Regulatory Affairs & Pharmacovigilance Assistant
This is an agency‑hired role supporting the Animal Health Regulatory Affairs & Pharmacovigilance Countries function for Boehringer Ingelheim Malaysia Singapore Indonesia cluster. The successful candidate will be employed by the agency and assigned to Boehringer Ingelheim Malaysia. This role is not a direct employment with Boehringer Ingelheim.
THE POSITION
We are seeking a Regulatory Affairs & Pharmacovigilance Assistant to support Animal Health product registrations and post-authorization regulatory compliance. In this role, you will help obtain and maintain market authorizations in a timely manner, ensure the local pharmacovigilance system meets country legislation, and support compliance with Boehringer Ingelheim policies and local regulatory authority requirements across the product lifecycle.
This role offers the opportunity to collaborate across functions, contribute to meaningful business initiatives from a regulatory perspective, and make an impact throughout end-to-end product lifecycle management.
TASK AND RESPONSIBILITIES
Regulatory Affairs (RA)
1. Manage product registration activities in line with corporate policies and the strategic direction of Global and ROPU RA, and in accordance with local authority legislation and requirements.
2. Support product lifecycle management activities and assess implications from a RA/PV perspective; work closely with the distributor’s RA team to align RA/PV strategy and priorities for MSI.
3. Coordinate regulatory activities to obtain and maintain licenses and implement changes to product registrations.
4. Maintain regulatory information and dossiers to ensure confidentiality, information protection, and efficient access to regulatory data.
5. Monitor government and industry trends that may impact BI; escalate key issues to the Head of RAPV, MSI and engage with regulatory authorities at country level as needed.
6. Provide regulatory guidance and information to business units and cross-functional stakeholders (e.g., supply chain management).
7. Perform other duties as assigned.
Pharmacovigilance (PV)
1.Report adverse event cases in a timely manner and support adverse event investigations when required.
2.Support local PV training for all Boehringer Ingelheim Animal Health employees in MSI and maintain training documentation.
REQUIREMENTS
- Bachelor’s degree in science, Biotechnology, Pharmacy or a related field
- Minimum 2-3 years of experience in regulatory affairs and/or quality assurance within the pharmaceutical industry
- Strong knowledge of national product registration regulations and procedures. Animal Health background is a plus.
- Proficiency with Microsoft Excel, Word, Outlook, and database applications
- Excellent written and verbal communication skills
- Strong analytical skills with the ability to integrate information and manage documentation
- Ability to work independently and collaboratively as part of a team
- High attention to detail with stronga data accuracy and quality focus
- Strong organizational skills with the ability to manage multiple tasks and deadlines
- Curious, proactive, and willing to learn and take on new challenges
- Able to adapt to changing priorities and tasks in a dynamic environment
About the Assignment Company
Boehringer Ingelheim Malaysia is the host company for this assignment. In this role, you will support Boehringer Ingelheim’s Animal Health Regulatory Affairs and Pharmacovigilance function activities while being employed by the agency.
Why this assignment?
This role offers the opportunity to work closely with Boehringer Ingelheim teams on meaningful operational initiatives in a fast-paced environment. Please note that this is an agency-hired assignment, and all employment terms and conditions will be decided and managed by the agency.
If you would like to be part of this high-performing team, please discuss your interest first with your manager and then submit your application by clicking on APPLY NOW!