Job Title: Regulatory Affairs Manager II
Location: 100% Remote (EST time zone)
Job Responsibilities:
- Manage eCTD submissions across our client’s product portfolio to Health Authorities for global development and lifecycle management submissions.
- Coordinate all publishing deliverables, ensuring alignment with the strategic direction of assigned programs/products.
- Oversee outsourced publishing deliverables on a daily basis to ensure the successful execution of operational activities for assigned products.
- Act as the primary point of contact for regulatory functions as appropriate in the product’s lifecycle.
- Ensure submission deliverables are incorporated and visible to all stakeholders, and that handoffs and deliverables from the authoring community are on time and meet submission standards and quality expectations.
- Responsible for ensuring electronic submissions and documents meet regulatory agency and our client’s submission standards and technical requirements.
Skills Required:
- 3-5 years of experience in regulatory operations providing submission delivery support for the US and Europe.
- Experience overseeing publishing vendors preferred.
- Proficient in the use of electronic document management and submission publishing tools.
- Expert knowledge of submission or technology-related Health authority guidelines/regulations.
- Strong quality control skills, with experience checking on electronic common technical (eCTD) components, final submissions, hyperlinks, and bookmarks.
- Familiarity with local health authority guidelines and ensuring submissions adhere to these guidelines.
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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