Regulatory Affairs Specialist
3 days ago
We are seeking a highly skilled Regulatory Affairs Assistant - II to join our team at ATR International. This role is a great opportunity for someone who is passionate about advancing therapeutics against life-threatening diseases, while working with a collaborative team in Regulatory Affairs.
Key Responsibilities:
- Perform data entry using Gilead RIM System to ensure accuracy and completeness of data.
- Collaborate with the team to execute routine data entry tasks, such as inputting submission related dates and regulatory assessment comments.
- Ensure data consistency and correctness, and acquire required system skills and knowledge through training supported by manager and peers.
- Work under the general supervision of more senior Regulatory Affairs CMC professionals.
Requirements:
- Familiarity with data entry into complex information systems.
- Experience with Veeva Vaults, with RIM Vault preferred.
- Strong verbal and written communication skills, and interpersonal skills.
- Excellent organizational skills, with ability to work on multiple concurrent projects with tight timelines.
- Basic understanding of Regulatory Affairs and regulatory requirements in a limited number of areas.
- Scientific background preferred.
- Biologics experience is a plus.
What We Offer:
- A collaborative team environment.
- Opportunities for professional growth and development.
- A competitive salary and benefits package.
How to Apply:
Please submit your resume and cover letter to [insert contact information]. We look forward to hearing from you
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