraints.
• Lead Submission Team meetings to coordinate the preparation and maintenance of regulatory submissions and filings.
• Take a leadership role for the monitoring and efficiency of the submission process and initiate changes within the scope of decision-making authority to minimize inefficiencies and ensure / improve quality.
• Cultivate effective relationships, maintaining open communication with key partners to ensure priority conflicts, resource issues, and deviations from the plan are identified and resolved.
• Develop departmental work practices, process enhancements / improvements, and associated training materials
• May be responsible for performance and development of direct reports.

Qualifications - External

Qualifications, Experience and Skills :

Preferred

Other