Description
Position Overview:Core responsibilities include developing and executing global regulatory CMC strategy. Provides leadership in coordinating and preparing global CMC submissions, change supplements and follow-up to commitments made to various boards of health. This includes planning, preparation, review and coordination of regulatory submissions. Evaluation of CMC change proposals and documenting evaluation in change management systems. The manager collaborates effectively with across project teams, third party vendors and/or partners to ensure effective project communication and coordination. Knowledge of FDA and ICH guidelines and the Common Technical Document (CTD) are required.
Duties and Responsibilities:
Core responsibilities include, but not limited to the following:
- Leads groups of internal and external CMC professionals to coordinate and prepare CMC supplements and commitments. Development and execution of regulatory plans (filing strategies, preparation, submission and approval).
- Ensure the quality and completeness of documents.
- Communicates with FDA and Health Authorities regarding the submission and approval of CMC dossiers for the assigned projects; liaises with groups such as development, manufacturing and QA/QC and external business partners regarding regulatory compliance.
- Provides advice and interpretation of regulations and guidance's to the company's project teams.
- Coordinate regulatory CMC documentation and change management system in support of global products. Represents Regulatory CMC on interdisciplinary teams and technical project teams to drive development of CMC strategy, outline submission requirements and negotiate timelines for delivery of regulatory CMC submissions.
- Prepares the CMC section of INDs, NDAs, amendments, supplements, annual reports, and international equivalents, including the compilation and review of the required data and scientific reports.
- Reviews and assesses the regulatory impact of change controls/requests for the manufacture, testing and release of development and marketed products in collaboration with internal departments and external business partners.
- Represents Regulatory as needed on cross-functional special projects.
- Performs due diligence and compliance audits.
- Assists in other regulatory functions as projects require.
Qualifications:
- Three-plus years of experience in regulatory affairs, five-plus in the pharmaceutical industry in technical departments such as operations, quality assurance, technology or development functions.
- A minimum of a B.S. degree in the sciences (e.g. Microbiology, Biology, or Chemistry) or engineering.
- Thorough knowledge of FDA regulatory requirements
- Excellent oral and written skills (proficient in Microsoft office, Power Point and Project)
- Demonstrated leadership skills; a positive can-do attitude; ability to establish excellent collaborative internal and external relationships; ability to motivate others
- RAC Certification strongly preferred
For consideration, please e-mail your resume and salary requirements. Please include the position title in the subject of your e-mail.
To find out more about Real Staffing please visit www.realstaffing.com