Director of Regulatory Affairs Jobs in Parsippany, 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.
Manager: Teva Pharmaceuticals USA Inc. is seeking a Manager, Regulatory Affairs (Parsippany, NJ) to prepare, review & approve regulatory submissions & guidance. Bach degree in Chem, Pharmacy,...
Senior Manager, Regulatory Affairs
- New York, NY (22 miles from Parsippany, NJ)
- 2 days ago
- New York, NY (22 miles from Parsippany, NJ)
- 2 days ago
Company Overview: Protara Therapeutics is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara's portfolio...
Associate Regulatory Affairs Manager - Beauty & Wellbeing and Personal Care
- Englewood Cliffs, NJ (23 miles from Parsippany, NJ)
- 3 days ago
- Englewood Cliffs, NJ (23 miles from Parsippany, NJ)
- 3 days ago
ABOUT UNILEVER INTERNATIONAL Unilever International is Unilever's White Space Arm! of Unilever. With a TO of 1.4 billion it is 6th largest, most profitable, among fastest growing (Double digit...
Regulatory Affairs Director - Oncology
- New York, NY (22 miles from Parsippany, NJ)
- 4 days ago
- New York, NY (22 miles from Parsippany, NJ)
- 4 days ago
Are you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on! About...
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Director, Regulatory Affairs Strategy
- New York, NY (22 miles from Parsippany, NJ)
- 10 days ago
- New York, NY (22 miles from Parsippany, NJ)
- 10 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 contributing...
Director, Regulatory Affairs - Electrophysiology
- Parsippany, NJ
- 10 days ago
- Parsippany, NJ
- 10 days ago
Job Overview Line Management responsibilities for a team of Regulatory staff or may be responsible for the performance of one or more Regulatory Affairs sites. Responsible for the development of...
Senior Manager, Regulatory Affairs, Mako and Enabling Technologies
- Mahwah, NJ (19 miles from Parsippany, NJ)
- 20 days ago
- Mahwah, NJ (19 miles from Parsippany, NJ)
- 20 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 (22 miles from Parsippany, NJ)
- 21 days ago
- New York, NY (22 miles from Parsippany, NJ)
- 21 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 (22 miles from Parsippany, NJ)
- 24 days ago
- New York, NY (22 miles from Parsippany, NJ)
- 24 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...
Director, Regulatory Affairs (Global Labeling)
- Bridgewater, NJ (21 miles from Parsippany, NJ)
- 25 days ago
- Bridgewater, NJ (21 miles from Parsippany, NJ)
- 25 days ago
Join a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of...
Senior Manager (Director), Regulatory Affairs & Pharmacovigilance, USA
- New York, NY (22 miles from Parsippany, NJ)
- 25 days ago
- New York, NY (22 miles from Parsippany, NJ)
- 25 days ago
The opportunity of Senior Manager (Director), Regulatory Affairs & Pharmacovigilance....
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 (22 miles from Parsippany, NJ)
- 30+ days ago
- New York, NY (22 miles from Parsippany, NJ)
- 30+ 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
- 30+ days ago
- Parsippany, NJ
- 30+ 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 (13 miles from Parsippany, NJ)
- 30+ days ago
- Nutley, NJ (13 miles from Parsippany, NJ)
- 30+ 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...
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Director of Regulatory Affairss in Parsippany, 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
- Medical Terminology
- Clinical Research
- Biology
- Immunology
- Oncology
- Assay Development
- Neurology
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Biomarkers
- Internal Audits
- Quality Systems
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Military Background
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Mentoring
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Coaching
- Regulations
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Leadership
- Communication Skills
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