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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 with a focus on CMC, including the development and execution of regulatory strategies, preparation of regulatory filings, and compliance with ICH guidelines and GMP/GCP requirements. Proven ability to collaborate with cross-functional teams and manage post-market supplements and facility registrations effectively.
Highest-signal resume keywords
Regulatory Affairs ExperienceRegulatory CMC ExpertiseICH Guidelines KnowledgeRegulatory Dossier PreparationPharmaceutical Industry Experience
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 Strategy DevelopmentRegulatory Filing PreparationPost-Approval VariationsImpact AssessmentsAnnual Reports MaintenanceChange Management SupportQuality Control (QC)Quality Assurance (QA)Common Technical Document (CTD) StructureFacility Registrations
Soft Skills
Cross-Functional CollaborationEffective CommunicationProblem-Solving
Industry Keywords
Pharmaceutical IndustryBiotechnology IndustryGMP RequirementsGCP RequirementsRegulatory ComplianceAgency InteractionsDeviation ManagementPDT Variation Master Plan
About the role
Key responsibilities & impact- Develop strategy and execute site-specific aspects of CMC post-market supplements and facility registrations
- Interface with site functions to coordinate preparation of regulatory filings
- Identify issues and factors that may implicate regulatory strategy or activity
- Provide impact assessments for deviations with input from CMC Product teams and the CMC Region representative
- Define minimum regulatory filing requirements for post-approval programs
- Provide regulatory strategy through development of MASP and/or GIRS
- Develop post-approval variations
- Maintain applications, including Annual Reports, Distribution Reports, and Annual Stability updates
- Maintain product compliance through regulatory filings, activities, and regulatory commitments
- Support Change Management activities
- Respond to regulatory agency questions
- Facilitate agency interactions, including meeting preparation, meetings, and briefing documents
- Liaise with development, operations, and commercial functions to align global regulatory strategies, timing, execution, and plans
- Contribute to the PDT’s Variation Master Plan
- Participate as an active member of cross-functional teams
Requirements
What you’ll need- Doctorate degree OR Master’s degree and 2 years of Regulatory Affairs experience OR Bachelor’s degree and 4 years of Regulatory Affairs experience OR Associate’s degree and 8 years of Regulatory Affairs experience OR High school diploma / GED and 10 years of Regulatory Affairs experience
- Degree in a life sciences discipline, or equivalent relevant experience
- Experience in Regulatory CMC within the pharmaceutical or biotechnology industry
- Working knowledge of ICH guidelines and current GMP and GCP requirements
- Experience preparing and compiling regulatory dossiers in accordance with ICH guidelines and Common Technical Document (CTD) structure
- Experience in pharmaceutical or biotechnology manufacturing, Quality Control (QC), or Quality Assurance (QA)
- Sponsorship for this role is not guaranteed
Benefits
Comp & perks- A comprehensive employee benefits package
- Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
- Financial plans with opportunities to save towards retirement or other goals
- Career development opportunities
- Reasonable accommodation for individuals with disabilities