Senior Regulatory Affairs Pharmacist

UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED; Singapore; On-site; SGD 80,000 - 100,000; Full time

Job summary

A leading company in regulatory affairs is seeking a registered Pharmacist to support various regulatory activities. The role encompasses preparing and submitting regulatory documents, ensuring compliance with guidelines, and liaising with authorities. Ideal candidates should possess 2-3 years of relevant experience and strong communication skills.

Qualifications

• Preferably at least 2-3 years of registration experience.
• Good knowledge on the HSA regulations.
• Detailed and organized.

Responsibilities

• Support regulatory activities including dossier preparation and submissions.
• Maintain and update regulatory documentation and records.
• Liaise with regulatory authorities to ensure compliance.

Skills

Self-motivated

Strong communication skills

IT literacy

Education

Registered Pharmacist with the Singapore Pharmacy Board

Job description

SINGAPOREAN AND PERMANENT RESIDENT ONLY

Key Responsibilities: -

• Support regulatory activities such as preparing, compiling, and submitting dossiers, ensuring completeness and accuracy of regulatory submissions.

• Handle applications for variations, changes and updates to dossier.

• Conduct regulatory review of new and existing products, including product labelling, advertising, and promotional materials to ensure compliance to the regulations.

• Maintain and update regulatory documentation and records.

• Liaise with and maintain positive relationship with regulatory authorities.

• Stay current with regulatory guidelines, regulations and disseminate relevant information within the company.

• Perform safety monitoring and reporting to regulatory authorities and product owners.

• Support and implementation of established quality assurance system, including product complaints and recalls.

• Support sales and marketing in all regulatory related areas, including product trainings.

  Requirements: -

• Preferably, registered Pharmacist with the Singapore Pharmacy Board.

• Preferably, at least 2-3 years of registration experience.

• Good knowledge on the HSA regulations.

• Self-motivated, committed, and able to handle multiple tasks at any time.

• Detailed and organized.

• Strong communication skills and IT literacy.