Regulatory Affairs Manager

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Regulatory Affairs Manager – Pharmaceuticals

We are seeking an experienced Regulatory Affairs Manager to drive regulatory strategy, launch readiness, compliance, and operational excellence across the Philippines while coordinating regulatory operations and selected cross-country initiatives across the ASEAN Cluster. This role is critical in safeguarding Bayer’s license to operate, enabling successful product launches, and ensuring ongoing compliance across the product lifecycle.

Do something that moves you:

• Lead regulatory strategy and execution for pipeline and marketed pharmaceutical products.
• Oversee submissions, registrations, renewals, variations, and lifecycle management activities.
• Build and maintain strong relationships with the Philippine FDA, health authorities, and key external stakeholders.
• Ensure compliance with regulatory requirements, audits, inspections, and internal quality systems.
• Monitor and assess regulatory changes, providing proactive guidance on business impact and risk mitigation.
• Provide regulatory support for business development, licensing, and due diligence activities.
• Engage with health authorities, industry associations, and external stakeholders to support regulatory policy development and sustainable business growth.
• Serve as a key coordinator for ASEAN regulatory operations, leading governance forums, cross-country execution, decision-making processes, and ASEAN project delivery.
• Partner with global, regional, and local stakeholders to support business objectives, market access, and launch readiness.
• Lead regulatory activities across the Philippines and coordinate ASEAN regulatory operations and cross-country initiatives within a matrix organization.

Does this sound like you?

• Master’s degree in Life Sciences, Pharmacy or a related discipline (registered pharmacist preferred).
• 7–10+ years’ Regulatory Affairs experience within the pharmaceutical industry, including people leadership experience.
• Strong knowledge of the Philippine regulatory environment and Health Authority engagement.
• Demonstrated success managing major regulatory submissions, approvals, and product lifecycle activities.
• Successful engagement with Philippine FDA and other ASEAN Authorities highly desired; exposure to FDA/EMA regulations is advantageous.
• Proven ability to influence stakeholders across complex matrix organisations and drive business-focused outcomes while maintaining compliance.
• Excellent communication skills with the ability to translate complex regulatory requirements into practical business recommendations.

What You Bring

• Strategic thinking and strong business acumen.
• Experience working across diverse cultures and regional teams.
• Ability to manage complexity, ambiguity, and competing priorities.
• A collaborative leadership style aligned with Bayer’s VACC values and commitment to inclusion, innovation, and customer focus.

Join Bayer and help shape the future of healthcare by enabling access to innovative medicines across the Philippines and ASEAN.

Local regulations and legal requirements vary per country of hire and will be discussed with considered candidates individually based on their potential of hire.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.          

If you meet the requirements of this unique opportunity and want to impact our mission Science for a better life, we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice.    

IMPORTANT NOTE for POTENTIAL CANADIAN CANDIDATES: This position requires full vaccination against COVID-19.       

IMPORTANT NOTE for POTENTIAL GERMAN CANDIDATES: Applications from employees in Germany who may be affected by personnel reduction will be treated favourably from other candidates in Germany.       

IMPORTANT NOTE for POTENTIAL US CANDIDATES: Bayer expects its employees to be fully vaccinated against COVID-19. Bayer active employees are also expected to disclose their vaccination status and if fully vaccinated, provide proof of vaccination status to Occupational Medicine. Bayer defines fully vaccinated in alignment with CDC which is two weeks after completing the two-dose vaccine regimen or two weeks after completing the one-dose regimen. Additionally, Bayer employees are also required to comply with state, local and customer requirements.