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    Associate Principal Scientist, Regulatory Affairs Chemistry, Manufacturing And Controls (Cmc)

    Organon
    7+ years
    $124,000.00 - $210,700.00
    Jersey City Plymouth Meeting
    10 Nov. 24, 2024
    Job Description
    Job Type: Full Time Remote Education: MS/MBA/Ph.D/PharmD/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Description: Associate Principal Scientist (Associate Director), Regulatory CMC

    Organization: Organon
    Location: Flexible Work Arrangements (Flex Time, Telecommuting)
    Travel: Up to 10%

    Position Overview

    The Associate Principal Scientist (Associate Director) is responsible for Regulatory Chemistry, Manufacturing, and Controls (CMC) activities for clinical-phase and market product registrations. This role ensures compliance with global regulations and oversees the regulatory CMC strategies for biological, biosimilar, and small molecule products, supporting Organon's focus on innovative women’s health solutions. The incumbent collaborates with internal teams and external partners, including contract organizations, to achieve regulatory and business goals.

    Key Responsibilities

    Strategic Leadership

    • Develop and execute Regulatory CMC strategies for late-stage development, commercial, and licensed products, ensuring compliance with global regulations and guidance.
    • Lead the preparation and authoring of regulatory submissions, including IND/CTA, NDA/BLA, and post-approval documentation.
    • Provide input for Health Authority engagement, including strategy, background packages, and participation in CMC-related meetings.

    Regulatory Compliance and Documentation

    • Ensure submissions meet regulatory requirements, timelines, and e-publishing standards.
    • Oversee quality and technical congruency of regulatory CMC content, ensuring accuracy and regulatory compliance.
    • Assess CMC changes during development and define global regulatory requirements while balancing risk and opportunity.

    Collaboration and Stakeholder Management

    • Partner with internal teams (Research & Development, Manufacturing & Supply, Business Development, and Commercial) and external partners to align strategies and deliverables.
    • Embed regulatory CMC activities into product development plans, providing a clear roadmap for approvals and robust supply chains.

    Risk and Issue Management

    • Identify, communicate, and escalate potential regulatory issues to Organon Regulatory CMC leadership.
    • Evaluate technical documentation for completeness and suitability, leveraging regulatory intelligence to address challenges effectively.

    Continuous Improvement and Leadership

    • Contribute to organizational initiatives and process improvements, focusing on efficiency and agility in regulatory CMC operations.
    • Provide mentorship and leadership to matrixed teams, ensuring alignment with project timelines and business objectives.

    Required Education, Experience, and Skills

    Education

    • Bachelor’s degree in a science, engineering, or related field (e.g., Pharmacy, Chemistry, Chemical Engineering, Biology, Microbiology, Molecular Biology, Biochemistry).
      • Experience Required: At least 7 years of relevant experience.
    • Advanced degree (MS, MBA, Ph.D., PharmD) preferred.
      • Experience Required: At least 5 years of relevant experience.

    Core Competencies

    • Regulatory Expertise: Strong understanding of global regulatory CMC guidelines and post-approval change management.
    • Technical Proficiency: Skilled in authoring and reviewing regulatory documentation, ensuring clarity and data-supported conclusions.
    • Communication Skills: Exceptional oral and written communication, with the ability to address complex issues succinctly.
    • Cross-Disciplinary Knowledge: Knowledge of pharmaceutical manufacturing, process development, analytical testing, and quality assurance.

    Leadership and Project Management

    • Proven ability to manage multiple projects, deliver on commitments, and meet timelines.
    • Demonstrated flexibility in addressing changing priorities and unexpected events.
    • Experience in leading teams and collaborating across multicultural and matrixed settings.

    Preferred Skills and Experience

    • Regulatory CMC Specialization: Direct experience with biologics, biosimilars, and device/combination products.
    • Technical Problem-Solving: Innovative approaches to complex regulatory challenges.
    • Advanced Communication Skills: Superior ability to communicate across diverse audiences and cultures.
    • Device Experience: Regulatory expertise in combination products and devices.

    About Organon

    Organon is a global leader in healthcare solutions, focused on women’s health and expanding access to trusted health products, biosimilars, and innovative therapeutics. We strive to create a better and healthier future, fostering an inclusive and collaborative environment where everyone can excel.

    Employment Details

    • Status: Regular
    • Relocation: Not available
    • Visa Sponsorship: Not available
    • Work Arrangements: Flex Time, Telecommuting

    Organon embraces diversity and equal opportunity, ensuring that all employees and applicants are treated equitably without regard to race, gender, age, or other protected characteristics.

    For more information about your rights under Equal Employment Opportunity, visit:

    • EEOC Poster
    • EEOC GINA Supplement

    Salary Range (US): $124,000 – $210,700
    Salary ranges vary by location.

    For additional information, visit Organon Careers.

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