Director of Regulatory Affairs Jobs in Mahwah, NJ
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.
Senior Manager, Regulatory Affairs, Mako and Enabling Technologies
- Mahwah, NJ
- 5 days ago
- Mahwah, NJ
- 5 days ago
Work Flexibility: Remote or Hybrid or Onsite We are currently seeking a Senior Manager, Regulatory Affairs to join our Joint Replacement Division (Mako and Enabling Technologies Business Unit)....
Senior Manager, Regulatory Affairs Advertising and Promotion - REQ-3310
- New York, NY (24 miles from Mahwah, NJ)
- 6 days ago
- New York, NY (24 miles from Mahwah, NJ)
- 6 days ago
regulations, OPDP standards, and industry best practicesProficient in Veeva Vault (PromoMats and MedComms) and Microsoft OfficeEducation, Qualifications and Experience:Bachelor's degree in scientific...
- New York, NY (24 miles from Mahwah, NJ)
- 8 days ago
- New York, NY (24 miles from Mahwah, NJ)
- 8 days ago
The Role We are seeking a Regulatory Affairs Manager to join our team to lead and broaden the impact of our ongoing regulatory affairs efforts across the United States. You will be responsible for...
Senior Manager (Director), Regulatory Affairs & Pharmacovigilance, USA
- New York, NY (24 miles from Mahwah, NJ)
- 10 days ago
- New York, NY (24 miles from Mahwah, NJ)
- 10 days ago
The opportunity of Senior Manager (Director), Regulatory Affairs & Pharmacovigilance....
- Parsippany, NJ (19 miles from Mahwah, NJ)
- 15 days ago
- Parsippany, NJ (19 miles from Mahwah, NJ)
- 15 days ago
Who we are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across...
Director of Regulatory Affairs
- New York, NY (24 miles from Mahwah, NJ)
- 21 days ago
- New York, NY (24 miles from Mahwah, NJ)
- 21 days ago
Director of Regulatory Affairs DepartmentPROFESSIONAL REV ORG Location Bronx Job ID119859 Civil Service ClassificationManagerial Hire In Rate$150,000.00 (for employees new to HHC) Salary Range$150,000.00...
Director, Regulatory Affairs Global Labeling
- Parsippany, NJ (19 miles from Mahwah, NJ)
- 22 days ago
- Parsippany, NJ (19 miles from Mahwah, NJ)
- 22 days ago
Director, Regulatory Affairs Global Labeling in Parsippany , New Jersey At Gilead, we're creating a healthier world for all people....
Senior Manager, Regulatory Affairs, Growth Markets
- Nutley, NJ (17 miles from Mahwah, NJ)
- 22 days ago
- Nutley, NJ (17 miles from Mahwah, NJ)
- 22 days ago
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisais human health care (hhc) mission. Were a growing...
Director, Regulatory Affairs Business Operations
- Tarrytown, NY (17 miles from Mahwah, NJ)
- 24 days ago
- Tarrytown, NY (17 miles from Mahwah, NJ)
- 24 days ago
This role resides in the Global Development area of Regulatory Affairs, Global Patient Safety and Development Quality (RA, GPS and DQ) and the Director of Strategy Planning and Operations role...
HR Control Manager - Regulatory Affairs - Vice President
- Jersey City, NJ (24 miles from Mahwah, NJ)
- 30+ days ago
- Jersey City, NJ (24 miles from Mahwah, NJ)
- 30+ days ago
audits and external regulatory exams supporting HR Regulatory Affairs Prepares committee materials on regulatory exams and compensation matters Partner on regulatory matters with EMEA Regulatory Affairs...
Senior Director of Regulatory Affairs
- New York, NY (24 miles from Mahwah, NJ)
- 26 days ago
- New York, NY (24 miles from Mahwah, NJ)
- 26 days ago
Senior Director of Regulatory Affairs Job Ref: 112166 Category: Professional Department: OFFICE CORPORATE COMPLIANCE Location: 50 Water Street, 7th Floor, New York, NY 10004 Job Type: Regular Employment...
Remote WorkAssociate Director, Regulatory Affairs Advertising and Promotion
- Parsippany, NJ (19 miles from Mahwah, NJ)
- 29 days ago
- Parsippany, NJ (19 miles from Mahwah, NJ)
- 29 days ago
Maintains a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products....
Director, Regulatory Affairs, Digital Assets
- New York, NY (24 miles from Mahwah, NJ)
- 30+ days ago
- New York, NY (24 miles from Mahwah, NJ)
- 30+ days ago
This role is for a Director of Regulatory Affairs on the US Government Affairs & Public Policy team with a legal background and deep expertise in financial services policy....
Director, Regulatory Affairs Strategy - Oncology
- Tarrytown, NY (17 miles from Mahwah, NJ)
- 30+ days ago
- Tarrytown, NY (17 miles from Mahwah, NJ)
- 30+ days ago
The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products....
Associate Director, Regulatory Affairs - Genetic Medicine & Thrombosis
- Tarrytown, NY (17 miles from Mahwah, NJ)
- 60+ days ago
- Tarrytown, NY (17 miles from Mahwah, NJ)
- 60+ days ago
The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products....
Demographic Data for Mahwah, NJ
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Salary for Director of Regulatory Affairs Jobs in Mahwah, NJ
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss in Mahwah, NJ 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
- Bioinformatics
- Biology
- Immunology
- Medical Writing
- Drug Development
- Clinical Trials
- Biomedical Engineering
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Internal Audits
- Quality Management Systems
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- Good Clinical Practice
- Microbiology
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Quality Assurance
- Process Improvement
- Implementation
- Auditing
- Written Communication
- Verbal Communication
- Strategic Planning
- Documentation
- Mentoring
- Collaboration
- Reporting
- Education Experience
- Interpersonal Skills
- Coaching
- Bachelor's Degree
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Teamwork
- Staff Supervision
- Organization
- Research Skills
- Leadership
- Communication Skills
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