Job Description

Our client is a leading organization in the pharmaceutical sector, currently seeking a Manager - Scientific & Regulatory Affairs to join their team in Bangkok.

This role offers an excellent opportunity to work in a fast-paced, dynamic environment where you will be instrumental in ensuring compliance with regulatory requirements and advancing the company’s regulatory strategy.

As the Manager - Scientific & Regulatory Affairs, you will play a crucial role in managing all aspects of product registration for a wide range of pharmaceutical products, including OTC, ethical, biological, and other categories. You will collaborate with various internal teams, external stakeholders, and government agencies to ensure smooth and timely regulatory submissions and approvals. Additionally, you’ll be expected to lead and mentor a team, contributing to their professional development while achieving strategic objectives.

Key Responsibilities:

• Leading the product registration process for pharmaceutical products, ensuring timely and compliant submissions for OTC, ethical, biological, and other product categories.
• Reviewing product documentation, coordinating additional documents, clarifications, and samples required for successful product registrations.
• Ensuring all regulatory submissions and approvals adhere to Thai laws, guidelines, and industry regulations.
• Effectively communicating updates and changes to internal stakeholders, ensuring alignment and compliance across the organization.
• Building and maintaining strong relationships with government agencies, actively participating in local regulatory affairs to influence and respond to regulatory developments.
• Identifying and mitigating potential regulatory and quality risks by developing and implementing preventive strategies.
• Staying informed of evolving regulations, industry trends, and the competitive landscape in the regulatory domain.
• Overseeing pharmacovigilance activities for all products, ensuring compliance with Thai FDA regulations.

Qualifications & Experience:

• Bachelor’s or Master’s degree in Pharmacy (or related field).
• At least 5 years of experience in the pharmaceutical industry or regulatory affairs management.
• Experience in managing regulatory affairs for pharmaceutical products.
• Experience in managing 1 or 2 subordinates.
• A valid pharmacist license is required.
• Able to work onsite 100%.
• Proven success in working with the Thai FDA, including experience in key negotiations.

Skills & Knowledge:

• In-depth knowledge of local regulatory requirements and compliance for product registrations.
• Strong leadership, coaching, and team management skills.
• Excellent problem-solving and analytical skills, with the ability to overcome regulatory challenges.
• Ability to stay ahead of regulatory changes and develop proactive strategies.

If you’re ready to take on a leadership role in a thriving pharmaceutical environment and make a meaningful impact, we encourage you to apply. This is a fantastic opportunity to contribute to an industry leader and take your career to the next level. Don’t miss out—apply today!