Atlantic Management Resources has partnered with an emerging specialty pharmaceutical company looking for a Pharmaceutical Regulatory Associate . This is an excellent opportunity for an experienced Regulatory Specialist with a pharmaceutical background providing regulatory and operational support to the Regulatory Affairs Department.
Responsibilities:
- Supporting the respective US CMC Team in the preparation for ANDA/NDA applications ensuring the timely submission readiness of documents to regulatory authorities.
- CMC regulatory subject matter expert for the assigned tasks and activities towards internal and external stakeholders
- Interfacing with the relevant technical expert departments as Global Regulatory Affairs contact point for project planning purposes, compilation, and updates of technical documentation, and for addressing CMC regulatory questions.
- Contributes to the development of USFDA and global regulatory processes.
Qualifications:
- Bachelor’s degree or higher in science, (e.g. pharmacy, chemistry, biotechnology, microbiology, biomedical sciences etc.)
- Three to five years’ experience in ANDA/NDA CMC regulatory affairs.
- Experience working in a rapidly growing company while quality and compliance systems are maturing (preferred)
- High level of proficiency in relevant software (i.e., MS Word, Excel, Power Point, MS Teams, MS Office, Adobe, Document Management Systems, Familiarity with eCTD requirements and Publishing and regulatory software systems.
Salary & Bonus:
- Base Salary – $65K – $75K
- Bonus – 10% – 15% Annual
- Benefits – comprehensive health plan, 401K with company match