Manager of Regulatory Affairs Jobs in Maryland
A Manager of Regulatory Affairs in the quality control industry plays a pivotal role in ensuring that the company's products meet all necessary regulatory standards. Their key responsibilities include developing and implementing regulatory strategies, monitoring changes to regulatory guidelines, and ensuring the organization's compliance with these changes. They also engage in the preparation, review, and submission of regulatory documents to regulatory agencies. To effectively execute these responsibilities, they liaise with various stakeholders within and outside the organization, such as product developers, project managers, and regulatory bodies.
Important skills and certifications for a Manager of Regulatory Affairs include strong organizational and project management skills, excellent written and verbal communication skills, as well as a keen eye for detail. Analytical thinking and problem-solving skills are also crucial in this role. Additionally, they should possess relevant certifications such as the Regulatory Affairs Certification (RAC), which is recognized worldwide as the leading credential for regulatory professionals in the healthcare product sector. Before becoming a Manager of Regulatory Affairs, a person may have roles such as a Regulatory Affairs Specialist, Quality Control Analyst, or a Quality Assurance Associate. These roles would provide the necessary exposure and experience in quality control and regulatory affairs needed for the managerial position.
Associate Director, Regulatory Affairs - Cmc (Cell Therapy)
- Gaithersburg, MD
- 2 days ago
- Gaithersburg, MD
- 2 days ago
The Associate Director, Regulatory Affairs, CMC - Cell & Gene Therapies (CGT) supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of Cell...
Director, Regulatory Affairs, Regulatory Science & Execution
- Gaithersburg, MD
- 14 days ago
- Gaithersburg, MD
- 14 days ago
This is what you will do: The Regulatory Affairs Director (RAD), Regulatory Science & Execution will be accountable for the development, implementation and maintenance of regulatory strategies for...
AstraZeneca - Vaccines & Immune Therapies At AstraZeneca, we are committed to developing and delivering transformative vaccines and antibodies, providing long-lasting immunity for millions of...
AstraZeneca - Vaccines & Immune Therapies At AstraZeneca, we are committed to developing and delivering transformative vaccines and antibodies, providing long-lasting immunity for millions of...
Director, Regulatory Affairs - CMC (Cell Therapy)
- Gaithersburg, MD
- 30+ days ago
- Gaithersburg, MD
- 30+ days ago
The Director, Regulatory Affairs - CMC (CGT) is responsible for supporting the development and successful performance of the CMC regulatory strategy for the innovative pipeline of AstraZeneca's C...
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Responsibilities: Join Thermo Fisher Scientific Inc. as a Manager, Regulatory Affairs, and play a pivotal role in molding...
Possess and maintain a mastery of FDA regulations, inferences, and regulatory requirements, and have the capability to interpret and apply them to COVID-19 Product Development and Fielding efforts....
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Bethesda, MD
- 90+ days ago
- Bethesda, MD
- 90+ days ago
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely...
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Salary for Manager of Regulatory Affairs Jobs in Maryland
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in Maryland offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Regulatory Affairs position
- Clinical Research
- Biochemistry
- Biology
- Immunology
- Assay Development
- Medical Writing
- Scientific Writing
- Drug Development
- Clinical Trials
- Drug Discovery
- Toxicology
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- ICH GCP
- Internal Audits
- Quality Management Systems
- Quality Systems
- Supplier Auditing
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- GxP
- Change Control
- Medical Device Sales
- Microbiology
- Document Management
- FDA Regulations
- Research and Development
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Process Improvement
- Quality Assurance
- Implementation
- Auditing
- Verbal Communication
- Written Communication
- Mentoring
- Collaboration
- Documentation
- Coaching
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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