Senior Regulatory Affairs Specialist

Barrington James; Singapore; Presencial; SGD 89.000 - 112.000; Jornada completa

Descripción de la vacante

Barrington James is recruiting for a Senior Regulatory Affairs Specialist to lead regulatory, medical affairs and quality activities in Singapore on a 6-month maternity cover.

Based in Singapore, you will manage new product registrations, variations, advertising compliance, pharmacovigilance, and QA interfaces with regional teams, ensuring full regulatory compliance and timely submissions.

Formación

• Minimum 5 years pharmaceutical industry experience in Singapore or equivalent.
• Relevant degree with strong pharmacology/pharmaceutical chemistry knowledge.

Responsabilidades

• Lead regulatory affairs activities for Singapore and ensure regulatory compliance.
• Manage new product registrations, variations and notifications for SG.
• Review and approve promotional materials for regulatory and medical compliance.
• Oversee pharmacovigilance reporting and quarterly adverse event compilation.
• Coordinate quality assurance activities and GDP regulatory compliance.

Conocimientos

Regulatory Affairs

Project Management

Singapore regulatory knowledge

Quality Assurance

Educación

Pharmacy, medical or science degree

Descripción del empleo

Role: Senior Regulatory Affairs Specialist

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 Activities

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)

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