Associate Manager Regulatory Affairs Compliance

Job description

Johnson & Johnson Consumer Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an ASSOCIATE MANAGER RA COMPLIANCE to be located in Fort Washington, PA or Skillman, NJ.

Johnson & Johnson Family of Companies touches more than a billion people's lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Group of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and Over-The-Counter (OTC) products.

The ASSOCIATE MANAGER RA COMPLIANCE responsibilities include the interaction and collaboration with the Regulatory Franchise, Procurement, External Manufacturing, Project Management, Technical Operations, and external contractors/vendors with specific product responsibilities, within the global R&D organization.

The position responsibilities include:

· Compile product information for FDA drug listing in the format for the conversion to Structured Product Labelling (SPL).
· Responsible for oversight of local and off-shore resources that support the FDA drug listing processes. Compile metrics report.
· Responsible for the Establishment Registrations and NDC yearly self-Certification in the format for the conversion to Structured Product Labelling (SPL) for US, Beerse and Latina locations. Responsible for Labeler Codes (CIDER Direct) is up today.
· Work directly with Reed-Tech (external vendor) to ensure SPL are created and any discrepancies addressed prior submission to the FDA. Ensure updates to the vendor SPL process/system are evaluated and in compliance within FDA requirements.
· Responsible for submissions of Drug Listing to DailyMed and Life Science Portal for Global Unique Device Identification Database ( GUDID).
· Responsible for translation of National Drug Code (NDC) information into SAP Master Data & cMAT.
· Responsible for the review, approval, deliverables and action items of Change Controls impacting the product Drug Listing for products marketed in US.
· Provide product information for Tradeflow/Trade Compliance database for the transportation of product.
· Assist and prioritize any FDA Notice of Actions for importation and the release of products being held at the border.
· Responsible to identify and lead process improvements within the global R&D organization.

Desired profile

Qualifications :

·  A minimum of Bachelor's degree is required.
·  Minimum of 5 years work experience in a highly regulated industry is required.
·  Quality/ Compliance experience is preferred.
·  One plus year of people management experience is preferred.
·  Strong competency with standard office automation packages (notably the Microsoft – Office suite and Adobe Acrobat) is required
·  Process Improvements Green Belt certification or any similar certification is required.
·  Knowledge of regulatory requirements as applicable in the US for the marketing of medicinal, non-medicinal and device products is required
·  Up to 10% local travel between sites (Fort Washington and Skillman) is required.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.