5-7 years of experience in regulatory affairs with a focus on CMC for clinical studies.
Strong technical writing proficiency in creating regulatory documents.
Familiarity with manufacturing processes, particularly cell cultures and microbial methodologies.
In-depth understanding of ICH guidelines and regulatory procedures in clinical trials.
Experience with electronic documentation systems, including Microsoft and dossier publication platforms.
Responsibilities
File applications and manage government interactions for product regulatory approvals.
Author and submit various PMA supplements and reports to regulatory bodies.
Review and approve engineering and validation study protocols and reports.
Evaluate and approve manufacturing changes related to Class III implantable medical devices.
Leverage experience to meet regulatory goals and mentor junior team members.
Engage in creative problem-solving for regulatory challenges.
Benefits
Opportunity for professional growth in a dynamic regulatory environment.
Work on cutting-edge Class III implantable medical device technologies.
Collaborative team culture emphasizing innovation and creativity.
Potential for leadership roles in complex projects.
Full Job Description
Top Skills:
Familiar with pharmaceutical master batch records and how to author CMC submissions for clinical studies.
Technical writing skills
Familiar with typical manufacturing processes, especially cell cultures
Familiar with microbial methodology
Familiar with ICH and country regulatory procedures for clinical trials
ble to work with electronic systems i.e., Microsoft and dossier publication systems
Responsibilities:
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
Review/approval of engineering study protocols/reports and validation study protocols/reports.
Review and approval of manufacturing changes for Class III implantable medical devices.
May require an advanced degree and 3 to 5 years of direct experience in the field.
Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations.
Relies on extensive experience and judgment to plan and accomplish goals.
Performs a variety of tasks.
May lead and direct the work of others.
wide degree of creativity and latitude is expected.
Requirements:
CMC (Chemistry, Manufacturing, Controls) background in completing clinical submissions
IND/IMPD submission background based on manufacturing batch records
