Regulatory Affairs Manager

2 weeks ago

Bangkok, Bangkok, Thailand Winlife Pharma Co., Ltd. Full time ฿1,200,000 - ฿2,400,000 per year

Winlife Pharma is a prominent pharmaceutical player and leading distributor in Thailand, renowned for its commitment to providing high-quality medicines and healthcare products. With a robust presence in multiple countries, Winlife Pharma operates offices across various regions, facilitating seamless distribution and supply chain management. The company boasts a strong import network, sourcing medicines from reputable markets including Canada, Malaysia, and India. This strategic approach ensures access to a diverse range of pharmaceutical products, Nutraceuticals and Food supplements enabling Winlife Pharma to meet the evolving needs of healthcare providers and patients across the region. We are located at Bangkok. We are currently requiring the qualified person to join with our company. If you are interested to join our growing rapidly team.

Job Description:

  • Prepare registration dossier according to FDA requirement and prepare the documents for post approval changes liaising with FDA requirements.
  • Timely communicate internal teams about updates from Thai FDA on registration status and regulatory relevant activities.
  • All required elements for product registration are scheduled correctly and in place to meet the target filing and registration dates.
  • Submission of Pharmaceutical products/Food Supplement for registration and follow up with FDA to obtain timely or earliest approvals.
  • Able to manage in technical skills including regulatory and product quality perspectives.
  • Coordinate with internal and global regulatory team to ensure that the registration dossier, packaging artworks meet the requirements of Thai FDA and properly manage and resolve the issues.
  • Support and work closely with cross functional teams such as sales & marketing and quality team of relevant issues.
  • Responsible for all activities of RA and relevant related RA activities.

Qualifications:

  • Bachelor's degree in Pharmaceutical Science
  • Minimum 2-5 years working experience in regulatory affairs area (experience in pharmaceutical/biological product in an advantage)
  • Have good experience in working with FDA in preparation of documents for the product registration until product marketing approval.
  • Understanding of the rules and regulations for Pharmaceutical/Biological products.
  • Good command in English (speaking, reading and writing)
  • Good at computer skills (MS Office, MS Excel, Adobe etc.)

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