Director, Regulatory Advertising and Promotion (Whippany, New Jersey, US)
Whippany, New Jersey, United States
$170k-$255k/yrOnsiteFull Time
BayerFrankfurt Stock Exchange: BAYN: Global provider of healthcare medicines and agricultural products.
8+ YOEExtensive knowledge of US FDA regulations for prescription drug advertising; experience leading OPDP submissions; strong analytical, regulatory, and cross-functional collaboration.
Quality Systems Manager – Medical Device Manufacturing
Fairfield, New Jersey, United States
OnsiteFull Time
Weiss-Aug Group: Provides precision metal stamping and injection molding manufacturing solutions.
10+ YOE10+ years in medical device quality systems; ISO 13485 and FDA QSR experience; manage QMS, audits, and regulatory readiness; Bachelor’s in Engineering or Quality.
Electronic QMS platforms, ISO 13485, FDA QSR, 21 CFR Part 820
Phoenix Flavors & Fragrances: Creates and manufactures custom flavor and fragrance ingredients.
2+ YOEHigh school diploma/GED, 2+ years fragrance or flavor compounding experience, ability to operate mixers/pumps/scales and forklifts, follow cGMP/FDA procedures, wear PPE, and work overtime as needed.
TPM Laboratories: Independent contract testing laboratory for pharmaceutical and chemical industries.
10+ YOEBS in Chemistry (advanced degree preferred), 10+ years pharmaceutical/analytical lab experience, method development/validation leadership, expertise in HPLC/UPLC/GC/dissolution/UV/FTIR and cGMP/ALCOA+/FDA/ICH/USP/EP, strong technical writing and communication.
Keystone Industries: Manufactures dental, medical, and cosmetic healthcare products.
5+ YOEMinimum 5 years’ related experience; knowledge of FDA CFR 210/211, cGMP Pharma; FDA CFR 820 / ISO 13485 cGMP Medical Device;Bachelor’s in technical/science.
HaleonLondon Stock Exchange, New York Stock Exchange: HLN: Global leader in consumer healthcare and over-the-counter medicines.
7+ YOEBachelor's in pharmaceutical/life sciences required, 7+ years regulatory affairs experience (FDA/OTC/CMC), proven leadership, FDA interaction experience, strong communication and project management skills.
Teva PharmaceuticalsNYSE: TEVA: Developing and manufacturing generic and specialty pharmaceutical medicines.
7+ YOEBachelor's degree, 7+ years program/project management in regulated industry (preferably pharma), 2+ years working with FDA, vendor management, FDA/REMS regulatory expertise, MS365 skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, MS Project, MS365, database
TevaNYSE: TEVA: Global manufacturer of generic and specialty pharmaceutical products.
10+ YOEBachelor's degree, 10+ years managing large regulated programs, 5+ years working with FDA preferred, experience with REMS and vendor management, strong project management, communication, and FDA regulatory knowledge.
Tris Pharma: Develops and sells medicines for ADHD and neurological disorders.
7+ YOEBachelor's in life sciences/pharmacy/medicine, minimum 7 years regulatory review experience for advertising/promotional materials in pharma/biotech, in‑depth FDA/OPDP knowledge, ability to influence, and experience preparing FDA submissions.
MTF Biologics: Processes human tissue for use in medical transplants.
7+ YOE5+ MgmtBachelor's in science or equivalent, 7+ years experience, 5+ years managerial experience, 5+ years in human tissue or medical device manufacturing, strong knowledge of FDA/QSR/cGMP/ISO, experience with FDA inspections and regulatory submissions; up to 20% travel.
Eikon TherapeuticsNASDAQ: EIKN: Discovers drugs using advanced live-cell imaging and protein tracking.
10+ YOE10+ years regulatory affairs experience; FDA and international regulatory knowledge; clinical regulatory content and submissions; strong communication; individual contributor.
The START Center for Cancer Research: Global network of early-phase oncology clinical trial sites.
MD with board certification in hematology and/or medical oncology; clinical trials experience; knowledge of GCP, FDA regulations; strong collaboration and communication skills.
DM Clinical Research: A clinical research organization conducts FDA-regulated studies at investigative sites.
5+ YOEFMG with at least 5 years of clinical research experience; supervisory experience preferred; proficient in ICH-GCP, FDA regulations, and study conduct.
HaleonLondon Stock Exchange: HLN: Produces and sells over-the-counter consumer health products.
7+ YOEBachelor’s in Pharmaceutical or Life Sciences; 7–10 years regulatory affairs; US FDA; OTC monograph; strong communication and project leadership.
Fingerpaint Group: Marketing and commercialization services for the healthcare industry.
4+ YOE4+ years agency copywriting experience in pharmaceutical/healthcare; strong portfolio, FDA/MLR familiarity, presentation skills, collaboration, and proficiency with Word and PowerPoint.
Microsoft Word, Microsoft PowerPoint, Teams, Slack, Veeva PromoMats
Menasha Corporation: Sustainable corrugated and plastic packaging and supply chain solutions.
10+ YOE10+ MgmtBachelor's degree, 10+ years manufacturing management experience, knowledge of packaging operations and FDA guidelines, strong leadership, financial and quality management skills.