HireDiversity

Raritan, NJ, US

Project Manager, Regulatory Affairs — Transfusion Medicine-2586120402

Description

Ortho Clinical Diagnostics, a member of Johnson & Johnson's Family of Companies, is recruiting for a Project Manager (M1) Regulatory Affairs, located in Raritan, NJ. This position will lead the Regulatory Affairs Transfusion Medicine Line of Business within the OCD franchise.

Ortho Clinical Diagnostics serves the transfusion medicine community and laboratories around the world. We're a leading provider of total solutions for screening, diagnosing, monitoring and confirming diseases early, before they put lives at risk. Our single focus is to help hospitals, laboratories and blood centers worldwide deliver results that help patients experience a better quality of life.

The Project Manager, under limited supervision, will be responsible for Managing and overseeing the coordination, compilation and submission of regulatory applications to regulatory agencies and will support day to day Regulatory Operations. The ideal candidate will interpret regulatory requirements and develop strategies to obtain registrations and for translating the regulatory strategies into executable plans for the Transfusion Medicine Line of business and administer day-to-day Regulatory Affairs operations or Strategic Regulatory Affairs by directly or indirectly managing teams of employees or managing third-party joint manufacturing relationships. S/he will represent OCD to domestic regulatory agencies, interact with FDA personnel to expedite pending applications, will resolve regulatory matters and manage development meetings for regulatory submissions. Will work independently to identify and obtain data needed to support regional regulatory strategies.

The Project Manager will be supporting post-approval products and new product development and approval activities in the Transfusion Medicine line of business. The Project Manager ensures the strategy meets regulatory requirements over the lifecycle of the product and CMC regulatory strategy is in alignment with the global regulatory strategy, regional strategies and commercial strategy. The Project Manager will provide guidance to business partners regarding regulatory requirements including indications of risk and approximate timing for approvals for planning purposes.

This position will also participate as the Regulatory Lead on project teams and represents Regulatory Affairs by providing regulatory expertise on CMC related initiatives to facilitate successful project implementations. The Project Manager, Regulatory Affairs will be responsible for escalating issues to Regulatory Affairs Management that affect registration, regulatory compliance and continued lifecycle management of the product. Additionally, this role will be responsible for preparing regulatory dossiers for submission to U.S. and/or EU Health Authorities (FDA, EMA, and Notified Bodies) and actively participating on Global Regulatory Team(s) to develop global approval submission plans. The successful candidate will stay abreast of all pertinent US and/or global laws, regulations and guidance to provide accurate regulatory assessments of CMC changes to teams and executes regulatory planning and implementation while assuring a seamless transition of supported products from the US to the Global post marketing regulatory groups.

Qualifications


A minimum of Bachelor's degree in a Scientific, Technical or related discipline is required. An advanced degree and/or RAC certification is preferred. A minimum of 8 years overall experience in a regulated industry is required. A minimum of 4 years overall experience in Regulatory Affairs is required. Knowledge of FDA regulations related to pharmaceutical or biologic products and of cGMP regulations is required. Pharmaceutical, biologic, or combination product Regulatory experience is strongly preferred. Regulatory CMC or CMC experience is required. Experience developing regulatory strategies and an understanding of biological or drug product development is preferred.

Experience with IVDs is preferred. Regulatory knowledge or experience outside the U.S. is preferred. Experience as a team lead, project lead, or people manager is required. The ability to balance changing priorities and work with cross functional teams is required. The ability to effectively communicate with internal and external customers of multiple levels is required. The ability to manage multiple projects required. This position is based in Raritan, NJ and requires up to 10% travel both domestically and internationally.

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-New Jersey-Raritan
Organization: OCD Inc. (6118)
Travel:Yes, 10% of the time