Senior Regulatory Associate

Where

Pearl River, NY

What you'll be doing

The qualified candidate will focus on regulatory CMC submission and conformance activities for post-approval products. Core responsibilities of this position include coordination and preparation of global CMC submissions including change supplements and follow-up to commitments made to various boards of health. Conformance activities will include but are not limited to evaluating chemistry/manufacturing/control change proposals, documenting evaluation in RCCM (regulatory change control management) or other change control system, and expediting the progression of these changes in a cross-functional environment. Works closely with CMC strategists within, and across, sites to coordinate and prepare CMC supplements and commitments for assigned projects. Ensure the quality and completeness of documents. Support strategies for license conformance activities as needed. Maintain site accreditation and related documents in collaboration with other colleagues. Coordinate regulatory CMC documentation within electronic change management systems in support of global biotx (bios/vaccines) marketed products. Support CMC principals and strategists for activities require interactions with sCNM and hubs/PCOs to ensure consistent conformance practices are in place across the network for handling change management. This position must comply with procedures applicable to this role and may also be influential in updating such procedures to maintain appropriate balance of control and efficiency; must exercise the highest level of integrity in all the tasks performed; must perform tasks in a timely and prompt manner.

What your background should be

This position required two to four years of industrial or academic experience in regulatory affairs, operations, quality assurance, technology or development functions in the vaccine, biological, pharmaceutical or related field. Technical experience in manufacturing, quality or regulatory affairs for vaccines or biologics. Excellent written and oral communication skills, project management skills, interpersonal skills is also required. Ability to work effectively in a team-oriented and matrix environment. Computer skills in Microsoft Office Applications including Word, Acrobat, Excel and Powerpoint and competency to work in additional regulatory database systems.

Required Schooling / Training

A minimum of B.S. degree, preferably in engineering or natural sciences (e.g. microbiology, biology, or chemistry)

Who is the client company

A multinational pharmaceutical corporation which develops and produces medicines and vaccines for a wide range of medical disciplines.

If you are interested in this position, send your resume to apply@kochdavis.com