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Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in CMC Regulatory Affairs, including the development and submission of marketing authorizations and compliance with global regulations. Proven ability to lead regulatory strategies for biologic products and enhance cross-functional collaboration.
Highest-signal resume keywords
CMC Regulatory Affairs ExperienceGlobal CMC Regulatory RequirementsBiologic Products KnowledgeRegulatory Authority EngagementStrong Communication Skills
About the role
Key responsibilities & impact- Lead CMC regulatory strategies for assigned biologic products
- Support CMC development through early phase, submission, and post-market activities
- Assess changes and deviations for regulatory impact and filing requirements
- Review regulatory filings for compliance with applicable regulations and guidelines
- Support regulatory authority interactions, including meetings and information request responses
- Develop Working Instructions, SOPs, and Reviewer’s Guides to improve consistency
- Identify regulatory process gaps and recommend efficiency improvements
- Translate ambiguity into actionable steps and build alignment across teams
- Collaborate with Global Regulatory Affairs and CMC collaborators
- Support training activities and address technical or regulatory knowledge gaps
Requirements
What you’ll need- Bachelor’s degree with 6+ years, or advanced degree with 3+ years, in pharmaceutical, biotechnology, or Health Authority settings
- 2-4 years of CMC Regulatory Affairs experience with worldwide regulations
- Strong understanding of global CMC Regulatory Affairs requirements
- Experience delivering CMC sections of marketing authorizations, CTA/INDs, and post-approval submissions
- Experience supporting biologic products preferred
- Experience engaging with FDA or other regulatory authorities preferred
- Strong communication, negotiation, strategic thinking, and problem-solving skills
- Ability to build cross-functional partnerships, manage competing priorities, and deliver results in dynamic environments
- Ability to support training activities and proactively address technical or regulatory knowledge gaps
- Background checks may be conducted, including verification of identity, right to work, and educational qualifications
Benefits
Comp & perks- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical, dental, vision, life and disability insurance benefits
- Paid time off
- Family support benefits
- Reasonable accommodation during the recruitment process where required
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 Filing ReviewCMC Development SupportMarketing Authorization DeliveryCTA/IND Submission ExperienceRegulatory Impact Assessment
Soft Skills
Strategic ThinkingProblem-SolvingNegotiation SkillsCross-Functional Partnership BuildingDynamic Environment Adaptability
Tools & Technologies
SOP DevelopmentWorking Instructions CreationReviewer’s Guides Development
Industry Keywords
PharmaceuticalBiotechnologyHealth AuthorityRegulatory CompliancePost-Market Activities