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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 https://https://www.jnj.com/.
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
Qualifications, Experience and Skills:
University/bachelor's degree and 6 years of related professional experience, or
Masters/PharmD/PhD in combination with 4 years of relevant/related professional experience
In-depth understanding of drug development process
Ability to demonstrate in-depth knowledge of regulatory submissions, filings, and processes
Ability to work and lead in a matrix environment
Proven ability to build positive relationships and influence stakeholders across an organization
Proficiency in relevant submission-related Health Authority and Industry regulations and guidelines
Proficient use of Regulatory Information Systems
Fluency in English; other languages may be required depending on assignment.
Validated project or submission management capabilities
Previous experience leading Submission Team meetings to coordinate the preparation and maintenance of submissions and filings
Preferred
At least 5 years of Regulatory Affairs experience
Experience associated with leading EUCTR Clinical Trial Applications
Other