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 https://www.jnj.com

QUALIFICATIONS:

Experience and skills:

Education

• University/bachelor’s degree and 6 years of related professional experience.
• Masters/PharmD/PhD in combination with 4 years of relevant/related professional experience.

Required:

• 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 collaborators 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:

• May require up to 5% travel, domestic and international.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to follow local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

• 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 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.