Manager, Regulatory Cta Submissions Management

Vor 5 Tagen


Allschwil, Schweiz Johnson & Johnson Family of Companies Vollzeit

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



  • Allschwil, Schweiz Johnson & Johnson Family of Companies Vollzeit

    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...


  • Allschwil, Schweiz Idorsia Pharmaceuticals Ltd. Vollzeit

    **About Idorsia Pharmaceuticals Ltd** Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we want to develop Idorsia into one of Europe’s leading biopharmaceutical companies, with a strong scientific core. Headquartered in Switzerland - a European biotech hub -...


  • Allschwil, Schweiz Johnson & Johnson Vollzeit

    **Manager Medical Writing**: Position Summary: - Able to write and coordinate complex documents within and across therapeutic areas (TAs) independently. - Able to function as a lead writer on any compound with general supervision. - Leads discussions in or leads process working groups. - Actively participates in setting functional tactics/strategy. -...


  • Allschwil, Schweiz Basilea Pharmaceutica Ltd Vollzeit

    Analytical Development & Quality Testing ManagerPermanent employee,Full-time· AllschwilWe are looking for.......a highly motivated Analytical Development & Quality Testing Managerfor our Technical Operations department.Actively contribute to CMC and project operation team and collaborate with multifunctional teams within Basilea and externally with...


  • Allschwil, Schweiz Basilea Pharmaceutica International Vollzeit

    We are looking for.......a highly motivated Analytical Development & Quality Testing Manager for our Technical Operations department.Your tasksActively contribute to CMC and project operation team and collaborate with multifunctional teams within Basilea and externally with partners.Oversee, monitor and drive outsourced analytical studies for chosen Basilea...


  • Allschwil, Schweiz Johnson & Johnson Vollzeit

    Job Description - Associate Director, Document Publishing (2406222997W) Associate Director, Document Publishing - 2406222997W Description Johnson & Johnson Innovative Medicine is recruiting for an Associate Director Document Publishing. This position can be located in the US (Spring House, PA; Horsham, PA; Titusville, NJ; and Raritan, NJ); Beerse, Belgium;...


  • Allschwil, Schweiz Johnson & Johnson Vollzeit

    **Clinical Programming: Oncology Head, Clinical Programming** At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease and the development of best-in-industry data science capabilities is critical to our ambition to be most innovative healthcare company. Within our Integrated Data Analytics & Reporting...


  • Allschwil, Schweiz Basilea Pharmaceutica International Vollzeit

    **We are looking for...**: ....a highly motivated Procurement Manager Supply Chain & Technical Operation for our Finance department. **Your tasks**: - Manage sourcing activities with a focus on the category Supply Chain ranging from development to commercial pharmaceutical products - Responsible for Strategic Procurement and Vendor Relationship...


  • Allschwil, Schweiz Hobson Prior Vollzeit

    Get AI-powered advice on this job and more exclusive features.Direct message the job poster from Hobson PriorPrincipal Recruitment Consultant // Head Hunter – Supporting Candidates and Clients in Quality and Engineering within Pharmaceuticals, Biotech and…Job Description:Hobson Prior is seeking a Quality Assurance Manager to join a dynamic team in...


  • Allschwil, Schweiz Basilea Pharmaceutica International Vollzeit

    **We are looking for...**: ....a highly motivated **Pharmaceutical Development & Manufacturing Manager** for our **Technical Operations** department. **Your tasks**: - Responsible for the pharmaceutical development and manufacturing of drug products for clinical and commercial supplies in compliance with cGMP and regulatory requirements - Oversee, manage...


  • Allschwil, Schweiz ThermoFisher Vollzeit

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionKey Responsibilities:Independently manages a client portfolio of moderate to strategic or complex projectsLeads the delivery of all technical and service aspects of projects and studies for clients, looking for opportunities to create better efficiencies or creative problem solving...


  • Allschwil, Schweiz Thermo Fisher Scientific Vollzeit

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionYour Role in that Mission:Join our Distributed Client Services team and be part of a united effort: Empowered to Take Initiative, Foster Connections and Deliver Results for our customers and their patients.The Distribution Project Manager independently manages a portfolio of moderate...


  • Allschwil, Schweiz Basilea Pharmaceutica Ltd Vollzeit

    ....a highly motivated Investor Relations Manager for our Finance department. Communicate with current and potential shareholders, analysts and other stakeholders about the company’s financial performance, strategy and opportunities as well as about the development pipelineRespond to investor and analyst inquiries; ensure alignment within the Finance...


  • Allschwil, Schweiz Thermo Fisher Scientific Vollzeit

    Group/ Division: Pharma Services Group/ Clinical Trial Division- Career Track: Management- Position Location: EMEA Remote*** - The Senior Quality Manager, Comparator is responsible for the GxP compliance and quality of the supply chain management of procurement and distribution of comparator medications.- Responsibilities include leadership of a team of...


  • Allschwil, Schweiz Thermo Fisher Scientific Vollzeit

    **Group/ Division: Pharma Services Group/ Clinical Trial Division**: **Career Track: Management**: **Position Location: EMEA Remote**: **Position Summary**: **The Senior Quality Manager, Comparator is responsible for the GxP compliance and quality of the supply chain management of procurement and distribution of comparator medications.**: **Responsibilities...


  • Allschwil, Schweiz Johnson & Johnson Vollzeit

    **Director, Trial Management** Johnson & Johnson Innovative Medicine is recruiting for a **Director, Trial Management **( **Medical Affairs Delivery Unit **) to be located in the US (Horsham, PA; La Jolla, CA; Raritan, NJ; Spring House, PA; Titusville, NJ), Europe (Basel, CH; Beerse BE; High Wycombe, UK; Cork, IE; Leiden, NL), or Asia (China, Japan...


  • Allschwil, Schweiz Basilea Pharmaceutica Vollzeit

    We are looking for.......a highly motivated Investor Relations Manager for our Finance department.Your tasksCommunicate with current and potential shareholders, analysts and other stakeholders about the company’s financial performance, strategy and opportunities as well as about the development pipelineRespond to investor and analyst inquiries; ensure...


  • Allschwil, Schweiz Basilea Pharmaceutica International Vollzeit

    We are looking for... ....a highly motivated Investor Relations Manager for our Finance department. Your tasks Communicate with current and potential shareholders, analysts and other stakeholders about the company’s financial performance, strategy and opportunities as well as about the development pipeline Respond to investor and analyst...


  • Allschwil, Schweiz Johnson & Johnson Family of Companies Vollzeit

    Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for an **Associate Director Data Acquisition Leader** to join our **Data Acquisition & Coding (DAC)** team within **Integrated Data Analysis and Reporting (IDAR) Data Management**. This position is to be located in Springhouse, PA; Chesterbrook,...


  • Allschwil, Schweiz Johnson & Johnson Vollzeit

    **Director of Flex Resource Management MA** Johnson & Johnson Innovative Medicine is recruiting for a **Director of Flex Resource Management MA **to be located in the US (Horsham, PA; La Jolla, CA; Raritan, NJ; Spring House, PA; Titusville, NJ), Europe (Basel, CH; Beerse BE; High Wycombe, UK; Cork, IE; Leiden, NL), or Asia (China, Japan Singapore). The...