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Regulatory Affairs Manager

1 month ago

กรงเทพมหานคร, Thailand PRTR Full time

Our client is one of the world's leading Premium Generic Pharmaceutical Companies.

**Key Responsibilities**:

- Developing and maintaining regulatory strategies for product development and post-approval activities.
- Collaborating with cross-functional teams, such as R&D, quality, and manufacturing, to ensure compliance with regulatory requirements.
- Representing the company in interactions with regulatory agencies, such as the FDA.
- Preparing and submitting regulatory filings to the relevant regulatory authorities.
- Leading interactions with regulatory authorities during the review and approval process.
- Monitoring and staying current with regulatory developments, guidelines, and changes in laws.
- Ensuring that the company's products and promotional materials comply with regulations.
- Providing regulatory guidance to other departments within the company.
- Participating in the preparation of responses to regulatory agency inquiries.
- Keeping informed of international regulatory requirements, as well as those of individual countries.
- Providing regulatory input to project teams, including risk assessment and identification of regulatory pathways

**Qualifications**:

- Bachelor's degree in a scientific field, such as pharmacology, pharmacy, or biology
- Minimum of 3 years of experience in regulatory affairs in the pharmaceutical industry.
- Knowledge of global pharmaceutical regulations and guidelines, including FDA, and GMP regulations.
- Strong organizational, project management, and leadership skills.
- Strong written and verbal communication skills.
- Strong attention to detail and ability to work in a fast-paced, deadline-driven environment.