Manager, Submission Management (1 of 2)
Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting for a Manager, Submission Management with experience in managing Major Global submissions to be part of the Cardio Vascular and Metabolism (CVM) or Oncology therapeutic area team within Regulatory Submissions Management and Operations. This position may be located 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; or High Wycombe, England.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visithttp://www.JanssenRnD.comfor more information.
Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information.
The Manager, Submission Management will:
- Be responsible for the submission operational management and delivery of regulatory submissions required at a compound level to support the development, registration, and compliance of products.
- Coordinates the preparation and maintenance of regulatory submissions and filings. Leads Submission Team meetings, as applicable.
- Creates and manages the Dossier Plan(s)/Submission Packages in line with regulatory strategy. Seeks input from regulatory therapeutic areas, functional area representatives, and key stakeholders. Provides guidance to project team members.
- Takes a leadership role for the monitoring and effectiveness of the submission process and initiates changes within the scope of decision-making authority to minimize inefficiencies and ensure / improve quality.
- Applies appropriate regulatory submission standards, requirements, processes, and policies to comply with applicable health agency requirements.
- Cultivates ongoing effective relationships across GRA as well as cross-functionally. Maintains open communications with key partners to ensure priority conflicts, resource issues, and deviations from the plan are identified and resolved.
- May be responsible for performance oversight, development, and accountability of direct reports.
- Develops departmental work practices, process enhancements / improvements, and associated training materials.
- A minimum of a Bachelor's Degree required
- A minimum of 6-8 years of relevant/related professional experience required with Bachelor's Degree. Masters/PharmD/PhD with 4-6 years' experience is preferred
- A minimum of 5 years of Regulatory Affairs experience preferred
- Experience associated with managing global regulatory submissions, in particular Marketing Applications (NDA/BLA/MAA/NDS), is highly preferred
- Therapeutic area and product knowledge is preferred
- In-depth understanding of drug development process required
- Demonstrated project or submission management capabilities is highly preferred
- Demonstrated effective interpersonal, teamwork, and communication skills required
- Ability to exercise solid judgment and communicate effectively with varied levels of the organization required
- Ability to work or lead in a matrix environment required
- Demonstrated ability to build productive relationships and influence stakeholders across an organization required
- Knowledge of relevant submission-related Health Authority and Industry regulations and guidelines is required
- Problem solving capability, including trouble shooting and adaptability required
- Ability to use Regulatory Information systems required
- This role will be located 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; or High Wycombe, England and 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.
United States-New Jersey-Raritan
Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-Pennsylvania-Horsham, North America-United States-California-Los Angeles, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring House, North America-United States-California-La Jolla, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-Pennsylvania-Radnor, North America-United States-California-San Francisco, North America-United States-Pennsylvania-Malvern
Janssen Research & Development, LLC. (6084)
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