Director of Regulatory Affairs Jobs
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.
Regulatory Affairs Manager Regulatory Reporting
- Essity
- Philadelphia, PA
- 4 hours ago
- Philadelphia, PA
- 4 hours ago
Regulatory Affairs Manager Regulatory Reporting Who We Are Essity is a global leader in health and hygiene headquartered in Stockholm, Sweden, with a North American headquarters located in...
In PersonAssociate Director, Regulatory Affairs US Lead, Regulatory Science & Execution
- AstraZeneca
- Gaithersburg, MD
- 4 hours ago
- Gaithersburg, MD
- 4 hours ago
The Associate Regulatory Affairs Director, US Lead, Regulatory Science & Execution will be accountable for the development, implementation and maintenance of regulatory strategies for assigned...
In PersonAssociate Director, Regulatory Affairs
- Dendreon Pharmaceuticals LLC
- Seal Beach, CA
- 5 hours ago
- Seal Beach, CA
- 5 hours ago
Job Summary: The Associate Director of Regulatory Affairs develops and executes global regulatory strategies to support product development, lifecycle management, and commercialization objectives....
In PersonSenior Director, Regulatory Affairs (Oncology)
- Exelixis
- Alameda, CA
- 12 hours ago
- Alameda, CA
- 12 hours ago
SUMMARY/JOB PURPOSE: Responsible for driving the development and implementation of global regulatory strategies that align with asset and corporate goals as well as health authority requirements....
In Person- Eikon Therapeutics
- Jersey City, NJ
- 12 hours ago
- Jersey City, NJ
- 12 hours ago
Position We are seeking an experienced Director, Regulatory Affairs to support and execute regulatory strategy across our clinical-stage development programs....
In PersonRegulatory Affairs Specialist Food & Flavor Job Description This role leads regulatory oversight for a defined portfolio of food and flavor products, ensuring full compliance with U.S. and...
In PersonRegulatory Affairs Manager Vascular (on-site)
- Abbott Laboratories
- Santa Clara, CA
- 12 hours ago
- Santa Clara, CA
- 12 hours ago
PMA, PMA/S, IDE, 510(k), etc.), CE (EU MDR) and international submissions Experience with Class II and Class III medical devices Ability to define regulatory strategy....
In PersonDirector of Regulatory Affairs
- Radiant Nuclear
- El Segundo, CA
- 16 hours ago
- El Segundo, CA
- 16 hours ago
Director of Regulatory Affairs Radiant is seeking a highly engaging and effective leader for our regulatory and licensing team....
In PersonSUMMARY: The Director of Regulatory Affairs & Product Stewardship is a senior leadership role responsible for defining, leading, and executing the Company’s global regulatory and product safety strategy...
In PersonManager, Regulatory Affairs- CMC
- Daiichi Sankyo
- Basking Ridge, NJ
- 1 day ago
- Basking Ridge, NJ
- 1 day ago
Job Title: Manager, Regulatory Affairs- CMC Job Requisition ID: 1525 Posting Start Date: 6/1/26 At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through...
In PersonAt RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech...
RemoteDirector - Regulatory Affairs Location : Richmond, VA, USA - 9954 Mayland Drive Hybrid - must be able to attend meetings in the office 2-3 times/week This position comes with competitive pay, a full...
In PersonThe Director, Regulatory Affairs leads global regulatory strategy, reporting, compliance, labeling, and regulatory intelligence to support product development, approval, and market expansion....
In PersonAssociate Director/Senior Manager Regulatory Affairs
- Precigen
- Germantown, MD
- 2 days ago
- Germantown, MD
- 2 days ago
POSITION SUMMARY: Based in Germantown, Maryland Precigen is seeking a highly motivated and experienced Associate Director/Senior Manager, Regulatory Affairs (level based on candidate experience)....
In PersonSenior Director, Regulatory Affairs, Global Regulatory Lead - Development Strategy
- Insmed Incorporated
- Bridgewater, NJ
- 2 days ago
- Bridgewater, NJ
- 2 days ago
About the Role: Were looking for a Senior Director, Regulatory Affairs, Global Regulatory Lead Development Strategy on the Regulatory Affairs team to help us expand whats possible for patients with...
RemoteDirector of Regulatory Affairs Online Courses and Training Opportunities
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Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss 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
- Virology
- Immunology
- Oncology
- Medical Writing
- Drug Development
- Neuroscience
- Biostatistics
- Clinical Trials
- Drug Discovery
- Toxicology
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- ICH GCP
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- Good Laboratory Practice
- ISO 13485
- Microbiology
- Document Management
- Research and Development
- Medical Device Sales
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Analytical Skills
- Quality Assurance
- Engineering
- Strategy Development
- Auditing
- Written Communication
- Process Improvement
- Documentation
- Coaching
- Mentoring
- Interpersonal Skills
- Writing Skills
- Implementation
- Verbal Communication
- Reporting
- Education Experience
- Collaboration
- Bachelor's Degree
- Regulations
- Research Skills
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Teamwork
- Leadership
- Communication Skills
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