HireDiversity

Spring House, PA, US

Senior Scientist — Regulatory CMC Dossier-6668130109

Description

Janssen Research & Development L.L.C. a member of the Johnson & Johnson Family of Companies is recruiting a Senior Scientist - Regulatory CMC Dossier to be located in Spring House, PA, Malvern, PA, Titusville, NJ or Raritan, 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.

The Senior Scientist - Regulatory CMC Dossier is responsible to manage the development of CTD Quality sections to support CMC dossier submissions with guidance from senior staff. Provides technical oversight and authoring of the CMC dossier (CTD 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; delivers results; makes the customer central with normal supervision.

The Senior Scientist - Regulatory CMC Dossier manages the development, planning and submission process for Quality related CTD sections with appropriate 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.

The Senior Scientist - Regulatory CMC Dossier continues to develop a knowledge of regulatory guidance. Provides interpretation with some guidance from senior staff of relevant CMC guidance (ICH, FDA, EMEA, etc) and provides prompt regulatory risk assessments and recommendations.

Qualifications


A minimum of a Bachelor's degree in Chemistry, Biology or a related science with a minimum of 7 years relevant experience required. Experience in the pharmaceutical, Biotech and/ or other FDA regulated environment is required. A Master's or PhD in Chemistry, Biology or a related science is preferred. A minimum of 2 years of experience in leading global CMC dossier preparation and filings is preferred. Large molecule experience a plus. Technical background in chemistry or pharmaceutics is 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)