Regulatory Affairs Manager
1 month ago
**Position: Regulatory Affairs Manager in Bangkok, Thailand | Biopharma MNC**
**Region: Bangkok, Thailand**
**Career Level: Middle**
**Work Experience: 5 - 10 years**
**Employment Type: Permanent, Full-Time**
Are you an experienced and visionary Regulatory Affairs Manager seeking a new opportunity in the biopharmaceutical industry? Or a Senior Regulatory Affairs Executive looking for a place to step-up in your career?
Integrity is currently representing a leading multinational company (MNC) in search of a talented individual to join their Thailand team. As the Regulatory Affairs Manager, you will play a crucial role in overseeing and leading regulatory affairs activities to expedite product approvals and ensure successful market entry in Thailand.
**Main Responsibilities**
- Develop and execute regulatory submission strategies for Thailand, aligned with business objectives.
- Collaborate with cross-functional teams to create regulatory strategies for new product launches and modifications to existing products.
- Prepare and submit product technical documents for registrations, ensuring compliance with international regulatory standards and local authorities.
- Oversee the compilation and submission of responses to regulatory queries during the evaluation process, in collaboration with internal and external stakeholders.
- Ensure product label compliance and coordinate with the supply chain to implement label requirements in commercial shipments.
- Manage the life cycle of the existing product portfolio, ensuring regulatory compliance and license renewals.
- Provide regulatory insights and guidance to the regional regulatory affairs team and internal stakeholders.
- Gather and compile information from the region for the Periodic Safety Update Reports (PSUR).
- Coordinate regulatory operations, collaborating with internal and external stakeholders, including the commercial team and Thailand Health Authorities.
- Lead regulatory affairs activities, such as reports, license transfers, and renewals, to ensure adherence to government regulations and company standards.
**Qualifications**
- Bachelor's degree or PhD in Pharmacy, Pharmaceutical Sciences, or related disciplines.
- Preferred: Registered Pharmacist.
- 5-10 years of experience in Regulatory Affairs, including product registration and life cycle management.
- Extensive understanding of regulatory practices in Thailand.
- Knowledge or experience in medical devices is a plus.
- Knowledge or experience in Quality Management Systems is a plus.
**Essential Qualities**
- Strong problem-solving skills to navigate complex regulatory issues and find innovative solutions.
- Excellent communication skills to collaborate with cross-functional teams and convey regulatory strategies and updates to stakeholders at all levels.
- Flexibility to adapt to changing regulatory environments and requirements.
- The compensation package will be competitive and commensurate with your experience and the value you can bring to the company._
**Job Types**: Full-time, Permanent
**Salary**: ฿500,000.00 - ฿1,000,000.00 per year
Application Deadline: 31/05/2023
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