Director of Regulatory Affairs Jobs in Frederick, MD
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.
Associate Director, Regulatory Affairs - Cmc (Cell Therapy)
- Gaithersburg, MD (23 miles from Frederick, MD)
- 3 days ago
- Gaithersburg, MD (23 miles from Frederick, MD)
- 3 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 (23 miles from Frederick, MD)
- 15 days ago
- Gaithersburg, MD (23 miles from Frederick, MD)
- 15 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...
Senior Regulatory Affairs Director
- Gaithersburg, MD (23 miles from Frederick, MD)
- 28 days ago
- Gaithersburg, MD (23 miles from Frederick, MD)
- 28 days ago
AstraZeneca - Vaccines & Immune Therapies At AstraZeneca, we are committed to developing and delivering transformative vaccines and antibodies, providing long-lasting immunity for millions of...
Senior Regulatory Affairs Director
- Gaithersburg, MD (23 miles from Frederick, MD)
- 30+ days ago
- Gaithersburg, MD (23 miles from Frederick, MD)
- 30+ days ago
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 (23 miles from Frederick, MD)
- 30+ days ago
- Gaithersburg, MD (23 miles from Frederick, MD)
- 30+ days ago
This position may be based in Santa Monica, CA or Gaithersburg, M D and reports to the Senior Director, CMC Regulatory Affairs (CGT)....
Systems, and import/export requirements Experience as the RA representative on project core teams Strong communication and teamwork skills Ability to lead multiple projects and meet deadlines Capacity...
- Fort Detrick, MD (6 miles from Frederick, MD)
- 90+ days ago
- Fort Detrick, MD (6 miles from Frederick, MD)
- 90+ days ago
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....
Demographic Data for Frederick, MD
Moving to Frederick, MD? Find some basic demographic data about Frederick, MD below.
Director of Regulatory Affairs Online Courses and Training Opportunities
Title Synonyms
Users interested in this job title also searched for the following job title
Salary for Director of Regulatory Affairs Jobs in Frederick, MD
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss in Frederick, MD 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
- Biochemistry
- Biology
- Immunology
- Assay Development
- Medical Writing
- Scientific Writing
- Drug Development
- Clinical Trials
- 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
- Medical Device Sales
- Microbiology
- Document Management
- FDA Regulations
- Research and Development
- Complaint Resolution
- 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
- Bachelor's Degree
- Filing
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
Other Career Titles
Here are some other career titles that require similar skills
Director of Regulatory Affairs Related Career Advice Articles
Top Skills and Quality Control Training You Need to Get Promoted
Ready to take your quality control career to the next level? Seek out quality control training for these highly desired skills for quality control jobs.
Read article »
Quality Assurance vs. Quality Control: What’s the Difference?
Deciding on a career in QA vs. QC can be tough if you don’t know which is which. Find out the difference between quality control and quality assurance.
Read article »