Assistant Manager, Regulatory Affairs

The Regulatory Affairs Assistant Manager works within the Regulatory Team to develop regulatory strategies and implementation plans for the preparation and submission of new products and its life cycle. Provide responses to regulatory agencies regarding product information or issues. The guidance from the Head of Regulatory, the incumbent shall advise and guides clients to prepare and ensure all matters on regulatory agency applications, governance, reports, or correspondence are maintained, and service levels are met.

KEY RESPONSIBILITIES

• Develop and review all regulatory strategies, product submission materials, implementation plans to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
• Prepare and submit regulatory documents, including product registration, notifications, and submission to regulatory authorities.
• Maintain accurate and up-to date regulatory documentation and records.
• Work closely with cross-functional and internal team to establish and maintain robust regulatory governance processes and ensure adherence to quality and compliance standards.
• Manage activities such as audits, regulatory agency inspections, or product recalls as necessary.
• Provide responses to regulatory agencies regarding product information or issues.
• Stay abreast of regulatory requirements and changes affecting industry and products including interpret, coordinate, and communicate impact assessment on regulatory requirements to internal and external stakeholders.
• Assist to Head of Regulatory to review promotional materials to ensure that regulatory agency requirements are met.
• Participate in the development, training, or implementation of standard operating procedures for internal and external stakeholders.
• Work closely with internal and external stakeholders (i.e. Pharmacovigilance, Marketing, Finance, Regulatory Authorities) to ensure all the responsibilities and agreed services for the clients are met.
• Support the Regulatory Affairs team for any regulatory affairs adhoc requests, not limiting to Product Review, Regulations, Guidelines.
• The incumbent will undertake assigned follow-up actions or new regulatory related projects as required by Head of Regulatory Affairs (if applicable).

TECHNICAL COMPETENCIES / QUALIFICATIONS

• Minimum 3 years of working experience with bachelor's degree in pharmacy, science or related field.
• Knowledge of Regulatory Submission for Pharmaceuticals And Medical Devices
• Understanding Regulations, Acts and Guidelines for Registration, GMP, GDP, Pharmacovigilance
• Understanding Licensing and Certification requirements for Company, Wholesale, Distribution and maintaining these licenses and certificates
• Understanding advertising guidelines and requirements