Job Title: Regulatory Affairs Senior Associate
We are seeking a dedicated and detail-oriented individual to join our team as a Remote Regulatory Affairs Senior Associate. This role is an excellent opportunity for an entry-level professional to contribute to a dynamic and innovative organization.
Job Responsibilities:
- The successful candidate will assist the US Regulatory Lead in supporting regional regulatory activities, including IND submissions and agency meetings.
- The candidate will provide and maintain CTA/MA documentation support in collaboration with the Regional Regulatory Lead.
- The candidate will be responsible for creating and maintaining product regulatory history documents and archiving all regulatory documents and agency communications.
- The candidate will review the regional component of the Global Regulatory Plan and provide input to operational deliverables.
- The candidate will collaborate with CRO’s / partners to support site initiation.
- The candidate will coordinate the collection of functional documents in support of regulatory filings.
Skills Required:
- The ideal candidate is an entry-level professional who possesses strong communication skills and the ability to comprehend and articulate scientific information effectively.
- The candidate should hold a bachelor’s degree with a minimum of two years of professional experience or a master’s degree. A background in science or engineering is preferred.
- Proficiency in Office 365 is required, and experience in FDA-regulated or biotech/pharma industries is highly desirable. However, candidates from other regulated sectors with relevant education will also be considered.
- The role is primarily administrative, focusing on the coordination of documentation under managerial oversight.
- The candidate should have strong oral and written communication skills.
- The candidate should have the ability to understand and communicate scientific/clinical information.
- The candidate should have the ability to deal with ambiguity and adapt to changing circumstances.
About SSi People:
With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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