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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Regulatory Affairs and Quality Assurance within the pharmaceutical or biotech industry, with a strong focus on cGMP and GLP compliance. Proficient in technical writing, validation protocols, and maintaining regulatory documentation to ensure adherence to FDA and EU standards.
Highest-signal resume keywords
Regulatory SubmissionsCGMP ComplianceTechnical WritingQuality AssuranceFDA Regulations
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory SubmissionsValidation ProtocolsTechnical DocumentationCGMP ComplianceGLP ConceptsSOP AuthoringAnalytical SkillsProblem-Solving SkillsComputer LiteracyQuality Control
Soft Skills
Strong Work EthicAttention to DetailInterpersonal SkillsOrganizational SkillsCommunication Skills
Tools & Technologies
MS OfficeSAP
Industry Keywords
FDAEU RegulationsQuality AssuranceRegulatory AffairsPharmaceutical IndustryBiotech IndustryComplianceValidation CAPAsInternal AuditsTechnical Submissions
About the role
Key responsibilities & impact- Write, review and approve submissions to the FDA and other regulatory agencies
- Coordinate completion of technical documentation required to meet submission timelines
- Review and approve validation IQ, OQ, PQ, CQ, FEQ, AMF and PV protocols and reports
- Perform compliance reviews of Validation CAPAs and verify action items are satisfactorily addressed
- Verify completeness and accuracy of information
- Interface with various groups to ensure complex technical submissions and FDA information requests are accurate and complete
- Participate in regulatory and internal inspections and audits
- Discuss findings directly with auditors and provide written responses as applicable
- Maintain current knowledge of FDA, EU and other regulatory agencies and industry standards
- Release approved regulatory changes in SAP for implementation in manufacturing
- Review and approve R&D stability and characterization protocols and final reports
- Provide scientific and technical advice regarding projects and validations
- Author and edit SOPs, License Specifications, regulatory submissions and other documents
- Provide regular status updates to senior management
- Maintain a quality presence to ensure compliance with regulatory requirements
Requirements
What you’ll need- Bachelor’s degree in the sciences or related field
- Minimum 5 years’ experience in Quality Assurance, Regulatory Affairs, Compliance, Quality Engineering or Quality Control in the pharmaceutical or biotech industry
- Strong emphasis on cGMP and GLP concepts
- Comprehensive knowledge and understanding of cGMPs, FDA, EU and other regulatory agency requirements, and industry guidelines
- Ability to work independently with minimum supervision
- Strong organizational, analytical, and problem-solving skills
- Ability to make structured decisions on a routine basis
- Proactive and results-oriented with strong attention to detail
- Strong work ethic and ability to exercise good judgment
- Ability to prioritize and manage multiple tasks to meet targeted deadlines
- Strong technical writing and interpersonal skills
- Excellent verbal and written communication skills
- Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
- Ability to provide regular status updates to senior management
- Ability to maintain a quality presence and ensure compliance with regulatory requirements
- Must be able to communicate information and ideas effectively and understand spoken and written information
- Ability to interact with diverse groups and handle sensitive information
- Ability to obtain consensus on issues
- Ability to lift and carry objects up to 25 lbs
- Ability to frequently drive to site locations
- Occasional travel within the United States
Benefits
Comp & perks- Up to 8% of the company bonus pool
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- PTO
- Paid holidays
- Up to 5% 401(K) match
- Tuition reimbursement
- Opportunities for professional growth and career progression
- Family-like culture