Head of Regulatory Affairs and Pharmacovigilance, MSI
The Position
As Head of Regulatory Affairs and Pharmacovigilance (Animal Health), you will play a pivotal role in shaping the future of Boehringer Ingelheim’s Animal Health business in Malaysia, Singapore and Indonesia.
This is more than compliance - it’s about leadership, influence, and impact. You will ensure that all regulatory and pharmacovigilance activities for Animal Health products are executed flawlessly, in line with Boehringer Ingelheim’s global standards and local regulations.
Your expertise will guarantee timely product registrations and renewals, enabling us to deliver innovative solutions that improve animal health and well-being.
Duties and Responsibilities
As Head of Regulatory Affairs, you will:
- Manage product registration activities in line with corporate policies, global/ROPU RA strategies, and local legislation; develop action plans and monitor implementation
- Collaborate closely with distributor RA teams on RA/PV strategies and priorities
- Maintain and update global RA databases (e.g., WWPPS, CPD3, BIRDS) and ensure confidentiality and agility in handling regulatory dossiers and information
- Organize and track registration processes; identify synergies and initiate communication with local authorities
- Monitor regulatory trends and anticipate changes (Regulatory Intelligence); proactively identify government and industry issues impacting BI and build strong relationships with authorities through regular visits and negotiations
- Drive best practices and manage training for RA colleagues to ensure high-quality output
- Maintain detailed knowledge of local registration requirements and competitor approaches; anticipate new regulatory developments
- Represent BI in training programs, symposiums, and industry meetings; foster positive relationships with authorities and trade associations
- Support business units and colleagues (e.g., supply chain) by hosting regular RA meetings to communicate regulatory updates
For Pharmacovigilance activities, you will:
- Monitor and improve PV data collection and reporting systems; ensure accuracy and completeness of PV information; enter Adverse Event Reports (AERs) into PV Express II
- Notify Global PV of local PV signals or authority concerns; inform ROPU and Global PV of safety actions; exchange PV information per agreements
- Prepare and update local PV SOPs; ensure PV training for all OPU personnel and document compliance
- Maintain PV systems and training for third parties; report AERs in humans and drug exposure during pregnancy for shared active ingredient products immediately to L-PV HP
About Our Future Employee
- Bachelor’s degree in Veterinary Medicine or relevant major
- Minimum of 3 years of regulatory affairs and/or quality assurance experience in the pharmaceutical industry
- Proficiency in Excel, Word, Outlook, and database applications
- Fluency in written and spoken English
- Leadership and communication skills
- Proven track record in Regulatory Affairs in the pharmaceutical industry (human or animal)
- Experience working in culturally diverse teams
- Strong planning skills and attention to detail
- Business acumen and project management skills
- Strong accountability and results orientation