Please note this is a 7 month contract position.
The Senior Associate will be responsible for managing and overseeing the coordination, compilation and submission of post-market regulatory applications to the U.S. Federal Food & Drug Administration (FDA) and will support day to day Transfusion Medicine Regulatory Operations. The ideal candidate will interpret regulatory requirements and develop strategies to obtain licensure of BLA and clearance of 510(k) products under the direction of Regulatory Management. Will independently make decisions regarding work processes or operational plans and schedules in order to achieve departmental objectives. S/he will represent the company to domestic regulatory agencies, interact with FDA personnel to expedite pending applications and supplements, resolve regulatory matters and manage development meetings for regulatory submissions.
The Senior Associate will provide guidance to business partners regarding regulatory requirements including indications of risk and approximate timing for approvals for planning purposes. Work with team members and business partners to oversee the regulatory aspects of new product launches, the submission of license applications and assessment of the impact that product changes may have on the status of regulatory approvals/clearances.
On occasion, this position may require the participation on New Product Development teams to provide regulatory guidance and to obtain rapid and timely approval of new products. This individual will be responsible for leading Regulatory based projects and/or initiatives to support departmental goals and objectives.
- Under the direction of Regulatory management, submit post-market regulatory supplements for licensed biologics and new 510(k) devices.
- Routine responsibilities include providing Regulatory operational support for currently marketed products, which includes the review and approval of product/process related Change Controls, Design History Files, Labeling and Promotional/Advertising Materials.
- Additional critical roles of this position includes the management of regulatory compliance responsibilities to existing U.S. FDA regulations as they pertain to Annual Report filing for maintenance of product licensure and submission of Biological Product Deviation Reports for the portfolio of BLA products.
- Maintain annual product registrations and GUDID database
- The candidate will ensure timely reporting as applicable to described duties.
- S/he will also maintain collaborative relationships with Product Support, R&D, Operations, quality partners and the International Regulatory Affairs group and will maintain collaborative relationships with internal and external partners including regulators, contract manufacturers/developers, and external companies with established supply/distribution/development agreements.
- Provide audit support during regulatory inspections, both domestic and international.
- The Senior Associate will also lead and/or provide support to departmental initiatives, such as process improvement and streamlining.
- A Bachelor’s Degree in a scientific discipline is required
- A minimum of 5 years of progressive experience in an FDA regulated environment is required.
- Previous experience preparing documentation in support of Regulatory submissions is required and a minimum of direct Regulatory Affairs experience is highly preferred. Experience preparing and submitting BLA supplements, 510Ks and Annual Reports for Biological (BLA) products are preferred.
- Prior interaction with the FDA is preferred. Experience working with cross-functional teams is required in addition to previous aptitude thriving within a complex regulatory environment.
- Candidate must have the ability to provide innovative solutions within the boundaries of U.S. regulations, have the ability to organize data and identify issues or gaps and have the ability to effectively communicate in oral and written forms.
- This position is based in Raritan, NJ and requires up to 20% travel both domestically and internationally.
Please reference job number 1834.