Associate, Submissions Management

Janssen Research & Development, LLC, a Johnson & Johnson company, is recruiting for an Associate, Submissions Management to join our Regulatory Submissions Management and Operations team within Global Regulatory Affairs (GRA)!

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

Are you interested in joining a team that is positively impacting patients’ lives by ensuring high quality submissions in our pharmaceutical products? Apply today for this exciting opportunity!

The Submissions Management Associate is responsible for collaborating with colleagues to ensure compliance with regulatory agency regulations and interpretation. They coordinate and compile dossier plans/submission packages, arrange review and approval of submission packages, and may publish/dispatch. The Associate may be responsible for the management and delivery of Clinical Trial Authorization (CTA) Applications, Original Marketing Authorization Applications, as well as Lifecycle Submissions. Updating records information management systems is also a responsibility of the Associate. Special projects may be assigned and reviewed periodically.

Key Responsibilities:

• Assist in the preparation of dossier plans/submission packages for products in line with regulatory strategy.
• Interact with regulatory therapeutic areas, functional area representatives, facilitating meetings as needed.
• Support development of departmental work practices, process improvements, and associated training materials.
• May create and/or sign specific submission documents or publish dossiers according to regulatory requirements for paper and electronic submissions.

Qualifications

Education:

• Minimum of a Bachelor’s or equivalent degree required; focused degree preferred in Science or Technical subject area

Experience and Skills:

Required:

• Minimum of two (2) years of relevant work experience
• Experience or familiarity with planning and publishing Clinical Trial Authorization (CTA) Applications, Original Marketing Authorization Applications, and/or associated Lifecycle Submissions
• Excellent interpersonal, teamwork, and communication skills, and the demonstrated ability to work or lead in a matrix environment
• Experience facilitating small meetings

Preferred:

• Experience in a health regulated industry
• Regulatory Affairs experience
• Solid understanding of the drug development process
• Experience or familiarity with Regulatory Information Systems planning tools
• Demonstrated project or submission management capabilities
• Knowledge of submission-related Health Authority (HA) and industry regulations

Other:

• Requires fluency in English (speak/read/write)
• Requires up to 5% travel domestic and international

This position may be located in: United States (Cherry Hill, NJ; Raritan, NJ; Titusville, NJ; Spring House, PA; Horsham, PA; Radnor, PA; Malvern, PA, La Jolla, CA; San Francisco, CA; Los Angeles, CA; Irvine, CA), Beerse, Belgium; Leiden, The Netherlands; Allschwil, Switzerland; or High Wycombe, England. Remote flexibility may be considered.

For individuals hired in the United States the base pay range for this position is $56,000 to $78,000 USD.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

For individuals hired in the United States, they may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long-term incentive, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below. For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location
United States-New Jersey-Raritan-920 US Highway 202
Other Locations
North America-United States, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-Switzerland
Organization
Janssen Research & Development, LLC (6084)
Job Function
Regulatory Affairs
Requisition ID
2105950889W