Director of Regulatory Affairs Jobs in Menlo Park, CA
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 Heart Failure (on-site)
- Pleasanton, CA (22 miles from Menlo Park, CA)
- 45+ days ago
- Pleasanton, CA (22 miles from Menlo Park, CA)
- 45+ days ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...
Senior Director, Regulatory Affairs (CMC)
- Brisbane, CA (20 miles from Menlo Park, CA)
- 3 days ago
- Brisbane, CA (20 miles from Menlo Park, CA)
- 3 days ago
Position Summary: Ultragenyx is seeking a highly motivated Senior Director, Regulatory Affairs CMC, who is a team builder and enjoys a fast-paced, dynamic work environment....
Associate Director, Regulatory Affairs
- Redwood City, CA (3 miles from Menlo Park, CA)
- 5 days ago
- Redwood City, CA (3 miles from Menlo Park, CA)
- 5 days ago
The Opportunity: The Associate Director of Regulatory Affairs will provide regulatory leadership to clinical development programs in oncology....
Director, Regulatory Affairs - Job ID: DRA
- Palo Alto, CA (2 miles from Menlo Park, CA)
- 7 days ago
- Palo Alto, CA (2 miles from Menlo Park, CA)
- 7 days ago
Director, Regulatory Affairs - Job ID: DRA Ascendis Pharma - 4.8 Palo Alto, CA Job Details Full-time $225,000 - $240,000 a year 15 hours ago Benefits Paid parental leave Health savings account AD&D...
Airworthiness and Regulatory Affairs Manager
- Palo Alto, CA (2 miles from Menlo Park, CA)
- 9 days ago
- Palo Alto, CA (2 miles from Menlo Park, CA)
- 9 days ago
About Wing: Wing offers drone delivery as a safe, fast, and sustainable solution for last mile logistics. Consumer appetites for on-demand services are increasing, but current delivery methods are...
Regulatory Affairs Manager Canada & Latin America Diabetes Care (on-site)
- Alameda, CA (22 miles from Menlo Park, CA)
- 10 days ago
- Alameda, CA (22 miles from Menlo Park, CA)
- 10 days ago
Alameda : 2901 Harbor Bay Parkway ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Awkward/forceful/repetitive (arms...
- South San Francisco, CA (18 miles from Menlo Park, CA)
- 11 days ago
- South San Francisco, CA (18 miles from Menlo Park, CA)
- 11 days ago
Position Overview: Sutro has a unique capability that enables new molecular entities to be designed using a hybrid of synthetic and recombinant technologies to create best in class therapeutics in...
Regulatory Affairs Manager Canada & Latin America Diabetes Care (on-site)
- Alameda, CA (22 miles from Menlo Park, CA)
- 11 days ago
- Alameda, CA (22 miles from Menlo Park, CA)
- 11 days ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...
Associate Director, Regulatory Affairs - Global Labeling
- Foster City, CA (8 miles from Menlo Park, CA)
- 21 days ago
- Foster City, CA (8 miles from Menlo Park, CA)
- 21 days ago
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop...
Commercial Regulatory Affairs Director
- Alameda, CA (22 miles from Menlo Park, CA)
- 22 days ago
- Alameda, CA (22 miles from Menlo Park, CA)
- 22 days ago
ESSENTIAL DUTIES AND RESPONSIBILITIES: Ensures compliance with all FDA regulations for prescription drug, advertising, and promotions, provides regulatory guidance for the development, review, approval...
Associate Director, Regulatory Affairs - Global Labeling
- Foster City, CA (8 miles from Menlo Park, CA)
- 23 days ago
- Foster City, CA (8 miles from Menlo Park, CA)
- 23 days ago
At Gilead, were creating a healthier world for all people. For more than 35 years, weve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies...
- South San Francisco, CA (18 miles from Menlo Park, CA)
- 29 days ago
- South San Francisco, CA (18 miles from Menlo Park, CA)
- 29 days ago
At Veracyte, we offer exciting career opportunities for those interested in joining a pioneering team that is committed to transforming cancer care for patients across the globe. Working at...
Sr Regulatory Affairs Manager, Abbott Ventures - Transcatheter Mitral Valve Replacement (on-site)
- Santa Clara, CA (14 miles from Menlo Park, CA)
- 29 days ago
- Santa Clara, CA (14 miles from Menlo Park, CA)
- 29 days ago
Working within a quality management system (QMS) with a clear understanding of the product lifecycle management and activities....
Senior Director, Regulatory Affairs CMC
- San Mateo, CA (10 miles from Menlo Park, CA)
- 30+ days ago
- San Mateo, CA (10 miles from Menlo Park, CA)
- 30+ days ago
General Description:** BeiGene is seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual leads biologics regulatory CMC team...
Senior Director, Regulatory Affairs Strategy and Compliance
- San Mateo, CA (10 miles from Menlo Park, CA)
- 30+ days ago
- San Mateo, CA (10 miles from Menlo Park, CA)
- 30+ days ago
General Description:** The Senior Director, Regulatory Affairs Strategy and Compliance is responsible for developing and implementing comprehensive regulatory strategies to ensure compliance with global...
Demographic Data for Menlo Park, CA
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Director of Regulatory Affairss in Menlo Park, CA 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
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