Regulatory Affairs Manager II

The Fountain Group; United States; Remote; USD 100,000 - 125,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Manager II to join their team remotely. This role is crucial for ensuring the quality and compliance of ECTD submissions while acting as a liaison between stakeholders and vendors. The ideal candidate will have over five years of experience in Regulatory Operations, a keen eye for detail, and the ability to manage deadlines effectively. If you are passionate about regulatory affairs and want to make a significant impact in the pharmaceutical industry, this opportunity is perfect for you.

Qualifications

• 5+ years in Regulatory Operations with strong attention to detail.
• Knowledge of US regulations regarding ECTD submissions.

Responsibilities

• Liaison between stakeholders and vendors for ECTD submissions.
• Check submissions for bookmarks and regulatory information.

Skills

Regulatory Operations

Quality Control

Attention to Detail

Deadline Management

Job description

The Fountain Group are a national staffing firm and are currently seeking a Regulatory Affairs Manager II for a prominent Pharmaceutical client of ours. This position is Remote (EST Hours). Details for the position are as follows:

Job Description:

1. Pay: 55.00-65.77/hr on W2. No C2C please.
2. 12-month assignment to start with potential for extension or conversion.
3. 100 percent remote. Must work EST hours.
4. 5 plus years in Regulatory Operations.
5. Will work as a liaison between stakeholders and vendors to derive information for the creation and editing of ECTD submissions.
6. Acting as a quality control person on ECTD components, they will check the submission(s) for necessary bookmarks and relevant regulatory information as well as coordinate publishing with the vendor.
7. They will be responsible for finding errors within the documents and follow up on corrections that need to be made prior to submission for publishing.
8. They must know regulations and have insight on what to look for in the ECTD documents.
9. Must be knowledgeable with US region regulations regarding ECTD submission.
10. Must be able to meet deadlines and oversee deliverables on document submissions. Also, have the insight to find errors and follow up on correction of errors within the document.