Regulatory Affairs Executive - JL

Position: Regulatory Affairs Executive (1 Year Renewable Contract) (Job ID: 20394)

• Pharmaceutical company

• Clarke Quay MRT

• Basic Salary (Up to $4,500) + Completion Bonus

Job Description:

1) Regulatory Affairs

. Manage the life cycle of the existing product portfolio in Singapore and Malaysia, while supporting regulatory compliance and continuity of product supply.
. Prepare, compile, review and submit high-quality registration dossiers to obtain timely regulatory approvals and maintain existing product registrations and licences in Singapore and Malaysia.
. Manage regulatory activities relating to new product registrations, renewals, variations, change notifications and other post approval commitments.
. Review product change requests, assess their regulatory impact and recommend appropriate regulatory actions, submission pathways and implementation timelines.
. Manage labelling changes, safety updates, artwork development and approval of packaging material components in accordance with applicable regulatory requirements and company procedures.
. Review proposed product labelling and packaging materials to ensure compliance with approved product information, product branding, global or regional standards and applicable local requirements.
. Track submission progress, maintain accurate regulatory records and manage responses to health authority queries within the required timelines.
. Liaise with the Health Sciences Authority, National Pharmaceutical Regulatory Agency and other relevant authorities, as applicable, on regulatory submissions, queries and commitments.
. Monitor changes in regulatory requirements and provide relevant regulatory intelligence and impact assessments to local, regional and global stakeholders.
. Provide regulatory input and support the development and implementation of regulatory strategies for Singapore and Malaysia.
. Work closely with Supply Chain, Commercial, Medical, Pharmacovigilance, Quality and other relevant functions to support product launches, product changes and continuity of supply.
. Maintain accurate and current regulatory databases, submission trackers, product registration records and regulatory documentation.
. Support the development, review, implementation and maintenance of applicable regulatory procedures, work instructions and training materials.
. Identify opportunities to improve regulatory processes, documentation quality and submission efficiency while maintaining compliance with applicable requirements.

2) Quality Assurance/Quality Management

The following responsibilities apply if the employee is eligible and formally appointed as the Responsible Person for the company's Therapeutic Products Importer's Licence and Wholesaler's Licence:

. Serve as the company's Responsible Person for the Therapeutic Products Importer's Licence and Wholesaler's Licence and fulfil the responsibilities associated with the appointment.
. Oversee local Good Distribution Practice operational quality activities, including product release, product hold, product return, product recall and other product disposition activities, as applicable.
. Ensure that products are imported, stored and distributed in accordance with applicable licence conditions, Good Distribution Practice requirements and company procedures.
. Support or lead inspections conducted by the health authority and coordinate the preparation, follow up and closure of inspection observations.
. Plan and perform Good Distribution Practice self-inspections and ensure that identified actions are documented, monitored and completed within the agreed timelines.
. Support the management of deviations, product complaints, corrective and preventive actions and other quality matters, where applicable.
. Support oversight of distributors, logistics service providers and other relevant third parties to ensure compliance with applicable quality agreements and Good Distribution Practice requirements.
. Support the preparation, review and maintenance of quality agreements relating to importation, storage and distribution activities.
. Escalate significant quality issues promptly and support appropriate investigation, risk assessment and corrective actions.

3) Others

. Review promotional and non-promotional materials to ensure alignment with approved product information, applicable regulatory requirements and company procedures.
. Collaborate effectively with cross functional stakeholders, regional and global teams, external partners and service providers to ensure consistent compliance and timely delivery of regulatory and quality activities.
. Provide regulatory support for Malaysia activities and work closely with the Malaysia regulatory team to ensure timely submissions, responses and implementation of approved changes.
. Support regulatory and quality audits and inspections, including preparation of requested documentation and follow up of resulting actions.
. Guide and coach junior team members on regulatory requirements, company procedures, documentation quality and the execution of regulatory activities.
. Support the onboarding and training of new team members and contribute to knowledge sharing across the Singapore and Malaysia teams.
. Perform other regulatory and quality related duties assigned based on business needs and the employee's qualifications and authorised responsibilities.

Job Requirements:

MUST HAVE

. Bachelor's degree in pharmacy, Pharmaceutical Science, Life Sciences or another relevant discipline.
. At least 2 years of Regulatory Affairs experience within the Singapore pharmaceutical industry.
. Demonstrated experience in preparing and managing regulatory submissions and post approval activities in Singapore.
. Comprehensive understanding of regulatory requirements and the potential impact of regulatory activities and product changes on product registrations, supply, labelling and related business processes.
. Experience in managing product life cycle activities, including variations, renewals, change assessments, labelling updates and health authority queries.
. Ability to independently manage multiple regulatory activities and deliverables within agreed timelines.

Preferred Qualifications and Experience

. Bachelor's degree in pharmacy
. Registered pharmacist with the Singapore Pharmacy Council and eligible to be appointed as the Responsible Person for the company's Therapeutic Products Importer's Licence and Wholesaler's Licence.
. Regulatory Affairs experience within the Malaysia pharmaceutical industry, including familiarity with National Pharmaceutical Regulatory Agency requirements.
. Experience supporting regulatory activities across both Singapore and Malaysia.
. Experience with different product types, such as chemical drugs, biologics and drug device combination products.
. Knowledge of Good Distribution Practice requirements and experience supporting quality operations, health authority inspections or self-inspections.

Interested applicants please send your resume to [Confidential Information] with email subject header Job Application for Regulatory Affairs Executive (Contract) (Job ID: 20394).

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