Manager, Regulatory Affairs Pompe


Job ID 17-00141

Industry Pharma

Job Type Permanent

Location Cranbury, NJ

Description

POSITION SUMMARY
The Manager of Regulatory Affairs Pompe will report to the Director, Regulatory Affairs and is accountable for the preparation, coordination and management of regulatory submissions supporting the POMPE program. The incumbent will work within a group setting to act coordinate assigned Regulatory Affairs activities with other functional areas including external CROs, partners, and consultants in the planning, organizing, and preparing of regulatory documents as required for submission to governmental regulatory agencies. This individual will have a solid understanding of FDA regulations and ICH guidance's and experience with regulatory submissions, including INDs, international clinical trial applications, and marketing applications in Common Technical Document format. The ideal candidate will have excellent written and effective verbal communication skills, proficient in project management, is flexible, and able to work in a fast paced environment.
 

ROLES AND RESPONSIBILITIES
Actively contribute to the operational implementation of regulatory strategy for assigned projects.
Prepare, coordinate, manage or maintain regulatory submissions (e.g., INDs, CTAs, amendments, safety reports, DSUR, annual reports, meeting packages, etc.) in accordance with applicable regulations. This includes ability to coordinate identified regulatory requirements into reliable submission plans; develop & maintain timelines; coordinate internal/external authoring/review/comment adjudication and finalization (submission and archival).
Provide review and comment during document preparation, including consideration of regulatory/ICH guidance/requirements pertaining to document strategic purpose and content.
Interface with external regulatory groups (e.g., CRO, partner, consultants, etc.) in the preparation/review/compilation/finalization/submission/posting of regulatory submissions.
Coordinate Regulatory Affairs activities with other functional areas as required including representation Regulatory Affairs in cross-functional team meetings.
Provide regulatory support for clinical operations activities (e.g., review of essential documents, and development and review of consent forms, etc.).
Initiate and/or contribute to local process improvements which have an impact on Regulatory Affairs, including the authoring and review of standard operating procedures (SOPs).
Remain current on regulatory requirements (e.g., Domestic and International) supporting the regulatory strategy and clinical operations related activities.).



Qualifications

REQUIREMENTS
Bachelor's or Master's degree in a scientific discipline or equivalent.
Regulatory Affairs Certification is preferred yet not required.
Candidate must have at least 5 to 7 years of Regulatory Affairs experience in the pharmaceutical or biotechnology industry, experience with clinical development of biologics in rare disease indications is preferred, yet not necessarily required.
Experience working with innovative products and implementation of creative development strategies are highly desirable.
Must have a solid understanding of FDA regulations and ICH guidance's, as well as a comprehension of the biologics drug development process.
Experience with regulatory submissions, including INDs, international clinical trial applications, and marketing applications in Common Technical Document format, is essential.
Able to handle multiple projects and exercise good judgment in prioritizing tasks.
Demonstrated ability to work independently and within a group setting, and to interact effectively with various functional groups.
Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
High level of attention to detail, and be proficient with Microsoft Office applications, Adobe and document management templates.
TRAVEL
Domestic and international travel required