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:

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.
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.
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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Regulatory Affairs Specialist - Project Management Role

Job Description

Position Overview:

Key Responsibilities:

Required Qualifications and Skills:

Additional Information:

Organon Overview:

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