- 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 include managing regulatory aspects of product and projects including applying leadership to coordinate preparation of global CMC submissions including change supplements and follow-up to commitments made to various boards of health. The associate director will develop robust, global CMC strategies to ensure identification of key issues. Develop risk assessment and mitigation plans. Discuss/negotiate complex issues with regulatory agencies in support of new dossiers and life-cycle management. Conformance activities will include but are not limited to coordinating the evaluation of 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. In both submission and compliance arenas, the role will include project management of work that is performed by others through accountabilities as a team leader, sometimes without direct supervisory accountability. This work is often performed under tight timelines.
What your background should be
- The skills and abilities required to perform this job are normally achieved through more than ten years of industrial or academic experience in regulatory affairs, operations, quality assurance and technology or development functions as practiced in the vaccine, biological, pharmaceutical or related field. General understanding of common technical document (CTD) structure and project management skills required. Computer skills in Microsoft Office applications competency to work in additional regulatory database systems is expected. Attention to detail and accuracy and interpersonal skills are required. Excellent written and oral communication skills required.
Required Schooling / Training
- Achievement of a minimum of B.S. degree, preferably in engineering or natural sciences (e.g. microbiology, biology, or chemistry). Others (e.g. business) may be acceptable when supplemented with technical work experience. Achievement of an advanced degree may facilitate achievement of the requisite skills with less experience.
Who is the client company
- This multinational pharmaceutical corporation develops and produces medicines and vaccines for a wide range of medical disciplines.
- If you are interested in this position, send your resume to firstname.lastname@example.org