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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Regulatory CMC strategies for small molecule and biological products, with a strong focus on lifecycle management, regulatory submissions, and risk assessment. Proven ability to lead cross-functional teams and communicate effectively in multicultural environments.
Highest-signal resume keywords
Regulatory CMC Strategy DevelopmentCMC Dossier Preparation and SubmissionLifecycle Management ExperienceLeadership and Team ManagementRisk Assessment and Mitigation
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 CMCCMC Submission Components DevelopmentBiological/Pharmaceutical ResearchManufacturing KnowledgeAnalytical SkillsQuality Assurance UnderstandingScientific Information ReviewProject Regulatory Strategy ExecutionPost-Approval Lifecycle ManagementChange Management
Soft Skills
Effective CommunicationInterpersonal SkillsNegotiation SkillsFlexibilityLeadership
Industry Keywords
Biological ProductsPharmaceutical ProductsRegulatory SubmissionsHealth Authority ComplianceDue Diligence ReviewsRegistration RenewalsMulticultural SettingsInnovative SolutionsTravel RequirementsCredentialing Requirements
About the role
Key responsibilities & impact- Develop and implement Regulatory CMC strategies for assigned small molecule or biological products
- Lead preparation and submission of CMC dossiers for lifecycle maintenance submissions, original registrations, and post-approval changes
- Serve as CMC Product Lead and deliver regulatory milestones throughout the product lifecycle
- Develop and execute global product and project regulatory strategies
- Assess CMC changes, global regulatory requirements, supporting documentation, and potential risks
- Lead development, authoring, and review of CMC submission components
- Support post-approval supplements, annual reports, registration renewals, and responses to health authority questions
- Provide regulatory leadership for product in-license/due diligence reviews, divestments, and withdrawals
- Collaborate with Manufacturing & Supply colleagues and external partners on compliant change management
- Manage CMC documentation and regulatory submissions
- Assess and communicate regulatory risks and propose mitigation strategies
- Identify, communicate, and escalate regulatory issues to Regulatory CMC management
- May manage 1 to 2 individual contributors and/or outsourcing partners
- Support project team goals and organizational initiatives as needed
Requirements
What you’ll need- Bachelor’s degree in a science, engineering, or related field with at least 7 years of relevant experience, or an advanced degree (MS, MBA, Ph.D., PharmD) with at least 4 years of relevant experience
- Relevant experience including biological/pharmaceutical research, manufacturing, testing, or a related field
- Proficiency in English
- Proven experience critically reviewing detailed scientific information and assessing technical merits and scientific rationale
- Superior oral and written communication skills in multicultural settings
- Understanding of related fields such as manufacturing, analytical, and quality assurance
- Ability to generate innovative solutions to complex regulatory problems
- Flexibility in responding to changing priorities or unexpected events
- Effective leadership, communication, interpersonal, and negotiating skills
- Ability to lead direct or matrixed colleagues to deliver business commitments and project timelines
- Regulatory CMC post-approval lifecycle management experience preferred
- Must be a US or Puerto Rico resident
- No visa sponsorship available
- Ability to satisfy applicable travel and credentialing requirements, including vaccination prerequisites
- Valid driving license not specified as required
Benefits
Comp & perks- Retirement savings plan
- Paid vacation and holiday time
- Paid caregiver/parental and medical leave
- Medical, prescription drug, dental, and vision coverage
- Flex Time
- Hybrid work arrangement