Manager, Regulatory Cta Submissions Management
Vor 5 Tagen
Janssen Research & Development, LLC., is recruiting for a Manager, Regulatory CTA Submissions Management, in Raritan, NJ; Titusville, NJ; Spring House, PA; Horsham, PA; Radnor, PA; Malvern, PA, La Jolla, CA; San Francisco, CA; Los Angeles, CA; Beerse, Belgium; Leiden, The Netherlands; Allschwil, Switzerland, or High Wycombe, England.
The position will manage Clinical Trial Applications as part of the Oncology therapeutic area team within Regulatory Submissions Management and Operations.
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 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**
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:
- In-depth understanding of drug development process
- Ability to demonstrate knowledge of regulatory submissions and filings
- 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 Clinical Trial Applications
Other:
- May require up to 5% travel, domestic and international.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
**Primary Location**
United States-New Jersey-Raritan-920 US Highway 202
**Other Locations**
North America-United States-Pennsylvania-Radnor, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-Pennsylvania-Malvern, North America-United States-Pennsylvania-Spring House, North America-United States-California-Los Angeles, North America-United States-California-San Francisco, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Horsham, North America-United States-California-La Jolla, Europe/Middle East/Africa-Switzerland-Allschwil
**Organization**
Janssen Research & Development, LLC (6084)
**Job Function**
Regulatory Affairs
**Requisition ID**
2206015895W
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