Director of Regulatory Affairs Jobs in Massachusetts
The Director of Regulatory Affairs in the quality control industry plays an essential role in ensuring that the company's products meet all regulatory standards and compliance requirements. This individual oversees the development and implementation of regulatory strategies for new and existing products, supervises the preparation of regulatory submissions, and maintains communication with regulatory authorities. They also monitor changes in regulations, interpret these updates for relevant departments within the company, and implement necessary changes to maintain compliance. They are responsible for setting the company's standards for quality, safety, and efficacy.
To excel in this role, one should possess excellent analytical skills, strategic thinking, and strong leadership abilities. A deep understanding of regulatory guidelines, ability to interpret complex regulations, and excellent communication skills are essential. They should have a degree in a relevant field, along with certifications such as Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA), and Certified Quality Engineer (CQE). Prior to becoming a Director of Regulatory Affairs, individuals might have roles such as Regulatory Affairs Specialist, Regulatory Affairs Manager, or Quality Control Manager.
Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth...
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Senior Director, Regulatory Affairs Advertising & Promotion (Remote)
- Boston, MA
- 2 days ago
- Boston, MA
- 2 days ago
Job Description General Summary: The Senior Director, Global Regulatory Affairs Advertising Promotion is responsible for providing commercial regulatory strategy and oversight in the development, review...
Regulatory Affairs and Compliance Manager, Part-time
- Burlington, MA
- 5 days ago
- Burlington, MA
- 5 days ago
system requirements for medical devices are effectively established and maintained in accordance with 21 CFR 820, ISO 13485, 21 CFR Part 11, IEC 62304 and other regulations and guidelines as applicable...
Associate Director, Regulatory Affairs (mRNA vaccines)
- Waltham, MA
- 7 days ago
- Waltham, MA
- 7 days ago
Site Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Durham Blackwell Street, Rockville Vaccines, Upper Merion, Waltham Posted Date: Mar 5 2025 Are you looking for a highly...
This position reports to the Director, Regulatory Affairs. Key Responsibilities: Develop and implement global regulatory strategy for assigned projects....
Senior Manager, Regulatory Affairs Advertising & Promotion
- Boston, MA
- 8 days ago
- Boston, MA
- 8 days ago
Responsibilities Serves as subject matter expert on FDA regulations and OPDP guidance governing promotion and prescription drug/ biologic products and disease awareness activities....
Remote WorkSite Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Collegeville TSA, USA - Maryland - Rockville Posted Date: Mar 3 2025 Job Purpose Ensure the development of appropriate...
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...
Sr Director, Regulatory Affairs Advertising, Promotion & Labeling
- Cambridge, MA
- 16 days ago
- Cambridge, MA
- 16 days ago
The Senior Director Regulatory Affairs Advertising, Promotion & Labeling (Sr. Dir....
Remote WorkRole Summary: The Associate Director, Regulatory Affairs will help drive forward our regulatory strategy and operational activities related to Dyne's muscle disease programs....
This position reports to the Director, Regulatory Affairs, Operations and will be in Boston, MA, USA. We will consider other jurisdictions for exceptional candidates....
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with...
Associate Director, Regulatory Affairs Vaccines CMC
- Cambridge, MA
- 21 days ago
- Cambridge, MA
- 21 days ago
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with...
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 WorkDemographic Data for Massachusetts
Moving to Massachusetts? Find some basic demographic data about Massachusetts below.
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Salary for Director of Regulatory Affairs Jobs in Massachusetts
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss in Massachusetts offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director of Regulatory Affairs position
- Clinical Research
- Biology
- Immunology
- Oncology
- Assay Development
- Medical Writing
- Drug Development
- Neuroscience
- Clinical Trials
- Drug Discovery
- Biotechnology
- Infectious Disease
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Biomarkers
- Quality Systems
- Quality Management Systems
- 21 CFR 820
- GxP
- ICH Guidelines
- ISO 13485
- Change Control
- Good Clinical Practice
- Microbiology
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Engineering
- Product Development
- Strategy Development
- Quality Assurance
- Implementation
- Military Background
- Auditing
- Mentoring
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- English
- Regulations
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Leadership
- Communication Skills
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