Regulatory Affairs Manager, Asia

embecta; Johor Bahru; In loco; MYR 120.000 - 160.000; Tempo pieno

Descrizione del lavoro

embecta is seeking a Regulatory Affairs Manager to develop and execute regulatory strategies for Singapore, Distributor Markets and Assigned Markets. You will lead local RA resources, coordinate with distributors, license holders and consultants, and collaborate with Trade Compliance, Supply Chain and Quality to secure timely registrations.

You will manage registration activities, maintain licenses, track timelines, and ensure compliance with global regulatory requirements.

Competenze

• B.A degree in Pharmaceutical, Engineering, Chemistry, Life Science or other.

Mansioni

• Assess registration requirements and timelines for required markets.
• Use, promote and maintain the registration tracker for the countries they are responsible for.
• Manage registration activities through local providers. Assist with the preparation of registration dossiers and manage submissions by maintaining close collaboration with distributor regulatory teams and internal regulatory departments.
• Maintain licenses and undertake renewal activity to ensure continuity.
• Maintain the embecta eRIM (embecta Regulatory Information System).
• Triage or complete fresh ticket information requests.
• Manage stakeholder expectations including local business managers and to be clear about RA requirements and position.
• Provide tender support, RA information to local markets.
• Work with the PMS team on Vigilance reporting to competent authorities. Triaging complaints is undertaken by the QA team.
• Provide input to Quality and Supply chain for any Field Actions in accordance with country and global company regulatory requirements.
• To develop and maintain clear and concise project management activities to enable clear understanding of registration activities, actions, progress and timelines.
• Provide regulatory input for advertising and promotional material.
• Review Regulatory Intelligence material as required and identify any actions we may need to take, for example a change to regulatory registration requirements.
• Support regional and international project activities and information requests.
• Develops and executes regulatory strategies to support business objectives and market access opportunities.
• Owns the proactive identification, communication, and escalation of regulatory and business risks, ensuring transparency, timely decision-making, and effective mitigation.
• Maintains accurate, complete, and compliant regulatory records and data, ensuring reliable reporting and audit readiness.

Formazione

B.A degree

Descrizione del lavoro

This position is responsible for developing and executing regulatory strategies, preparing regulatory dossiers and overseeing the submissions to facilitate successful product registrations for embecta Singapore, Distributor Markets and Assigned Markets. The manager would act as primary liaison local RA resources such as distributors, independent license holders and RA consultants and when required work with local regulatory authorities. Stakeholder management, project management and registration knowledge is key to this role. They will work closely with internal stakeholders such as Trade compliance, Supply Chain, Quality and as well as external stakeholders such as distributors and Health authorities.

The Manager is to lead and manage regulatory affairs and work with Quality Compliance on vigilance activities for embecta Singapore, Distributor Markets and Assigned Markets. , ensuring compliance with regulatory standards, guidance and legislation to enable and maintain registrations.

Major Accountabilities

• To assess registration requirements and timelines for required markets
• Use, promote and maintain the registration tracker for the countries they are responsible for
• Manage registration activities through local providers. Assist with the preparation of registration dossiers and manage submissions by maintaining close collaboration with distributor regulatory teams and internal regulatory departments.
• Maintain licenses and undertake renewal activity to ensure continuity
• Maintain the embecta eRIM (embecta Regulatory Information System)
• Triage or complete fresh ticket information requests.
• Manage stakeholder expectations including local business managers and to be clear about RA requirements and position
• Provide tender support, RA information to local markets
• Work with the PMS team on Vigilance reporting to competent authorities. Triaging complaints is undertaken by the QA team.
• Provide input to Quality and Supply chain for any Field Actions in accordance with country and global company regulatory requirements.
• To develop and maintain clear and concise project management activities to enable clear understanding of registration activities, actions, progress and timelines
• Provide regulatory input for advertising and promotional material
• Review Regulatory Intelligence material as required and identify any actions we may need to take, for example a change to regulatory registration requirements
• Support regional and international project activities and information requests
• Develops and executes regulatory strategies to support business objectives and market access opportunities.
• Owns the proactive identification, communication, and escalation of regulatory and business risks, ensuring transparency, timely decision-making, and effective mitigation.
• Maintains accurate, complete, and compliant regulatory records and data, ensuring reliable reporting and audit readiness.

POSITION REQUIREMENTS

• B.A degree in Pharmaceutical, Engineering, Chemistry, Life Science or other
• At least 8 years within a regulatory department managing CE technical documents and or ASIA registration activities in a medical device company