Our client is seeking a Regulatory Affairs Manager to join their team. You will be working closely with the Director of Scientific & Regulatory Affairs, managing all activities related to product registration for various categories including Pharmaceutical products, OTC, Ethical, Biological products and more. Your excellent interpersonal skills will be crucial in cultivating relationships with government agencies and ensuring compliance with local laws and regulations.
- Opportunity to work in a fast-paced environment
- Manage product registration for diverse categories
- Cultivate relationships with government agencies
What you'll do:
As a Regulatory Affairs Manager, you will play a pivotal role in managing all aspects of product registration across diverse categories. You will review and evaluate product documentation, ensuring that all submissions are compliant with local laws and regulations. Your strong communication skills will enable you to effectively relay approved information or changes to relevant departments within the company. You will also take the lead in local government affairs activities, fostering close relationships with government agencies. Your proactive approach will be key in identifying potential regulatory & quality risks and developing preventive strategies. Additionally, you will manage all Pharmacovigilance activities according to Thai FDA regulations and ensure proper documentation of registered products. A significant part of your role will involve coaching and developing team members to meet set goals and objectives.
- Manage all activities related to product registration for various categories.
- Review and evaluate product documentation and coordinate for any additional requirements.
- Ensure all submissions/approvals comply with local laws, guidelines, regulations and practices.
- Communicate approved information or changes to relevant departments.
- Take initiative in local government affairs activities.
- Provide input on potential regulatory & quality risks and develop preventive strategies.
- Maintain high level of regulatory intelligence.
- Manage and coordinate all Pharmacovigilance activities according to Thai FDA regulations.
- Ensure documentation of registered products.
- Develop and coach team members to meet set goals and objectives.
What you bring:
The ideal candidate for this Regulatory Affairs Manager position brings a wealth of experience from the pharmaceutical industry or Drug Regulatory affairs. With at least 5 years of management experience under your belt, you possess a deep understanding of Pharmaceutical products, OTC, Ethical, Biological products and other categories. Your pharmacist license attests to your expertise in the field. You are proficient in using MS Office and have excellent English language skills. Your ability to multitask and deliver on multiple projects demonstrates your strong organisational skills. Furthermore, your excellent working relationship with Thai FDA will be instrumental in this role.
- Bachelor’s Degree or Master’s Degree in Pharmacy
- At least 5 years management experience in pharmaceutical industry or Drug Regulatory affairs
- Experience in Pharmaceutical products, OTC, Ethical, Biological products is an advantage
- A pharmacist license is necessary
- Professional use of MS Office
- Fluency in English language – speak, read, write
- Ability to multitask and deliver on multiple projects
- Excellent working relationship with Thai FDA
What sets this company apart:
Our client is a leading player in the Pharmaceutical Healthcare industry. They offer a fast-paced and dynamic work environment where you can learn and grow. They value their employees and provide ample opportunities for professional development. Their commitment to maintaining high standards of regulatory compliance makes them a trusted name in the industry.
What's next:
If you're ready to take your career to the next level, don't hesitate!
Keywords: Regulatory Affairs, Pharmaceutical Healthcare, Product Registration, Pharmacovigilance, Government Affairs
Due to the high volume of applications, our team will only be in touch if your application is shortlisted.
Robert Walters Recruitment (Thailand) Limited
Recruitment License No.: น. 1188 / 2551
