Regulatory Affairs Associate

MAIN PURPOSE: 

Primarily focused on regulatory compliance and milestone delivery for the Bayer portfolios in Malaysia & Brunei. Responsible for ensuring regulatory compliance and meeting local regulatory milestones for a designated range of products within the Bayer portfolio. Oversight of electronic and paper archiving systems to ensure alignment with country regulations and internal standard operating procedures (SOPs). Effective management of product lifecycles, including updating regulatory databases/tracking documents and facilitating communication with stakeholders. Uphold compliance with all relevant regulatory and corporate standards for products throughout their lifecycle. 

YOUR KEY ROLE & RESPONSIBILITIES:

• 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

YOUR KEY SKILLS & QUALIFICATIONS:

• 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