Regulatory Affairs Consultant (Part-Time / Pharma MNC)

at  Integrity Partners Pte Ltd

REQUIREMENTS

• Degree in Pharmacy or a related field.
• Demonstrate proficiency in navigating Singapore’s regulatory landscape and preparing submissions for the local regulatory authority.
• Possess in-depth understanding and expertise in the regulatory requirements specific to biologics.
• Experience with post-marketing surveillance and quality management will be advantageous.
  Note: This is a part-time position (2 to 3 working days per week) for a pharmaceutical MNC.

POSITION OVERVIEW

• Ensure the accuracy and completeness of regulatory dossiers before submission to regulatory agencies, with a focus on Singapore.
• Maintain effective communication with internal teams and external regulatory authorities to address inquiries and ensure compliance with regulations.
• Provide valuable recommendations on regulatory strategies to streamline approval processes and accelerate product development while adhering to regulatory standards.
• Oversee all regulatory tasks related to biologics submissions, ensuring timely completion and compliance with relevant guidelines.

Please refer the Job description for details