Senior Regulatory Affairs Executive

4 days ago

Hanoi, Vietnam Takeda Pharmaceutical Full time

**Job Summary**:
**The job requires the person to manage Regulatory Affairs for allocating 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 **strategie**s and product advocacy **strategies**:
***Key & Responsibilities & Accountabilities**:

- Reporting to the Senior RA manager to implement Regulatory Affairs activities
- Implement product registration strategies in line with company goals and registration plan and handle product registrations for assigned products.
- Network with and establish an influential relationship with key regulatory authorities to ensure a smooth and efficient registration and advertising approval process.
- Actively monitor the regulatory environment, including competitor regulatory activities. Develop appropriate response/ action and manage accordingly with internal stakeholders. Work with external consultants to influence for positive changes of the regulatory environment.
- Implement local regulatory SOPs to ensure compliance with local, regional, International and Corporate regulatory SOP’s and other processes in order to maintain good corporate practice and company reputation.
- Be the legally responsible person for Company regulatory licenses e.g. import, selling and product licenses for the assigned products.
- Provide appropriate regulatory and technical expertise to support sales and marketing activities.
- Complete relevant reports within designated timeframes.
- Manage timely submission of PSUR/PBRER to the regulatory authority for the assigned products.
- Convey changes in product license status and pharmacovigilance-related license commitments to the PV department.

**Qualification / Attributes**:

- **University Degree in Pharmacy/ **Medicine.**:

- ** At least 3 - 5 years of experience years in regulatory function in the pharmaceutical **industry**:

- ** Proactive and highly committed to supporting and delivering **results**:

- ** High Sense of Ownership and accountability for **achievement**:

- ** Highly organized and self-**disciplined**:

- ** Good **interpersonal skills
- capable of working and relating with** competent **authorities**:

- ** High level of integrity and good **morals.**:

- ** Innovative and resourceful with** good **analytical and problem-solving **skills**:

- ** Good communication and facilitation **skills**:

- ** A good team player with** good **interpersonal **skills**:

- ** good **written and oral communication skills in **English**:
**Locations**:
Hanoi, Vietnam

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time

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