SciLucent, LLC, a Northern Virginia-based scientific consulting firm providing technical, regulatory, and product development services to developers, manufacturers, and marketers of pharmaceuticals and medical devices, seeks an experienced regulatory affairs professional with project management capabilities who can facilitate the planning, coordination, and execution of regulatory deliverables. This person will be an integral member of the Clinical and Regulatory Practice, further enabling SciLucent to ensure the timely preparation of high-quality regulatory submissions, original and any subsequent later amendments, to health authorities. This is a newly created position based on growth. The Regulatory Affairs Project Manager will report to the Director of the Practice.
Identify project objectives, deliverables, and milestones
Create and actively manage submissions plans and timelines
Prepare and distribute reports and trackers to communicate updates and project status
Coordinate the preparation, review, and publishing of submission documents
Contribute to project management process improvement
Coordinate/support cross-functional submission teams
Work closely with regulatory operations to execute electronic submissions
Prepare administrative documents for regulatory submissions
Bachelor’s degree in a relevant scientific discipline (i.e. Biology, Pharmacy, etc.)
Several years of regulatory or other relevant industry experience
Prior project management experience with U.S. regulatory submissions
Demonstrated project management skills
Understanding of electronic submission processes
Strong knowledge of the drug development and regulation process
Excellent understanding of requirements for U.S. regulatory filings
Skills and Capabilities
Proficiency with MS Office applications and Adobe Acrobat; knowledge of MS project, document management systems
Knowledge of CTD and eCTD submission requirements
Excellent written and verbal communication skills
Ability to work independently and as part of a team
Strong interpersonal skills and the ability to effectively work with others
Strong organizational skills
Ability to interpret scientific information
Ability to construct persuasive scientific/regulatory documents
This is a full-time position in our Herndon Virginia office, although remote employees may be considered. We offer a collegial work environment, the opportunity to work with knowledgeable consultants, a competitive salary, flexible benefits, profit sharing, and a tremendous opportunity for growth. Please feel free to visit our website at www.scilucent.com. We look forward to receiving your resume and cover letter which you may send to us at email@example.com.
SciLucent is an equal opportunity employer. We thank all applicants for their interest and effort
in applying for our open position; while all applicants will be considered, only candidates
selected for interviews will be contacted.
Internal Number: 09122019
About SciLucent, LLC
SciLucent, LLC, located in Herndon, Virginia, provides regulatory, scientific, and management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, medical devices, combination products, and dietary supplement ingredients.
Since 1998 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence. Our areas of expertise include manufacturing & development, quality & compliance, nonclinical safety & development, clinical development, regulatory affairs, and regulatory operations.