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    Regulatory Affairs Specialist - Project Management Role

    Organon
    2+ years
    Not Disclosed
    Istanbul
    10 Nov. 24, 2024
    Job Description
    Job Type: Full Time 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

    The job description you provided is for a Regulatory Affairs Specialist position at Organon, specifically on a one-year contract basis. Below is a breakdown of the key aspects of the role:

    Position Overview:

    • Reports to: Regulatory & PV Lead/Senior Regulatory Specialist.
    • Primary Objective: The role involves executing regulatory activities to get products to market according to company plans while ensuring compliance with local regulatory requirements and Organon’s policies.

    Key Responsibilities:

    1. Maintenance of Existing Products (60%):

      • Submit and follow up on labeling and quality-related variations.
      • Manage license renewals and ensure timely submissions of variations and GMP-related submissions.
      • Handle license transfers and ensure proper artwork control and approval in collaboration with the Labeling Coordinator.
      • Coordinate closely with local partners.

    2. Regulatory Compliance (25%):

      • Update and implement local regulatory procedures in alignment with regional policies.
      • Ensure full compliance with relevant legislation and company procedures.
      • Collaborate with local partners to ensure compliance across all regulatory activities.

    3. Shaping the Regulatory Environment (15%):

      • Share intelligence on competitive products, generics, and emerging regulations.
      • Interact with the Ministry of Health as needed.
      • Provide strategic advice to management and regional teams to accelerate regulatory approvals while maintaining compliance.

    Required Qualifications and Skills:

    • Education: Bachelor's degree in pharmacy (preferred), Chemistry, or Chemical Engineering.
    • Experience: Up to 2 years of experience in Regulatory Affairs or a similar position.
    • Language: English fluency is required.
    • Competencies:
      • Strategic thinking and proactive management.
      • Strong collaboration, communication, and negotiation skills.
      • Customer-oriented with a collaborative mindset.

    Additional Information:

    • Employee Status: Temporary (Fixed Term), for one year.
    • Travel Requirements: Must meet travel and credentialing requirements.
    • Location: The role involves working closely with both the global team and the local team in Turkey.
    • Relocation: No relocation support is provided.
    • VISA Sponsorship: Not mentioned.
    • Flexible Work Arrangements: Not specified.

    Organon Overview:

    • Organon is a global healthcare company with a focus on improving health outcomes, particularly for women and their families. They offer a diverse portfolio and emphasize women's health, biosimilars, and accessible health solutions.

    Let me know if you'd like help preparing a resume or cover letter for this position, or if you need more details on any part of the description!

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