Overview
Regulatory Affairs Specialist Jobs in Vietnam at Banner Química, an IMCD company
Title: Regulatory Affairs Specialist
Company: Banner Química, an IMCD company
Location: Vietnam
Responsibilities
We are seeking an experienced HSEQR Specialist to join our team. The successful candidate will be responsible for ensuring compliance with all applicable regulations and standards related to food, pharma, and personal care products, including blending, mixing, and sourcing of ingredients. The role formally reports to the Managing Director of IMCD Malaysia with a dotted reporting line to the Head of HSEQR of the Asia and Pacific region. This is a critical role in our organization, and the successful candidate will have a significant impact on the quality and safety of our products and the satisfaction of our customers. We expect the right candidate to:
- Support the implementation and maintenance of IMCD’s HSEQR Policy and related Quality Management System
- Coordinate implementation of ISO certification, prepare for and schedule internal- and external audits.
- Ensure all SOP’s procedure are in place.
- Ensure local legislation and governance compliance.
- Timely ensuring Corrective actions plan for Customer, external, internal audits
- Support and coordinate Non-Conformance Reports, define and propose corrective and preventive measures.
- Participate and execute HSEQR KPI targets, in consultation with Regional HSEQR and local HSEQR manager.
- Support for Export Compliance process, ongoing monitoring of the daily screening process and act as the go-to person in case of questions or concerns.
- Ensure HS code management, SDS management, supplier evaluation program in place.
- Ensure compliance with local legislation/regulation in respect of HSEQ matters, including ensuring that (i) all food, pharma, and personal care products comply with applicable regulations and standards, including but not limited to FDA, EU, and other global regulatory requirements and (ii) all blending and mixing processes are conducted in compliance with regulations and standards..
- Learn and implement the company's regulatory compliance program, policies, and procedures.
- Monitor regulatory developments and changes that may affect the company's products or operations and advise management accordingly.
- Review and ensure all labelling to ensure compliance with regulations and standards.
- Support and ensure the regulatory aspect of sourcing of ingredients from traders, including ensuring compliance with applicable regulations and maintaining the required documentation.
- Collaborate with cross-functional teams, including ‘production (blending, mixing)’, sales, and marketing, to ensure that all products are in compliance with local, regional, and global regulations and standards.
- Develop and maintain positive relationships with regulatory authorities and industry associations.
- Provide regulatory guidance to internal teams.
Qualification/Education
Master’s degree in chemistry / sciences
Work Experience
- Ideally 6-9 years of work experience in Health, Safety, Environment & Quality roles with increasing responsibility in a reputed Industrial Chemicals business (having experience across Pharma, Food, PC (covering life science) consultancy role either as an expert or as an auditor.
- Solid background and proven record of accomplishment in quality management.
- Understanding of quality systems requirements and regulatory/legal framework and the development of sustainability related systems.
- Analytical and problem-solving skills with a quality mind-set.
- Effective communication and interpersonal skills at all levels.
- Ability to connect and gain commitment from all IMCD stakeholders.
- Dealing with cultural differences (e.g., colleagues, authorities, and customers).
- Experience with global quality procedures and documents.