Lorena G. Quinlan
Regulatory Affairs Manager, Specialty pharmaceuticals
Raleigh, NC · (919) 555 0165 · name@example.com · linkedin.com/in/lorenagquinlan
Key Qualifications
EXPERIENCE
Twelve years in regulatory affairs with five years managing associates and specialists
INDUSTRIES
Specialty pharmaceuticals, central nervous system and pain products
SPECIALTIES
New drug application ownership, agency meetings, information request responses, labeling negotiation
SYSTEMS
Veeva Vault, TrackWise, Lorenz docuBridge, Smartsheet
CREDENTIALS
Regulatory Affairs Certification, Regulatory Affairs Professionals Society
TEAM
Two regulatory affairs associates and one regulatory operations specialist
EDUCATION
Master of science in regulatory science, University of North Carolina at Chapel Hill
Executive Summary
Regulatory affairs manager who owns submissions end to end for a specialty pharmaceutical company. Twelve years in the field, five leading a team of three. Signs out new drug application content, chairs meetings with the review division, and is the named contact the Food and Drug Administration writes to.
Signature Achievements
- Owned and filed an original new drug application of 21,000 pages that was accepted for filing with no refuse to file issue.
- Chaired a type B meeting on the development program and secured written agreement on the pivotal study endpoint.
- Answered 41 information requests during review, every one inside the requested response window.
- Negotiated the final prescribing information over three labeling rounds and kept two claims the company judged commercially critical.
- Cleared a complete response letter by leading the resubmission package and the site actions behind it, with approval granted six months later.
- Grew the group from one associate to three and moved submission publishing in house, saving roughly 240,000 dollars a year in vendor fees.
Professional Experience
Regulatory Affairs Manager
Neuse River Therapeutics, Raleigh, NC 2021 to present
Owns regulatory strategy and submissions for two marketed products and one program in registration for a company of 240 people.
- Holds signature authority on submissions to the Food and Drug Administration and is the listed agency contact.
- Plans and chairs meetings with the review division, including the briefing package and the internal rehearsal.
- Approves responses to information requests and negotiates the wording of the prescribing information.
- Sets the filing strategy for post approval changes and decides the reporting category for every change control.
- Manages three staff, sets their objectives and reviews everything before it leaves the department.
Senior Regulatory Affairs Specialist
Cape Fear Pharmaceuticals, Wilmington, NC 2017 to 2021
Led submission content for one marketed product and two investigational new drug applications.
- Authored module 2 summaries and coordinated module 3 content from the manufacturing sites.
- Prepared annual reports and safety reporting submissions.
- Drafted responses to agency questions for the director to approve.
- Assessed the regulatory impact of manufacturing changes at two contract sites.
Regulatory Affairs Associate
Piedmont Clinical Sciences, Durham, NC 2014 to 2017
Submission compilation and archive support for a small clinical development company.
- Compiled and formatted content for investigational new drug application amendments.
- Maintained the regulatory archive and the commitment tracker.
- Prepared administrative forms and cover letters for review.
Licensure and Certification
Regulatory Affairs Certification, Regulatory Affairs Professionals Society
Member, Drug Information Association
Education
Master of science in regulatory science, University of North Carolina at Chapel Hill
Bachelor of science in biology, East Carolina University
Core Skills
New drug application ownership · Agency meetings · Information request responses · Labeling negotiation · Regulatory strategy · Post approval change filings · Team leadership · Veeva Vault · Briefing package preparation · Submission publishing · Commitment management · Complete response resolution