FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Regulatory CMC strategy for small molecules, ensuring compliance with FDA, EMA, and ICH requirements while leading Module 3 preparation and Marketing Authorization Applications. Capable of identifying regulatory risks and aligning strategies with development and commercialization objectives in a global, cross-functional environment.
Highest-signal resume keywords
Regulatory CMC StrategyModule 3 PreparationMarketing Authorization ApplicationsFDA and EMA ComplianceSmall Molecule Expertise
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 CMCModule 3Marketing Authorization ApplicationsNDA SubmissionsRegulatory ComplianceICH RequirementsRisk Mitigation StrategiesScientific RobustnessPharmacyChemistry
Soft Skills
Strategic InputCross-Functional CollaborationNegotiation Approaches
Certifications & Qualifications
Master’s Degree in Pharmacy, Chemistry, Life Sciences, Biotechnology, or Pharmaceutical Sciences
Industry Keywords
Pharmaceutical IndustryGlobal Regulatory RequirementsInternational MarketsFDAEMAICHChinaJapanBrazilCanada
About the role
Key responsibilities & impact- Lead the global Regulatory CMC strategy for a small molecule product
- Support Marketing Authorization Applications
- Lead and review Module 3 preparation and submission activities
- Support interactions with FDA, EMA and other Health Authorities, including responses to questions
- Identify regulatory risks and define mitigation strategies
- Operate within a global and cross-functional matrix environment
- Align CMC regulatory strategies with development and commercialization objectives
- Coordinate with CMC, Quality, Manufacturing, Regulatory and Technical teams
- Ensure consistency, scientific robustness and regulatory compliance of submission content
- Provide strategic input on regulatory positioning and negotiation approaches
- Ensure compliance with applicable ICH and global regulatory requirements
Requirements
What you’ll need- Master’s degree or equivalent in Pharmacy, Chemistry, Life Sciences, Biotechnology, Pharmaceutical Sciences or a related scientific discipline
- Solid experience in Regulatory CMC within the pharmaceutical industry
- Strong expertise in small molecules
- Proven experience with Module 3 and global Marketing Authorization Applications / NDA submissions
- Strong knowledge of FDA, EMA and ICH requirements
- Experience with international markets such as China, Japan, Brazil and Canada is a plus
- Fluent English required
Benefits
Comp & perks- International network and collaborative work environment
- Talent development and skills-building opportunities
- Opportunity to work on a wide variety of high-value projects
- Collaboration with recognized experts
- Meaningful contribution to improving the patient journey
- Equal opportunities and commitment to a diverse, equitable, and inclusive workplace
- Employee experience focus