Senior Regulatory Affairs Specialist

Role: Senior Regulatory Affairs Specialist

Location: Singapore

Type: 6 Months Maternity Cover

To lead and manage all regulatory, medical affairs and quality related activities and ensure full regulatory compliance for Singapore. The role partners closely with Country leadership and Regional/Group Regulatory Affairs (RA) to deliver compliant submissions, support promotional/medical compliance activities and coordinate quality/GxP interfaces with regional functions (QA, SC).

Key Accountabilities & Performance Indicators

• Perform Regulatory Affairs Activities (SG)
• Competence with therapeutic products, traditional medicines, cosmetic and food products related regulations and guidelines.
• Manage new product registrations, variations and notifications, as applicable, in line with company strategy to ensure compliance with local regulatory and company requirements.
• Manage advertisement and sales promotion permits submission and ensure compliance.
• Review and approve artwork in Veeva system, coordinate with Supply Chain and communicate with SG Commercial for the changes and implementation.

Perform Regulatory Affairs Activities

• Manage new product registrations, variations, notifications and renewal via third-party distributor
• Coordinate with Supply Chain to ensure artwork compliance and to apply exemption request if necessary
• Review & approve promotional materials and external communications (HCPs, customers, consumers) for regulatory and medical compliance with local requirements and applicable industry codes
• Manage the pharmacovigilance reporting in Singapore, in accordance with the company’s SOPs and HSA regulatory requirements, compile quarterly adverse event from HSA database.

Perform Quality Assurance

• Ensuring that GDP regulatory compliance sis implemented and maintained for the company’s therapeutic products wholesaler and importer licenses.
• Participate in internal audit and conduct mock recall where applicable
• Manage product redressing via third party distributor, including drafting & reviewing Redressing Instructions
• Oversee product complaints, product return in Singapore and support Commercial Quality.

Qualifications

Qualifications, Skills and Experience

• Minimum 4-5 years’ pharmaceutical industry experience in Singapore (Essential)
• Pharmacy, medical or relevant science degree with good pharmacological/ pharmaceutical chemistry/ clinical knowledge (Essential)
• Current SG pharmacist licence/registration (Singapore Pharmacy Council) (preferable)

Skills & Experience

• Minimum 5 years pharmaceutical industry experience
• Experienced with the regulatory environment in SG and understands advertisement & sales promotion regulations and controls
• Familiarity with traditional medicines, health supplement, cosmetic, medical device and food product regulation is a bonus
• Strong project management and organisational skills