Spécialiste principal des affaires réglementaires Position Available In Sullivan, Tennessee
Tallo's Job Summary: Join a dynamic regulatory affairs team as a Senior Regulator Affairs Specialist in the Bristol-Kingsport, TN metro area. Salary is commensurate with experience. Responsibilities include compiling and reviewing FDA submissions, assessing manufacturing changes, and managing regulatory projects. The ideal candidate should have knowledge of oral solid dosage pharmaceuticals, strong communication and project management skills, and experience in the pharmaceutical industry.
Job Description
Rejoignez une équipe dynamique des affaires réglementaires où vous jouerez un rôle clé dans la compilation et l’examen des soumissions à la FDA, de l’étiquetage et des évaluations des modifications pour les produits pharmaceutiques à dosage solide par voie orale. Leverage your regulatory expertise and project management skills to drive impactful, cross-functional initiatives in a fast-paced, compliance-driven environment.
Job Title :
Senior Regulator Affairs Specialist Location :
Bristol-Kingsport, TN metro area ( relocation assistance provided )
Salary :
Commensurate with experience
RESPONSIBILITIES
Compilation/review of Annual Reports, original applications, amendments, and supplements and product labeling Assessment of proposed changes to manufacturing facilities, processes, and/or controlled documents Compilation and review of FDA Submissions (e.g., NDA/ANDA Filings, Amendments, Supplements, Annual Reports, DMF Updates, labeling packages) as agreed upon with change control review/approval and management.
KNOWLEDGE, SKILLS AND ABILITIES
Familiarity with oral solid dosage pharmaceuticals Competency with regulations, policies, and procedures relating to company and regulatory guidelines Ability to multitask and manage multiple projects with interdisciplinary teams Effective communication (verbal and written) with external and internal customers, vendors, and regulators Participation and familiarity with post-approval submissions to FDA, and with ad/promo materials to FDA as well as hands-on experience reviewing and approving labeling and marketing regulatory materials Strong planning and organizational / project / workload management skills Ability to work under deadline pressure / rapidly shifting priorities and manage multiple projects Strong ability to work independently as well as in a team environment Ability to drive projects to completion with minimal guidance Solid interpersonal (verbal and written) communication skills at all levels Formal project management skills area plus Broad career progression including experience in multiple departments in pharmaceutical, drug development and/or manufacturing industry is a plus.
