Summary:

The Medicine Registration Specialist is responsible for the preparation and submission of regulatory dossiers for new drug applications and variations to the Health Sciences Authority (HSA) in Singapore. This role ensures that all regulatory activities are conducted in compliance with local and international regulations and guidelines.

Responsibilities:

• Dossier Preparation and Submission:
  • Prepare, review, and compile high-quality regulatory dossiers for new drug applications (NDAs), variations, renewals, and other regulatory submissions.
  • Ensure that dossiers are accurate, complete, and compliant with HSA requirements and relevant guidelines.
  • Coordinate with cross-functional teams (e.g., clinical, quality, manufacturing) to gather necessary data and documentation.
  • Submit dossiers electronically through the appropriate HSA portals.
• Regulatory Communication and Liaison:
  • Act as the primary point of contact with HSA on all regulatory matters related to assigned products.
  • Respond to HSA queries in a timely and professional manner.
  • Maintain up-to-date knowledge of regulatory requirements and guidelines.
  • Attend meetings and teleconferences with HSA as required.
• Regulatory Intelligence:
  • Monitor regulatory landscape and emerging trends in Singapore and the region.
  • Keep abreast of changes in regulations and guidelines that may impact assigned products.
  • Share regulatory intelligence with relevant internal stakeholders.
• Regulatory Compliance:
  • Ensure compliance with all applicable regulations and guidelines throughout the product lifecycle.
  • Maintain accurate and up-to-date regulatory records.
  • Conduct periodic internal audits to assess regulatory compliance.
• Additional Responsibilities:
  • Support other regulatory activities as needed, such as product labeling, advertising, and pharmacovigilance.
  • Participate in internal and external training programs to enhance regulatory knowledge and skills.

Qualifications:

• Bachelor's degree in pharmacy, life sciences, or a related field.
• Minimum 2 years of experience in regulatory affairs, preferably in the pharmaceutical industry.
• Strong knowledge of Singaporean and international regulatory requirements and guidelines.
• Excellent written and verbal communication skills.
• Strong attention to detail and organizational skills.
• Ability to work independently and as part of a team.

Desired Skills:

• Experience with electronic Common Technical Document (eCTD) submissions.
• Experience with regulatory project management.

• Proficiency in relevant software applications (e.g., Microsoft Office Suite).

• Looking for candidates available to work:
  • Monday: Morning, Afternoon
  • Tuesday: Morning, Afternoon
  • Wednesday: Morning, Afternoon
  • Thursday: Morning, Afternoon
  • Friday: Morning, Afternoon
• 1 year of relevant work experience required for this role
• Working rights required for this role
• Expected start date for role: 01 August 2024
• Expected salary: $3,500 per month