Head of Regulatory Affairs and Pharmacovigilance, MSI

Boehringer Ingelheim; Kuala Lumpur; On-site; MYR 120,000 - 160,000; Full time

Job summary

A global healthcare company in Animal Health is seeking a Head of Regulatory Affairs and Pharmacovigilance. This role involves managing product registrations, ensuring compliance with regulations, and leading pharmacovigilance efforts. The ideal candidate holds a Bachelor's degree in Veterinary Medicine and has a minimum of 3 years of experience in regulatory affairs. Strong leadership and communication skills are essential for driving innovative solutions in animal health. Join a diverse team committed to improving lives through better health.

Qualifications

• Minimum of 3 years of regulatory affairs or quality assurance experience in the pharmaceutical industry.
• Proven track record in Regulatory Affairs (human or animal).
• Experience working in culturally diverse teams.

Responsibilities

• Manage product registration activities and ensure regulatory compliance.
• Collaborate with distributor RA teams on strategies.
• Monitor and improve pharmacovigilance data reporting systems.

Skills

Leadership and communication skills

Proficiency in Excel, Word, Outlook, and database applications

Strong planning skills and attention to detail

Business acumen

Results orientation

Education

Bachelor’s degree in Veterinary Medicine or relevant major

Job description

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

Our Company

At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family‑owned ever since, Boehringer Ingelheim takes a long‑term perspective. Now, we are powered by 52,000 employees globally who nurture a diverse, collaborative and inclusive culture. We believe that if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve.

Why Boehringer Ingelheim?

With us, you can grow, collaborate, innovate and improve lives.

We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth.

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities.

Want to learn more? visit https://www.boehringer-ingelheim.com