Regulatory Pharmacist

PHARMAZEN MEDICALS PTE LTD; Singapore; On-site; SGD 50,000 - 90,000; Full time

Job summary

A pharmaceutical company in Singapore seeks a Regulatory Affairs professional to assist with regulatory filings, ensure compliance with local regulations, and collaborate with teams across R&D, clinical affairs, and marketing. Candidates must hold a Degree in Pharmacy, be registered with the Singapore Pharmacy Board, and possess strong organizational and communication skills. This role involves maintaining regulatory records and ensuring that all processes comply with legal requirements.

Qualifications

• Degree in Pharmacy required.
• Registered with the Singapore Pharmacy Board.
• Meticulous and well-organized.
• Good communications skills.
• Able to work independently.
• Ability to meet deadlines.
• Proficient in MS Office.

Responsibilities

• Assist in preparing and submitting regulatory filings for pharmaceutical drugs.
• Support investigation of regulatory compliance gaps.
• Maintain and update regulatory files and records.
• Collaborate with cross-functional teams to support regulatory and QA objectives.

Skills

Meticulous and well-organized

Good communication skills

Ability to work independently

Proficient in MS Office

Education

Degree in Pharmacy

Job description

Job Description & Requirements

Key Responsibilities :

• Assist in preparing and submitting regulatory filings and documentation for pharmaceutical drugs.
• Support investigation of regulatory compliance gaps with gap remediation plan development and implementation thereafter.
• Determine regulatory relevance and perform variation assessments.
• Maintain and update regulatory files and records as required.
• Ensures compliance with local regulations, corporate policies, and procedures
• Collaborate with cross-functional overseas teams including R&D, clinical affairs, and marketing to support regulatory and QA objectives.
• Ensure that all sales and supply of medicinal products comply with legal requirements:Records pertaining to all phases of drug receipt, supply, storage and distribution are maintained as required by the company and/or legal authorities.
  Performs inspections of drug storage area.

Qualifications & requirements:

• Degree in Pharmacy
• Registered with the Singapore Pharmacy Board
• Meticulous and well-organized
• Good communications skills
• Able to work independently
• Ability to meet deadlines
• Proficient in MS Office