Regulatory Affairs Associate ( 1 year contract)

• Ensure local regulatory compliance through the preparation and submission of timely, high-quality documentation for labeling updates, license renewals, and other required applications.
• Monitor submission status and support timely responses to deficiency letters and regulatory authority requests, ensuring accurate documentation of all interactions.
• Maintain and update internal and external regulatory databases, providing relevant milestones and updates to cross-functional teams.
• Oversee the implementation of approved labeling into packaging materials, in compliance with local legislation and company SOPs.
• Collaborate with internal stakeholders to collect and validate information required for regulatory submissions, ensuring alignment with business needs.
• Ensure regulatory compliance of product registrations, labeling, and promotional materials, in line with local health authority requirements and company policies.
• Review labels, artwork, promotional materials for compliance.
• Maintain regulatory documentation, licensing, and filing systems. Key Working Relation: Ministry of Health, Marketing & Digital, Product Supply, Research and Development, Regulatory, Medical, Safety, Quality & Compliance Skills

• Educational background in a related field such as pharmacy, life sciences, or pharmaceutical.
• Strong understanding of regulatory requirements and processes
• Excellent communication for liaising with regulatory agencies, internal and external stakeholders.
• Attention to detail and accuracy in documentation and compliance procedures.
• Strong organization, communication, and stakeholder management skills.
• Analytical and problem-solving skills for resolving regulatory issues and challenges.
• Project management skills to coordinate regulatory activities and timelines effectively.
• Knowledge of relevant guidelines, and industry standards and policies and responsible countr

Bayer