Regulatory Affairs Manager

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

Job summary

An established industry player is seeking a Remote Regulatory Affairs Manager to lead strategic initiatives in regulatory CMC for combination products. This role involves collaborating with cross-functional teams and ensuring compliance with Health Authority requirements. As a temporary position with potential for extension, it offers a unique opportunity to make a significant impact in a dynamic environment. If you have a passion for regulatory affairs and a proven track record in combination products, this role is perfect for you.

Qualifications

• 5+ years of experience in regulatory affairs focusing on combination products.
• Expertise in regulatory CMC submissions is essential.

Responsibilities

• Provide strategic and operational Regulatory CMC expertise.
• Ensure compliance with global regulatory requirements for combination products.

Skills

Regulatory Affairs

Combination Products

Regulatory CMC Submissions

Job description

We are currently seeking a Remote Regulatory Affairs Manager for a prominent client of ours. Details for the position are as follows:

Job Description:

• Shift: 20 hours a week.
• Pay: $100-$121.15/hr depending on experience.
• This is a temporary assignment that is slated for 8 months with the possibility for extension or conversion based on performance and budget.
• The position is responsible for providing strategic and operational Regulatory CMC expertise and support in cross-functional teams, working flexibly within and across regions to provide broad operational support to ensure the delivery of project and business objectives. The position is also responsible for ensuring global regulatory CMC combination product/device strategy for assigned combination products is consistent with the team and business goals and meets Health Authority requirements.

Qualifications:

• 5+ years of experience working within regulatory affairs on combination products.
• Experience within regulatory CMC submissions.