HireDiversity

Spring House, PA, US

Associate Director - Regulatory CMC Dossier-6450130107

Description

Janssen Research & Development, L.L.C., a Johnson & Johnson Company, is recruiting for an Associate Director - Regulatory CMC Dossier, to be located in Springhouse, PA, Malvern, PA, Raritan, NJ or Titusville, NJ.

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.

Responsible to provide oversight in the development of technical eCTD sections to support Regulatory CMC dossier applications. Coordinates and provides technical oversight for the generation of the Quality module 3 of marketing and clinical trial submissions. Represents the department on multi-functional project development teams to support regulatory filings. Must possess scientific understanding of pharmaceutical development functions as well as knowledge of proper interpretation of applicable global regulatory guidances . Assumes personal ownership and accountability for business results and solutions; consistently delivers results; makes the customer central with minimal supervision. Often acts as a mentor.

Manages the development and technical planning and submission process for Quality related sections. Mentors junior staff in the development of dossiers. Consistently meets and sometimes exceeds the minimum competency standard to proactively sense and respond to problems and opportunities; works to reduce "cycle" time; takes action when needed. Demonstrates focus and clarity of thought under ambiguous or complex situations with minimal supervision. Authors the Module 2 Quality Summary/Module 3 textual body regulatory sections and evaluates/ensures final versions comply with regulatory requirements and fulfills Regulatory Agency expectations. Authors and finalizes the iCTD, ASEAN and other ROW major submissions, minor submissions and responses to health authorities.

Keeps abreast of pertinent regulatory guidance. Provides interpretation of relevant CMC guidances (ICH, FDA, EMA, etc) and provides prompt regulatory risk assessments and recommendations. Mentors others in regulatory guidance.

Qualifications


Candidates must have a BS, Masters or PhD in Chemistry or related science with a minimum of 10 years relevant experience. Experience in the pharmaceutical, Biotech and/ or other FDA regulated environment is required. Experience in writing regulatory filings required. A minimum of 2 years of experience in leading global CMC dossier preparation is required. Large molecule experience is a plus. Technical background in chemistry or pharmaceutics is required. Proficiency in commonly used computer applications including WORD, EXCEL etc required.

The successful candidate must be able to navigate ambiguous situations and provide consistent support for the CMC technical functions contributing to the Quality submissions. Ability to consistently develop clear and unambiguous direction and structure for the CMC team, with the demonstrated ability to seize opportunities in projects and within CMC organization to influence direction and decisions required. Excellent verbal and written English language skills required. Ability to actively listen and engage in constructive communication with exceptional interpersonal skills in order to help manage technical reports authored by the functions for submission in regulatory applications is essential.

This position requires local travel and up to 10% international travel. This position may be located in Springhouse, PA, Malvern, PA, Raritan, NJ or Titusville, NJ. If the candidate is located in Raritan, NJ, Titusville, or Malvern, PA additional travel to Springhouse, as needed by business, may be required.

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:North America-United States-Pennsylvania-Spring House
Organization: Janssen Research & Development, LLC. (6084)