Johnson & Johnson Careers

Global DRA Submission Management Leader

Switzerland
Regulatory Affairs


Job Description

Requisition ID: ACT1800000X

Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting for an Associate Director, Submissions Management with experience in managing Major Global submissions to be part of the Actelion (Pulmonary Hypertension) team within Regulatory Submissions Management and Operations.  This position may be located in Allschwil, Switzerland (Preferred); Beerse, Belgium; Leiden, The Netherlands; or High Wycombe, United Kingdom.

 

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

 

The Associate Director, Submissions Management:

  • Manages a team of specialists in the planning and preparation and maintenance of regulatory submissions and filings. Provides guidance to project team members. Is responsible for performance oversight, development, and accountability of staff.
  • Manages and leads team in all Human Resources processes including the 5 Conversations.
  • Leads the coaching and development process for team and other colleagues.
  • Leads others and holds staff accountable to the application of appropriate regulatory submission standards, requirements, processes and policies to comply with applicable health agency requirements.
  • Analyzes and prioritizes team workload and assignments. Ensures submission events are tracked using appropriate systems/tools.
  • Directs the submission operational strategy in line with regulatory strategy as applicable.
  • 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. 
  • Applies appropriate regulatory submission standards, requirements, processes, and policies to comply with applicable health agency requirements.
  • Cultivates ongoing effective relationships across Global Regulatory Affairs 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. 
  • Takes a leadership role to ensure that all required documents are included in the dossier and that submission events/activities are tracked in appropriate systems/tools.
  • Takes a leadership role in the development of departmental work practices, process enhancements and or improvements.
  • Ensures and maintains openly, timely and effective communications with all partners and staff to ensure timely deliverables.
  • Ensures effective interactions with key partners to ensure priority conflicts, resource issues, and deviations from the plan are identified and resolved.
  • Removes obstacles as needed. Partners across Global Regulatory Affairs and functional area contributing groups as needed for assigned projects.
  • Contributes to the management of budget and resources for assigned organization and manages work to achieve budget goals.

Qualifications

  • A minimum of a Bachelor’s Degree required
  • A minimum of 8-10 years of relevant/related professional experience required with Bachelor’s Degree.  Masters/PharmD/PhD with 6+ years of experience is required
  • A minimum of 5 years of Regulatory Affairs experience is required
  • Project leadership experience is required
  • People management experience (direct reports or team) is required
  • 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 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 and skills to build productive relationships across the organization and with external stakeholders.
  • Expert project and submission management capabilities.
  • Demonstrated problem solving, trouble shooting, and adaptability.
  • Proficiency in submission related Health Authority and Industry regulations and guidelines as relevant.
  • Ability to use Regulatory Information systems required

    This role will be located in Allschwil, Switzerland (Preferred); Beerse, Belgium; Leiden, The Netherlands; or High Wycombe, United Kingdom and may require 5-10% travel, domestic and international (significantly more travel may be required if not based in Allschwil, Switzerland).

Primary Location
Switzerland---
Organization
Janssen Pharmaceuticals, Inc (6062)
Job Function
Regulatory Affairs
Requisition ID
ACT1800000X