Manager of Regulatory Affairs Jobs in New Jersey
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments...
Con un legado unico en dermatologia y decadas de innovacion de vanguardia, Galderma es el lider emergente en la categoria de dermatologia, presente en aproximadamente 90 paises. Ofrecemos un...
Overview Company Overview At Benjamin Moore, our success is attributable to the employees who dedicate their time and talents to the brand and exemplify our core values of openness, integrity,...
Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees,...
About the role This Senior Manager, Regulatory Affairs - OTC has responsibility for end-to-end regulatory activities for the OTC portfolio, which is comprised primarily of OTC drugs under the Monograph...
Overview Lupin vision was to grow a specialty brand business that launches innovative new products to address unmet medical needs. Since its founding, Lupin's U.S. brand business has been driven...
Director, Regulatory Affairs Advertising & Promotion
- East Hanover, NJ
- 18 days ago
- East Hanover, NJ
- 18 days ago
regulations/guidances, PhRMA guidelines, and company policy....
Associate Director, Regulatory Affairs
- Franklin Lakes, NJ
- 21 days ago
- Franklin Lakes, NJ
- 21 days ago
Comprehensive knowledge of U.S. medical device regulations (FDA), Clinical Practice standards, Laboratory Practice regulations, and Quality System Regulations....
Quality Assurance: Supervise regulatory aspects of quality systems, including compliance with Good Clinical Practices (GCP), and General Data Protection Regulation (GDPR)....
About the Job The primary function of this position is to oversee a full portfolio of approved and unapproved ANDA products. The incumbent might also be designated as U.S. Agent (back-up) for the...
Director, Regulatory Affairs-- Therapeutic Area Business Manager
- Parsippany, NJ
- 30+ days ago
- Parsippany, NJ
- 30+ days ago
At Gilead, were creating a healthier world for all people. For more than 35 years, weve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies...
Director Regulatory Affairs, Tactical Implementation
- Bridgewater, NJ
- 30+ days ago
- Bridgewater, NJ
- 30+ days ago
Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees,...
Overview About Pacira Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners...
Executive Director, Regulatory Affairs CMC
- Bridgewater, NJ
- 30+ days ago
- Bridgewater, NJ
- 30+ days ago
Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees,...
Overview Celldex is a clinical-stage biotechnology company dedicated to developing novel antibody-based treatments that improve the lives of patients with allergic, inflammatory and autoimmune...
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Manager of Regulatory Affairss in New Jersey offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Regulatory Affairs position
- Gene Therapy
- Medical Affairs
- ICH Guidelines
- 21 CFR 820
- Pharmacovigilance
- Quality Systems
- ISO 13485
- Medical Writing
- Drug Development
- GxP
- Immunology
- Change Control
- Toxicology
- Biotechnology
- Quality Management Systems
- Biology
- Oncology
- Medical Device Sales
- Document Management
- Clinical Trials
- Product Launch
- Good Manufacturing Practices
- Clinical Research
- Research and Development
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Product Development
- Strategy Development
- Engineering
- Implementation
- Written Communication
- Military Background
- Analytical Skills
- Auditing
- Verbal Communication
- Collaboration
- Documentation
- Coaching
- Reporting
- Mentoring
- Interpersonal Skills
- Education Experience
- Quality Assurance
- Policy Development
- Filing
- Problem Solving
- Bachelor's Degree
- Project Management
- Regulations
- Microsoft Office
- Research Skills
- Staff Supervision
- Organization
- Teamwork
- Scheduling
- Leadership
- Communication Skills
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