Regulatory Submissions Associate (CTA)

Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting for an :

Associate or Senior Associate, Submission Management

with Clinical Trial Application management experience to be part of the Pulmonary Hypertension (PH) therapeutic area team within Regulatory Submissions Management and Operations.

This position is located in Allschwil, Switzerland.

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/ Senior Associate, Submission Management will:

• Be responsible for the management and delivery of regulatory submissions to global health authorities required to support the development and registration of products, primarily focused on Clinical Trial Applications (CTAs).

• Establishing Dossier Plans for the assigned submission types that reflect inputs from functional area representatives and key stakeholders, meeting regularly with submission stakeholders and cross-functional representatives to identify and resolve issues and to assess quality and delivery of Dossier Plans, quality of deliverables and timelines against established KPIs.
• Monitoring the effectiveness of appropriate submission processes with responsibility for initiating changes within the scope of decision-making authority to minimize inefficiencies and ensure quality.
• Ensuring dispatch/distribution in compliance with due dates to Health Authorities and/or Local Operating Companies, as applicable, tracking submission events/activities in appropriate systems/tools.
• Support development of departmental work practices, process enhancements, and associated training materials.
• Represent department on Janssen initiatives where appropriate.
• Develop/maintain associated process tools and relevant training documentation.

Qualifications

• A minimum of a University/Bachelor’s Degree or equivalent degree required
• For Senior Associate level: 4 to 6 years of relevant/related professional experience required or Masters/Pharm D or PhD with 0-2 years’ experience.
• Experience associated with managing or publishing of global regulatory submissions, in particular CTAs, is highly preferred
• Therapeutic area and product knowledge is highly preferred
• Understanding of drug development process is preferred
• Project or submission management capabilities is highly preferred
• Effective interpersonal, teamwork, and communication skills required
• Ability to work or lead in a matrix environment required
• Ability to build productive relationships across an organization required
• Knowledge of relevant submission-related Health Authority and Industry regulations and guidelines is required - particularly with regards to Clinical Trial Applications and GCP
• Problem solving capability, including trouble shooting and adaptability required
• Fluency in English is required; proficiency in other languages may be an advantage
• This role will be located in Allschwil, Switzerland

If you are interested in making an impact by working in a culture of innovation, trust and teamwork, we welcome your online application by clicking here.

Primary Location
Switzerland-Allschwil– Organization
Actelion Pharmaceuticals Ltd (Swiss Confederation) (8542)
Job Function
Submissions
Requisition ID
1905721384W