Manager of Regulatory Affairs Jobs in Newton, MA
Sr Director, Regulatory Affairs Advertising, Promotion & Labeling
- Cambridge, MA (3 miles from Newton, MA)
- 3 hours ago
- Cambridge, MA (3 miles from Newton, MA)
- 3 hours ago
Maintain current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters and policies issues affecting the pharmaceutical/biologics industry....
Remote Work- Cambridge, MA (3 miles from Newton, MA)
- 1 day ago
- Cambridge, MA (3 miles from Newton, MA)
- 1 day ago
Director, Regulatory Affairs Cambridge, MA | On-site An innovative biotech company based in Cambridge is seeking a Director of Regulatory Affairs to serve as the organization's first regulatory...
Director, Regulatory Affairs Strategy
- Boston, MA (6 miles from Newton, MA)
- 3 days ago
- Boston, MA (6 miles from Newton, MA)
- 3 days ago
Location: REMOTE Salary: $190,000.00 USD Annually - $215,000.00 USD Annually Description: Our client is currently seeking a Director, Regulatory Affairs Strategy who will be responsible for...
Quality Systems & Regulatory Affairs Manager
- Boston, MA (6 miles from Newton, MA)
- 4 days ago
- Boston, MA (6 miles from Newton, MA)
- 4 days ago
management and regulatory strategy within WHOOP Support development and maintenance of WHOOPs FDA-compliant QMS, ensuring adherence to 21 CFR 820 and ISO 13485:2016 Coordinate and lead internal audits...
- Wellesley Hills, MA (5 miles from Newton, MA)
- 4 days ago
- Wellesley Hills, MA (5 miles from Newton, MA)
- 4 days ago
Manager, Regulatory Affairs based at our corporate headquarters in Wellesley, MA....
Global Publishing Manager, Regulatory Affairs
- Cambridge, MA (3 miles from Newton, MA)
- 7 days ago
- Cambridge, MA (3 miles from Newton, MA)
- 7 days ago
The Role The Regulatory Operations Global Publishing Manager is responsible for overseeing the planning, creation, and submission of regulatory submissions. In collaboration with the Regulatory...
Remote WorkAssociate Director, Regulatory Affairs CMC
- Cambridge, MA (3 miles from Newton, MA)
- 9 days ago
- Cambridge, MA (3 miles from Newton, MA)
- 9 days ago
Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular...
Senior Manager, Regulatory Affairs (Clinical)
- Boston, MA (6 miles from Newton, MA)
- 11 days ago
- Boston, MA (6 miles from Newton, MA)
- 11 days ago
About the Role: We are seeking a Senior Manager, Regulatory Affairs to join our team....
Senior Manager, Regulatory Affairs
- Waltham, MA (4 miles from Newton, MA)
- 12 days ago
- Waltham, MA (4 miles from Newton, MA)
- 12 days ago
The Senior Manager, Regulatory Operations will report to the Executive Director of Regulatory Operations and will be responsible for submission management across the development pipeline and...
Senior Manager, Regulatory Affairs
- Cambridge, MA (3 miles from Newton, MA)
- 13 days ago
- Cambridge, MA (3 miles from Newton, MA)
- 13 days ago
RAC certification recommended Proficiency with Microsoft Office Applications; Word, Excel, Outlook, Adobe, and regulatory/quality systems. What Now?...
Director, Regulatory Affairs Operations
- Cambridge, MA (3 miles from Newton, MA)
- 14 days ago
- Cambridge, MA (3 miles from Newton, MA)
- 14 days ago
Director of Regulatory Affairs Operations, Ultrasound** The Director of Regulatory Affairs Operations for the Ultrasound business will be responsible for leading a global Regulatory Affairs team...
Director, Regulatory Affairs, LED
- Waltham, MA (4 miles from Newton, MA)
- 14 days ago
- Waltham, MA (4 miles from Newton, MA)
- 14 days ago
system and regulatory product compliance requirements; e.g 21 CFR 820, ISO 13485/9001, QMSR, EU MDR, ISO 14971, UL, CSA, NSF, NMPA, Health Canada We provide competitive salary, an annual incentive...
Senior Manager, Regulatory Affairs
- Waltham, MA (4 miles from Newton, MA)
- 15 days ago
- Waltham, MA (4 miles from Newton, MA)
- 15 days ago
Company Description Position Summary: The Senior Manager, Regulatory Affairs provides regulatory support for oncology products in early- and late-stage development....
Executive Director of Regulatory Affairs
- Cambridge, MA (3 miles from Newton, MA)
- 17 days ago
- Cambridge, MA (3 miles from Newton, MA)
- 17 days ago
A fast-growing oncology business seeks an Executive Director of Regulatory Affairs to lead a remote US hematology team. This role involves managing senior regulatory leaders responsible for...
Senior Director, Regulatory Affairs
- Waltham, MA (4 miles from Newton, MA)
- 17 days ago
- Waltham, MA (4 miles from Newton, MA)
- 17 days ago
Senior Director, Regulatory Affairs Regulatory - Waltham, Massachusetts Visterra is seeking a Regulatory Affairs professional experienced in biologics development to lead our Regulatory Team's...
Demographic Data for Newton, MA
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Salary for Manager of Regulatory Affairs Jobs in Newton, MA
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in Newton, MA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Regulatory Affairs position
- Biomarkers
- Next-Generation Sequencing
- Drug Discovery
- 21 CFR 820
- Internal Audits
- Medical Writing
- Pharmacovigilance
- Assay Development
- ICH Guidelines
- Drug Development
- Immunology
- Change Control
- Quality Systems
- ISO 13485
- Biotechnology
- Neurology
- Oncology
- Medical Device Sales
- Clinical Trials
- Document Management
- Biology
- FDA Regulations
- Research and Development
- Clinical Research
- Resolution
- Product Development
- Medical Terminology
- Strategy Development
- Engineering
- Implementation
- Written Communication
- Verbal Communication
- Military Background
- Investigation
- Collaboration
- Auditing
- Documentation
- Interpersonal Skills
- Mentoring
- Quality Assurance
- Reporting
- Coaching
- Education Experience
- Bachelor's Degree
- Regulations
- Problem Solving
- Project Management
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
- Gene Therapy
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