HireDiversity

Raritan, NJ, US

Manager, Regulatory Affairs-6133121227

Description

Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a North America Regulatory Affairs Manager in the Neuroscience Therapeutic area to be located in Raritan or Titusville, New Jersey.

Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.

The Manager, Regulatory Affairs provides support to the NA Regulatory Leader (NARL) and/or Global Regulatory Leader (GRL) for regulatory activities of compounds in development and/or marketed products in the assigned portfolio within the Neuroscience therapeutic area. Under the direction of the NARL/GRL, this individual supports all regulatory activities associated with the registration and maintenance of new and approved drug products. This individual provides regulatory strategic and operational support for products by interacting with project teams, reviewing protocols, and maintaining INDs and NDAs (prepare and submit regulatory submissions including labeling supplements, safety reports, protocol amendments, annual reports, etc). This requires knowledge of FDA regulations and submission requirements for lifecycle submissions, e.g., protocols and protocol amendments, informational amendments, IND/NDA annual reports, IND/NDA Safety Reports, PADERs and PSURs. The Manager, Regulatory Affairs is responsible for the critical review of submission documents to ensure compliance with regulatory requirements. This individual may serve as the Regulatory representative on specific multi-discipline teams and may be responsible to organize and chair meetings. This individual provides US input to the global regulatory strategy and helps develop strategy by researching regulatory and medical information in preparing submissions to FDA.

The Manager, Regulatory Affairs assists with reviewing and interpreting related product SBAs and current HA guidance's and Advisory Committee meetings. This individual works with the NARL/GRL to understand the competitive landscape, e.g., views of FDA regulatory precedents, labeling differences and therapeutic area issues. This individual is responsible to keep abreast of current and pending approvals in specific therapeutic areas and is knowledgeable of laws, guidances and requirements related to those areas. The Manager, Regulatory Affairs may provide input to Standard Operating Procedure documents and processes to ensure accuracy and compliance. In addition, this individual provides guidance and support to product development teams on regulatory issues.

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Qualifications


A Bachelor's degree and a minimum of 8 years of overall pharmaceutical, medical device, or consumer industry experience is required. A degree in a scientific discipline is highly preferred. An advanced degree (MS, PharmD, PhD) is desirable. A minimum of 5 years of relevant Regulatory Affairs pharmaceutical experience is required. Regulatory drug development experience with the FDA is strongly preferred. This individual must understand the life cycle of drug products from discovery to marketing, have a basic medical/scientific understanding of clinical trials and drug development, and have knowledge of FDA organizational structure and processes for reviewing and approval of various types of regulatory submissions.

Excellent communication skills and exceptional interpersonal abilities are required. Strong knowledge of FDA and ICH regulatory requirements and guidelines is required. This individual must be able to work independently as well as in a matrix team environment. Limited domestic travel (<10%) may be required. This position can be based in Raritan (preferred) or Titusville, New Jersey.

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Primary Location:North America-United States-New Jersey-Raritan
Other Locations:North America-United States-New Jersey-Titusville
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Regulatory Affairs