About this role
Senior regulatory affairs role supporting biologics and oncology programs, developing global regulatory strategies, and managing submissions for market approval.
Key Responsibilities
- Develop global regulatory strategies
- Manage regulatory submissions
- Coordinate with health authorities
- Support clinical development plans
- Ensure compliance with international regulations
Technical Overview
Focus on global regulatory landscape, including FDA, EMA, MHRA, PMDA, with expertise in biologics, ATMPs, and clinical trial regulations.
Ideal Candidate
The ideal candidate is a senior regulatory affairs expert with over 10 years of experience in biologics and oncology, skilled in developing global regulatory strategies and managing complex submissions across major markets.
Must-Have Skills
Extensive experience with global regulatory strategiesKnowledge of FDAEMAMHRAPMDA regulationsExperience with biologics and oncology productsFamiliarity with advanced therapy medicinal products (ATMPs)Experience with regulatory submissions and interactions
Nice-to-Have Skills
Experience with clinical trial regulationExperience with international health authoritiesKnowledge of oncology product development
Tools & Platforms
Regulatory Submission PlatformsClinical Trial Management Systems
Required Skills
Regulatory StrategyClinical DevelopmentMarketing AuthorizationPost-Approval MaintenanceINDsCTAsOrphan Drug DesignationsPediatric Study PlansBreakthrough TherapyPRIMEInnovation Passport
Hard Skills
Regulatory StrategyClinical DevelopmentMarketing AuthorizationPost-Approval MaintenanceRegulatory SubmissionsFDAEMAMHRAPMDABiologicsOncologyAdvanced Therapy Medicinal ProductsRegulatory AffairsGlobal Regulatory LandscapeINDsCTAsOrphan Drug DesignationsPediatric Study PlansBreakthrough TherapyPRIMEInnovation Passport
Soft Skills
Strategic ThinkingCommunicationRegulatory KnowledgeCross-functional CollaborationProblem-solvingAttention to Detail
Keywords for Your Resume
Regulatory StrategyClinical DevelopmentMarketing AuthorizationPost-Approval MaintenanceRegulatory SubmissionsFDAEMAMHRAPMDABiologicsOncologyAdvanced Therapy Medicinal ProductsINDsCTAsOrphan Drug DesignationsPediatric Study PlansBreakthrough TherapyPRIMEInnovation Passport
Deal Breakers
Lack of experience with FDA, EMA, or PMDA regulations, Less than 10 years in regulatory affairs, No experience with biologics or oncology products, Unfamiliarity with global regulatory processes
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