Regulatory Affairs Associate

Job Main Purpose:

Primarily focused on regulatory compliance and meeting local regulatory milestones within the Bayer’s portfolios in Malaysia and Brunei. Overseeing documentation and archiving systems to ensure alignment with country regulations and internal Standard Operating Procedures (SOPs). This role involves assisting in the preparation and submission of regulatory documents, managing product lifecycle milestones, and maintaining up-to-date knowledge of regulatory requirements and industry standards.

Your Role & Responsibilities:

• Regulatory Submissions: Assist in preparing and submitting regulatory applications for product approvals, license renewals, and labeling changes to regulatory authorities.
• Documentation and Compliance: Ensure the accuracy and completeness of regulatory documentation, including product registrations, promotional materials, and labeling changes, in accordance with local and international regulations.
• Regulatory Tracking: Maintain and update internal regulatory tracking systems to ensure timely completion of regulatory milestones and submissions.
• Communication: Serve as a point of contact with regulatory agencies, stakeholders, and other departments to provide status updates on submissions and to respond to inquiries or requests for additional information.
• Regulatory Research: Assist in researching regulatory guidelines, industry standards, and market requirements to support regulatory activities and ensure compliance with current regulations.
• Product Lifecycle Support: Monitor the lifecycle of products to ensure ongoing compliance with regulations, including post-market surveillance, renewals, and updates to product dossiers.
• Cross-Functional Collaboration: Work closely with cross-functional teams, such as Medical Affairs, Quality Assurance, and Commercial teams, to ensure compliance in regulatory submissions and promotional activities.
• Regulatory Reporting: Contribute to the preparation of regulatory reports and regulatory filings for new product launches and ongoing regulatory matters.

Your Key Skills & Qualifications:

• Education: Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
• Experience: Minimum of 1 year of experience in Regulatory Affairs, ideally in the pharmaceutical or consumer health industry. Strong understanding of local and international regulatory requirements and processes
• Communication Skills: Excellent written and verbal communication skills for preparing documents, reports, and engaging with stakeholders.
• Attention to Detail: Strong attention to detail and accuracy in regulatory documentation and processes.
• Problem-Solving: Analytical and problem-solving skills for addressing regulatory issues and challenges.
• Time Management: Strong organizational skills with the ability to manage multiple tasks and meet deadlines.