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    Regulatory Affairs Manager

    Organon
    5+ years
    Not Disclosed
    Bangkok
    10 Nov. 24, 2024
    Job Description
    Job Type: Full Time Remote Education: 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: RAaPV Senior Specialist

    Organization: Organon
    Location: Remote/Global
    Travel: Limited

    Position Overview

    The Regulatory Affairs and Pharmacovigilance (RAaPV) Senior Specialist is responsible for managing all regulatory submissions and ensuring compliance with local laws, regulations, and company procedures. The role involves supporting product registrations, maintaining authorized product portfolios, and driving regulatory strategies to ensure alignment with market requirements. This position also contributes to process improvements, risk mitigation, and supply continuity while supporting PV (Pharmacovigilance) activities as assigned.

    Key Responsibilities

    Regulatory Submissions & Strategy

    • Develop and execute product registration plans, aligning with cross-functional teams.
    • Manage and submit post-market regulatory dossiers, including variations, renewals, GMP clearance, site transfers, and supplemental marketing authorizations.
    • Maintain regulatory documents in compliance with company policies and local requirements.

    Compliance & Quality Assurance

    • Ensure all activities adhere to local and global SOPs. Report and address compliance deviations through CAPAs.
    • Support audits and regulatory inspections, ensuring readiness and accurate documentation.

    Process Improvement

    • Identify gaps in regulatory processes and collaborate with stakeholders to implement solutions.
    • Improve local procedures to align with global standards, ensuring efficiency and effectiveness.

    Pharmacovigilance Support

    • Assist with PV activities, including supporting the local PV responsible person and contributing to regional PV unit collaborations.
    • Ensure compliance with regulatory requirements for drug safety and adverse event reporting.

    Cross-functional Collaboration

    • Coordinate with internal and external stakeholders to ensure timely, high-quality submissions.
    • Actively contribute to regulatory association working groups and regulatory projects.

    Documentation & Systems Maintenance

    • Archive regulatory dossiers, maintain internal systems, and support label updates and artwork maintenance.
    • Respond to agency requests, including post-marketing sample submissions.

    Competencies

    Inspires Growth

    • Drives skill development and champions change to align with business needs.

    Delivers with Accountability

    • Manages priorities effectively, drives compliance, and mitigates risks to achieve quality outcomes.

    Innovates with Agility

    • Introduces creative solutions to complex problems while aligning stakeholders.

    Makes Connections

    • Builds effective networks and partnerships to achieve regulatory goals.

    Communicates with Optimism & Authenticity

    • Clearly articulates strategies and decisions while demonstrating empathy and strong communication skills.

    Activates Belonging

    • Reinforces inclusivity in talent development and decision-making processes.

    Required Education, Experience, and Skills

    Education:

    • Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Health Sciences, or related field.
    • Advanced degree preferred.

    Experience:

    • Minimum 5 years of experience in regulatory affairs and/or CMC.
    • Strong understanding of ASEAN regulations (preferred) and regional regulatory requirements.

    Skills:

    • Proficient in regulatory and business strategies for product portfolio management.
    • Excellent time management, organizational, and communication skills.
    • Proven ability to work independently and collaboratively across markets.
    • Strong negotiation and stakeholder management skills.

    About Organon

    Organon is a global healthcare company dedicated to improving lives with a focus on women’s health, biosimilars, and innovative products. We are committed to fostering a diverse and inclusive workplace that drives meaningful impact for our customers and communities.

    Employment Details

    • Status: Regular
    • Relocation Assistance: Not available
    • Visa Sponsorship: Not available
    • Flexible Work Arrangements: Remote options available

    Organon values diversity and inclusivity, encouraging applications from candidates of all backgrounds.

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