About this role

This role involves developing and executing regulatory strategies for pharmaceutical products, managing CMC dossiers, and ensuring compliance with global regulations to facilitate product approval.

Key Responsibilities

Develop regulatory strategies
Manage CMC dossiers
Coordinate submissions
Lead risk assessments
Ensure compliance

Technical Overview

Focus on CMC regulatory processes, dossier preparation, global regulatory requirements, and lifecycle management for pharmaceutical products, especially in respiratory/inhalation fields.

Ideal Candidate

The ideal candidate is a mid-level regulatory scientist with at least 5 years of experience in pharmaceutical CMC, familiar with global regulatory requirements and dossier preparation, especially in respiratory or inhalation products.

Must-Have Skills

Experience in biological/pharmaceutical researchRegulatory CMC experienceKnowledge of global regulatory requirementsExperience with regulatory submissions (INDNDAMAA)Leadership in regulatory strategy development

Nice-to-Have Skills

Experience with respiratory/inhalation productsExperience with product in-licensingRegulatory inspection readinessCross-functional team leadership

Required Skills

CMCRegulatory AffairsPharmaceutical DevelopmentRegulatory StrategiesCMC DossiersINDCTANDAMAARisk AssessmentRegulatory SubmissionGlobal Regulatory RequirementsProduct Lifecycle ManagementBiological SciencesPharmacyChemical EngineeringBiologyMicrobiologyBiochemistry

Hard Skills

CMCRegulatory AffairsPharmaceutical DevelopmentRegulatory StrategiesCMC DossiersINDCTANDAMAARisk AssessmentRegulatory SubmissionGlobal Regulatory RequirementsProduct Lifecycle ManagementBiological SciencesPharmacyChemical EngineeringBiologyMicrobiologyBiochemistry

Soft Skills

Regulatory KnowledgeCommunicationLeadershipStrategic ThinkingCollaborationProblem-solving

Industry & Role

Industry Pharmaceuticals

Job Function Regulatory CMC Strategy and Submission Management

Keywords for Your Resume

CMCRegulatory AffairsPharmaceutical DevelopmentRegulatory StrategiesCMC DossiersINDCTANDAMAARisk AssessmentRegulatory SubmissionGlobal Regulatory RequirementsProduct Lifecycle ManagementBiological SciencesPharmacyChemical EngineeringBiologyMicrobiologyBiochemistry

Deal Breakers

Less than 5 years of relevant experience, No experience with regulatory submissions, Lack of pharmaceutical research background, No experience in biological sciences

Associate Principal Scientist (Assoc. Director), Regulatory Affairs - CMC

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