Overview:
Our client is a leading multinational Fortune 500 company with offices scattered throughout the APAC region. They take on some of the world’s most meaningful challenges, delivering critical insights and innovative solutions to help their customers achieve clean water, safe food, abundant energy, and healthy environments.
If your goals include building a career at a company where pride, passion, and individual initiative really matter - then this is the place for you!
Duties and responsibilities:
We are looking for a highly-competent senior Regulatory Affairs professional to manage RA for all company products to ensure that they are in compliance with statutory and company requirements, and maximize the contribution of RA to the achievement of business objectives by developing the company’s policy positions and product advocacy strategies.
Here are a few bullet points that might make you a fit:
- Support SEA regulatory compliance, reporting, and business partnering activities as indicated by the SEA Manager.
- Check & maintain product compliance documents and ensure continued regulatory compliance of existing products.
- Function as the Vietnamese subject matter expert for product regulations, including developments.
- Support customer compliance inquiries as needed.
- Plan, strategize, and monitor regulatory filings for timely submissions and approvals of new product registrations and variation applications.
- Lifecycle management of existing product portfolio while ensuring smooth supply of products
- Manage new product introduction for general chemicals, biocides, cosmetics and veterinary health products and more
- Provide direction to Marketing, R&D, Supply chain Operations, and Sales to facilitate speed to market and to maintain compliance with applicable regulatory requirements.
- Develop working relationships with local agencies such as the FDA, MOH, MOIT, DOIT, and DAH.
- Work with all appropriate local functions to develop and implement the best regulatory strategies/plans to support commercial goals and product launch excellence.
Qualifications:
- 5-7+ years of experience in regulatory affairs - particularly for the pharmaceutical, chemicals, or water treatment sector
- Knowledge of national (Vietnamese) legislation and regulations related to medicinal products
- Comprehensive understanding of RA and how it impacts other projects & processes
- Good team player, resourceful, high integrity, and excellent English skills
- Bachelor's degree or similar qualifications, preferably with a major in Life Sciences, Pharmacy, Biotechnology, or related fields
Benefits:
- Highly-competitive salary + bonuses
- International medical insurance
- Excellent career development pathway
If you're qualified and interested, please apply immediately! We'll be in touch shortly if there's a mutual fit. However, if this isn't the right role for you - feel free to refer your friends and family, and we'll happily take a look.
Job Type: Full-time
Application Question(s):
- Are you aware that you must have CHEMICALS regulatory affairs experience to be considered for this role? (we are not accepting from other industries)
$ads={1}
$ads={2}