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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for small molecule and biological products, with a strong focus on preparing regulatory dossiers and assessing compliance risks. Proficient in communicating regulatory issues and collaborating with stakeholders to achieve regulatory milestones throughout the product lifecycle.
Highest-signal resume keywords
Regulatory CMC ExperiencePharmaceutical Manufacturing KnowledgeScientific Information ReviewOral And Written Communication SkillsLeadership And Interpersonal Skills
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 CMC StrategiesRegulatory Dossier PreparationRisk AssessmentChange ManagementAnalytical TestingQuality AssuranceScientific Rationale AssessmentData PresentationInnovative Solution GenerationProject Management
Soft Skills
Effective CommunicationListening SkillsFlexibilityPrioritizationStakeholder Engagement
Industry Keywords
Biological ProductsPharmaceutical ResearchManufacturingTestingHealth Authority CompliancePost-Approval SupplementsAnnual ReportsRegistration RenewalsRegulatory MilestonesGlobal Regulatory Requirements
About the role
Key responsibilities & impact- Implement Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small molecule or biological products
- Prepare and review information required for development of regulatory CMC dossiers for commercial products
- Provide input to global product and project regulatory strategies by assessing CMC changes and identifying global regulatory requirements
- Critically evaluate supporting documentation for acceptability and potential risks
- Lead development, authoring, and review of CMC submission components and documentation for post-approval supplements, annual reports, registration renewals, and responses to health authority questions
- Liaise with Organon Manufacturing & Supply colleagues and external partners to support compliant change management
- Assess and communicate regulatory risks and propose mitigation strategies
- Deliver regulatory milestones for assigned products across the product lifecycle
- Identify and communicate potential regulatory issues to Organon Regulatory CMC management
Requirements
What you’ll need- Bachelor’s Degree in a science, engineering, or related field, including Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry, with at least 4 years of relevant experience; OR advanced degree (MS, MBA, Ph.D., PharmD) with at least 2 years of relevant experience
- Relevant experience including biological/pharmaceutical research, manufacturing, testing, or a related field
- Proficiency in English; additional language skills are a plus
- Experience reviewing scientific information to assess technical merits and suitability of scientific rationale
- Ability to ensure information is clearly presented and conclusions are adequately supported by data
- Demonstrated oral and written communication skills
- Ability to communicate issues succinctly and logically; strong listening skills
- Understanding of pharmaceutical manufacturing, analytical testing, and quality assurance
- Ability to generate innovative solutions and work with and communicate to key stakeholders
- Flexibility in responding to changing priorities or unexpected events
- Ability to handle multiple priorities and balance work to achieve business goals
- Demonstrated effective leadership, communication, and interpersonal skills
- Must be able to satisfy applicable travel and credentialing requirements, including associated vaccination prerequisites
- Valid driving license field is listed, but no requirement is specified
- Direct experience in Regulatory CMC is preferred
Benefits
Comp & perks- Retirement savings plan
- Paid vacation and holiday time
- Paid caregiver/parental and medical leave
- Health benefits including medical, prescription drug, dental, and vision coverage
- Flexible work arrangements: Flex Time, Hybrid