Regulatory Affairs Lead

Looking to escape your long commute to work? Unlock your new remote working position with this exciting role in Regulatory Affairs!

R&D Partners is seeking a Regulatory Affairs Strategist to support regulatory strategies and ensure compliance with U.S. health authority requirements. You will play a key role in guiding product development, preparing for FDA meetings, and managing communications with regulatory agencies. This position requires strong leadership, communication skills, and the ability to navigate complex regulatory processes. This is a fully remote working position.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Provide guidance on regulatory pathways to speed up product development, such as accelerated approvals or priority reviews.
• Prepare cross-functional teams for major FDA meetings and lead these discussions.
• Manage and respond to FDA information requests and other health authority communications.

Key Skills and Requirements:

• A degree in a scientific field.
• Proven working history in regulatory affairs, including leading FDA meetings and submitting major applications.
• Strong leadership and teamwork abilities, with excellent verbal and written communication skills.
• Knowledge of regulatory standards, including GMPs, GLPs, and GCPs, and the ability to interpret regulatory guidelines.
• Commitment to ethical practices and sound decision-making in risk assessment.

Compensation:

• $180,000 to $200,000 per annum.

For more information, please contact Syem Mannan.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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