Senior Associate, Regulatory Submissions Management

工作内容

Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting for a Senior Associate, Regulatory Submission Management with Clinical Trial Application management experience to join the Regulatory Submissions Management and Operations organization. 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; High Wycombe, England or Allschwil, Switzerland. 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 visit http://www.JanssenRnD.com for 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 Senior Associate, Regulatory 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, with primary focus on Clinical Trial Applications (CTAs). Be responsible for establishing Dossier Plans for the assigned submission types (CTA as well as registration submissions, as applicable) 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 dispatch / distribution dates as agreed with the cross-functional team. In the Regulatory Clinical Trial Application submission management role, be responsible for overseeing relevant CTA submissions and notifications over the entire life cycle of the clinical trial, from initial CTA to completion of study close-out activities, as well as interactions with Health Authorities. Central point of contact for the cross-functional clinical trial team and primary contact point for regulatory authorities for communications where also acting as Applicant. Coordination with functional area owners and local points of contact to assemble regional/local submission package in line with agreed Dossier Plan. Maintain open, timely and effective communications with cross-functional clinical trial team, to ensure timely delivery of dossier components and/or complete dossier for submission. Ensuring relevant submission process(es) are applied to all assigned submissions, including appropriate quality controls to deliver high quality regulatory submissions that conform to regional and country specific regulatory requirements as appropriate. Support development of departmental work practices, process enhancements, special projects, and associated training materials where appropriate. Represent department on Janssen initiatives where appropriate. Support compliance needs as appropriate. Qualifications University/ Bachelor’s Degree or equivalent and a minimum of 4 years of pharmaceutical industry or relevant/related professional experience required, or a Masters/Pharm D. or PhD and previous pharmaceutical industry or related professional experience required Regulatory Affairs experience highly preferred Awareness of relevant submission-related Health Authority and Industry regulations and guidelines, with a focus on clinical trials (e.g. GCP, EU Clinical Trial Directive, EU Clinical Trial Regulation), is required Experience associated with managing global regulatory submissions is highly preferred Understanding of drug development process required Demonstrated project or submission management capabilities is highly preferred Demonstrated effective interpersonal, teamwork, and communication skills and ability to build productive relationships across an organization required Problem solving capability, including troubleshooting and adaptability required Demonstrated ability to communicate effectively at a professional level in the English language (both oral and written) are 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; High Wycombe, England; or Allschwil, Switzerland, and may require up to 5% travel, domestic and international. BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies. Primary Location Switzerland-Allschwil- Other Locations North America-United States-California-Los Angeles, North America-United States-California-La Jolla, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-Pennsylvania-Spring House, North America-United States-Pennsylvania-Radnor, North America-United States-Pennsylvania-Malvern, North America-United States-Pennsylvania-Horsham, North America-United States-California-San Francisco, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States-New Jersey-Raritan Organization Actelion Pharmaceuticals Ltd (Swiss Confederation) (8542) Job Function Regulatory Affairs Requisition ID 2105965780W