Lead Associate, Regulatory Submission Management.

Job content

Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting for a Lead Associate, Regulatory Submission Managementwith experience in managing major global marketing application submissions to be part of the Regulatory Submissions Management and Operations team within Global Regulatory Affairs (GRA). This position will support the Oncology therapeutic area and may be located in Raritan, NJ; Titusville, NJ; Cherry Hill, NJ; Spring House, PA; Horsham, PA; Radnor, PA; Malvern, PA, La Jolla, CA; San Francisco, CA; Los Angeles, CA; Beerse, Belgium; Leiden, Holland; Allschwil, Switzerland, or High Wycombe, England. Remote flexibility may be considered.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolic diseases, and pulmonary hypertension. Please visit http://www.JanssenRnD.com for more information.

The Lead Associate, Regulatory Submission Management Will

Be responsible for the submission operational management and delivery of regulatory submissions across multiple products to support the development, registration, and compliance in the assigned countries/ region

• Create and manage Dossier Plans/Submission Packages in line with regulatory strategy. Provide guidance to therapeutic and functional area team representatives, regional and/or country representatives and other key stakeholders.
• Ensure timely delivery of high-quality dossiers (working with partners to manage content, format, timelines) while maintaining appropriate records and oversight in applicable systems and tools
• Lead Submission Team meetings to oversee the preparation and maintenance of regulatory submissions and filings for the assigned products and countries.
• Monitor the effectiveness of the dossier process and identify improvement opportunities.
• Lead and/or participate in special projects and process improvement initiatives; contribute to country-specific regulatory submission intelligence gathering and maintenance
• Where appropriate, provide component- level publishing support for regulatory-owned deliverables in PDF format to ensure dossier components conform to submission standards.
• Utilize current electronic document management systems/tools and/or publishing technologies to assemble and publish dossiers according to regulatory requirements for paper and electronic submissions, with a high degree of independence.
• Apply appropriate regulatory submission standards, requirements, processes, and policies to comply with applicable health agency requirements.
• Cultivate ongoing effective relationships within GRA as well as cross-functionally. Work with partners to communicate and resolve issues/ concerns with submission timelines.
  
  

Requirements

Qualifications

• A minimum of a Bachelor’s Degree or undergraduate degree in combination with a minimum of 6 years of relevant/related professional experience OR a Masters/PharmD/PhD in combination with a minimum of 1 years of relevant/related professional experience is required
• A minimum of 5 years of Regulatory Affairs experience is preferred
• Experience associated with managing global Marketing Applications (e.g., NDA/BLA/MAA/NDS), including knowledge of submission related Health Authority (HA) and industry submission dossier regulations and guidelines, is required
• In-depth understanding of drug development process is required
• Demonstrated project or submission management is highly preferred
• Previous experience leading Submission Team meetings to coordinate the preparation and maintenance of regulatory submissions and filings is highly preferred
• A demonstrated 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
• A demonstrated ability or direct experience to use Regulatory Information systems required
• This position may require up to 5% domestic and international travel
  
  

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

Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-California-La Jolla, Europe/Middle East/Africa-Switzerland-Allschwil, Netherlands-South Holland-Leiden, Europe/Middle East/Africa-United Kingdom-England, North America-United States-California-Los Angeles, North America-United States-California-San Francisco, North America-United States-New Jersey-Cherry Hill, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Horsham, North America-United States-Pennsylvania-Malvern, North America-United States-Pennsylvania-Radnor, North America-United States-Pennsylvania-Spring House

Organization

Janssen Research & Development, LLC (6084)

Job Function

Regulatory Affairs

Requisition ID

2105957217W