
Regulatory Affairs Specialist
2 days ago
Job Overview
We are seeking a highly skilled Regulatory Associate RA to support our team in ensuring compliance with current regulations and guidelines. The ideal candidate will have excellent research and analytical skills, strong communication and interpersonal abilities, and a keen eye for detail.
Key Responsibilities:
- Assist in the preparation of regulatory submission documents, including INDs, NDAs/MAAs, DMFs, variations, renewals, MATs, and other lifecycle maintenance activities.
- Maintain and update regulatory trackers, submission timelines, and status reports.
- Evaluate and analyze regulatory information to identify precedents and support the preparation of orphan drug designation requests.
- Provide technical assistance to clients, customers, or other stakeholders on general regulatory matters.
- Gather information through files, records, and personal contacts to prepare detailed reports and compose routine correspondence.
Qualification Requirements:
- Bachelor's degree in a relevant field, such as Pharmaceutical Sciences or a related discipline.
- Minimum of 2 years of experience in a regulatory, quality, or document management support role.
- Advanced proficiency in Microsoft Office applications, particularly Excel and Word.
- Excellent time management and project management skills, with the ability to prioritize tasks effectively.
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