San Diego, CA
Project Manager, Regulatory Affairs
General Job Description:
Regulatory Affairs Project Manager will be responsible for the project management of regulatory submissions and operations activities as related to the company’s new original market application(s) and all IND submissions to the U.S. and worldwide health agencies.
Position entails the coordination, prioritization and tracking of project submissions. This may include support for both products in early and late stage development and marketed products. The incumbent will apply advanced project management expertise and regulatory skills to support cross-functional teams in meeting submission goals.
Develop and maintain detailed timelines for cross-functional regulatory submission activities and submissions, and assures planning and coordination of activities in a matrixed team environment.
Maintain ownership of the master timeline in MS Project ensuring timely updates to the GANTT chart effectively communicating where delays in dependencies impact the overall timeline.
Use of MS Project Resource functionality to identify under-resourced projects.
Communicate complex and intricate GANTT timelines at a high-level and in a comprehensive manner.
Provide project management oversight in offering identification and mitigation of risks that have impact on deliverables and timings in accordance to departmental and corporate timelines.
Foster effective and productive communications among various functional groups including CMC and Clinical Regulatory Leads, Labeling, Advertising and Promotion, Regulatory Operations, Medical Writing, Quality, Manufacturing, Medical Affairs, and representatives from other departments as appropriate.
Track timelines and deliverables for the original market application (BLA).
Support all Company initiatives as identified by Management and in support of Current Good Manufacturing Practice (cGMP), Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory / compliance requirements.
Comply with U.S. FDA and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Maintain positive and cooperative communications and collaboration with all levels of personnel, customers, contractors, and vendors.
Assists with project management for regulatory audits and inspections, if required.
Bachelor’s degree in a relevant discipline
5-7 years of relevant experience are required
Project Management skill and proficient with MS Suite
Advanced to expert level with MS Project
Biologics and combination products, and familiar with US device regulations
Prior BLA filing experience desired
Must have working knowledge of regulatory requirements specific to US and EU, and preferably have a general awareness of requirements for other regions
Excellent verbal, written, negotiation and interpersonal communications skills
Excellent organizational skills and ability to work on a number of projects with tight timelines
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Regularly required to sit and talk and hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms.
Occasionally required to stoop, kneel, and lift up to 50 pounds. Frequently required to work on a computer up to 8 hours a day.
Application Information & Contact (How to Apply)
To be considered, please send resumes to email@example.com