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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 submissions and assessing compliance with global regulatory requirements. Proven ability to communicate effectively with stakeholders and manage multiple priorities in a dynamic environment.
Highest-signal resume keywords
Regulatory Chemistry, Manufacturing & Controls (CMC)Regulatory Submission PreparationPharmaceutical ManufacturingAnalytical TestingQuality Assurance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Regulatory CMC Dossier PreparationBiological/Pharmaceutical ResearchTechnical Merits AssessmentChange Management ExecutionRisk Assessment and Mitigation
Soft Skills
Oral and Written CommunicationListening SkillsInterpersonal SkillsFlexibilityLeadership
Industry Keywords
PharmacyChemical EngineeringBiologyMicrobiologyVirologyMolecular BiologyBiochemistryStakeholder EngagementPost-Approval SupplementsHealth Authority Communication
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 regulatory CMC dossiers for commercial products
- Provide input to global product and project regulatory strategies
- Assess CMC changes, identify global regulatory requirements, and evaluate supporting documentation
- Lead development, authoring, and review of CMC submission components and documentation
- Support post-approval supplements, annual reports, registration renewals, and responses to health authority questions
- Liaise with Organon Manufacturing & Supply colleagues and external partners
- Support compliant execution of change management
- Assess and communicate potential 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 including biological/pharmaceutical research, manufacturing, testing, or a related field OR advanced degree (MS, MBA, Ph.D., PharmD) with at least 2 years of relevant experience in these areas
- 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 effectively with key stakeholders
- Flexibility in responding to changing priorities and unexpected events
- Capability to handle multiple priorities and balance work to achieve business goals
- Effective leadership, communication, and interpersonal skills
- Ability to satisfy applicable travel and credentialing requirements, including vaccination prerequisites
- Valid driving license is not specified as required
- No visa sponsorship
- US and PR residents only
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
- Hybrid work arrangements
- Flex time
- Employee status: Regular