Manager, Regulatory Professional, Oncology (2 positions) Job in Los Angeles, California US
Johnson Johnson Pharmaceutical Research Development, LLC, a member of Johnson Johnson's Family of Companies, is recruiting for 2 Regulatory Professional, Managers to be located in Los Angeles, CA; Spring House, PA, Titusville, NJ, or Raritan, NJ campuses, however Los Angeles, CA is the preferred location.
Johnson Johnson Pharmaceutical Research Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and developmen t areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
The Regulatory Professional, Manager provides support to the Regulatory Leader (RL) and/or Global Regulatory Leader (GRL) for regulatory activities for compounds in development and/or marketed products in the assigned portfolio within the therapeutic areas. Under the direction of the RL/GRL, key responsibilities include the following: preparing or contributing to IND, CTA, NDA and eCTD dossier filings and related submissions including preparation of meeting packages and responses to Health Authorities (HA) inquiries as delegated by the RL or GRL. This position requires knowledge of local regulations and submission requirements for lifecycle submissions, e.g., protocols and protocol amendments, informational amendments, annual reports, IND Safety Reports, PADERs and PSURs. This individual is responsible for the critical review of submission documents to ensure compliance with regulatory requirements. May provide regulatory input for and appropriate follow-up to inspections, audits and product complaints. May serve as the Regulatory representative on specific multi-discipline teams, may be responsible to organize and chair meetings.
The Regulatory Professional, Manager provides regional input to the global regulatory strategy. Helps develop strategy by researching regulatory and medical information in preparing submissions to regional HA. Assists with reviewing and interpreting related product SBAs, EPARs and current HA guidance's and Advisory Committee meetings. Works with the RL/GRL to understand the competitive landscape, e.g., views of HA, regulatory precedents, labeling differences and therapeutic area issues. Keeps abreast of current and pending approvals in specific therapeutic areas and is knowledgeable of laws, guidances and requirements related to those areas. May provide input to Standard Operating Procedure documents to ensure accuracy and compliance.
Qualifications
A Bachelor's degree and a minimum of 8 years of overall experience, or an advanced degree and a minimum of 6 years of overall experience is required. A minimum of 5 years of relevant pharmaceutical industry experience is required. Regulatory Affairs experience is preferred. An understanding of the drug product lifecycle from discovery to marketing is required. A basic medical/scientific understanding of clinical trials is preferred. Knowledge of HA organizational structure and HA processes for reviewing submissions is required. Experience with companion diagnostics, combination products and/or biomarker development experience within oncology is preferred. Strong knowledge of FDA and ICH Regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is required. Excellent oral and written communication skills are required. The ability to work successfully within a collaborative team environment and as an individual contributor and decision maker within a cross-functional organization is required. The ability to effectively prioritize assignments for multiple products and projects simultaneously is required. Limited travel (less than 10%) may be required. The preferred location for this position is Los Angeles, CA, however this position can also be located in Spring House, PA, Titusville, NJ, or Raritan, NJ.
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