Senior Regulatory Affairs Manager

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Job Description

Job Title:Senior Regulatory Affairs Manager

Location:Vietnam

About the role:

The job requires the person to manage Regulatory Affairs for assigned products to ensure they are in compliance with statutory and company requirements and maximize the contribution of Regulatory Affairs to the achievement of Business Vietnam objectives through active assistance in the development and implementation of the company’s policy positions and product advocacy strategies.

How you will contribute:

Regulatory Strategy and Market Intelligence

• Develop and execute regulatory strategies for assigned products aligned with corporate objectives and evolving market dynamics.
• Stay updated with global and local regulatory changes, healthcare policies, and competitor activities to ensure compliance and competitive advantage.
• Collaborate with senior leadership on product portfolio planning and market access strategies.
• Incorporate regulatory intelligence to expedite market entry and maintain a competitive edge.
• Actively engage in pharma groups to foster collaboration and share expertise for accelerating product registration processes.
• Drive innovative solutions and initiatives to streamline regulatory processes with PG RA team.

Product Registration

• Manage the end-to-end registration process for assigned products, ensuring full compliance with regulatory standards.
• Create and maintain detailed registration plans while building effective relationships with regulatory authorities for efficient approvals.
• Oversee and approve packaging, product information, advertising, and promotional materials for compliance.
• Implement and follow global, regional, and local regulatory SOPs, ensuring alignment with corporate standards and safeguarding reputation.
• Monitor trends and competitor activities in the regulatory environment, devising proactive action plans to address any changes.
• Supports the development and implementation of the established external regulatory influence strategy.
• Establish relationship with key regulatory officials (throughout direct interactions, industry associations, etc.) to influence regulators to foster positive regulatory environment for business and research.

Cross-Functional Strategic Alignment

• Work closely with BUH, Medical, Quality, and Legal and supply Chain teams to ensure regulatory strategies align with broader organizational goals.
• Provide regulatory guidance and technical expertise to support Commercial, marketing, and strategic decision-making.
• Proactively advocate for regulatory changes that contribute to innovation and support sustainable business growth.

What you bring to Takeda:

• University Degree on Pharmacy/ Medicine.
• At least 3 – 5 years of Regulatory Affairs Manager experience
• Proactive and highly committed to support and deliver results
• High Sense of Ownership and accountability for achievement
• Highly organized and self-disciplined
• Excellent interpersonal skills- capable of working and relating with senior authorities
• Innovative and resourceful with excellent analytical and problem-solving skills
• Excellent communication and facilitation skills
• A good team player with excellent interpersonal skills
• Excellent written and oral communication skills in English

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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