Regulatory Affairs Lead Jobs

Regulatory Affairs Lead

Global Healthcare Giant

Location – Remote

Salary - $150,000 to $160,000 plus excellent bonus and benefits

For more information, contact Calvin at [email protected]

This Global Healthcare Giant is currently undergoing a period of intense global growth across their entire business. As part of this growth, the business is looking to hire an experienced Regulatory Affairs Leader who will work closely with company leaders to provide regulation strategy and direction for in throughout the developmental stages You will work closely with local regulatory teams in the US while also working within a global team.

As the Regulatory Affairs Lead, you will support the growth and development across the US, as well as work closely with the global leadership team in defining and executing regulatory strategies with the aim of improving efficiency through the developmental stage.

Key targets and responsibilities of the Regulatory Affairs Lead:

• Work closely with the senior leadership team to provide regulatory strategy and direction to the global business for product launch, pre-market submissions/registrations and post market compliance
• Act as a mentor to other colleagues globally
• Work closely with regulatory bodies globally to provide direction across the business relating to regulatory affairs throughout the project life cycle

To be successful as the Regulatory Affairs Lead, you should possess the following experience:

• Experience working within US regulatory affairs within the pharmaceutical or healthcare industry
• Bachelors degree in a scientific discipline or relevant experience (post-graduate degree is preferred but not a requirement)
• Experience of regulatory submissions and approvals, including new BLAs/NDAs
• Experience with licensing including negotiating directly with the FDA

If you are looking for an opportunity with a business that is at the forefront of their industry, then the next step in your career should be here.

To apply, please send a copy of your resume to Calvin at [email protected] or use the apply button on this page.