Regulatory Submission Planning and Health Authority Engagement

• Lead crossfunctional planning of regulatory submissions and amendments including ongoing lifecycle management activities (annual reports etc).
• Ensure regulatory alignment across clinical, nonclinical, and CMC components of submissions and ensure alignment between internal teams to support submission timelines.
• Lead strategic planning and preparation for regulatory interactions, develop regulatory questions, meeting objectives, and overall regulatory positioning to guide health authority engagement and inform development decisions.
• Manage submission, agency correspondence, and follow up related to regulatory designations. Document, interpret, and integrate health authority feedback into regulatory and development strategy, and coordinate responses to health authority requests
• Author and lead preparation of regulatory designation applications, such as Orphan Drug, Fast Track, and other applicable expedited programs.

Key Skills and Requirements:

• Bachelor's degree in life sciences or related discipline required; advanced degree preferred.
• Minimum of 10 years of experience in biotechnology or pharmaceutical development, including Regulatory Affairs experience.
• Experience in Radiopharmaceuticals would be beneficial
• Demonstrated experience leading or supporting regulatory strategy, submissions, and health authority interactions for early/late clinical development programs.
• Experience with EMA and CTIS preferred
• Experience with radiopharmaceuticals preferred
• Strong scientific/medical writing skills, with the ability to condense scientific information and data into regulatory narratives.
• Ability to operate effectively and independently in a fast-paced, clinical development environment.

If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com.

Apply Now:

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

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

By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy

Regulatory Submission Planning and Health Authority Engagement

• Lead crossfunctional planning of regulatory submissions and amendments including ongoing lifecycle management activities (annual reports etc).
• Ensure regulatory alignment across clinical, nonclinical, and CMC components of submissions and ensure alignment between internal teams to support submission timelines.
• Lead strategic planning and preparation for regulatory interactions, develop regulatory questions, meeting objectives, and overall regulatory positioning to guide health authority engagement and inform development decisions.
• Manage submission, agency correspondence, and follow up related to regulatory designations. Document, interpret, and integrate health authority feedback into regulatory and development strategy, and coordinate responses to health authority requests
• Author and lead preparation of regulatory designation applications, such as Orphan Drug, Fast Track, and other applicable expedited programs.

Key Skills and Requirements:

• Bachelor's degree in life sciences or related discipline required; advanced degree preferred.
• Minimum of 10 years of experience in biotechnology or pharmaceutical development, including Regulatory Affairs experience.
• Experience in Radiopharmaceuticals would be beneficial
• Demonstrated experience leading or supporting regulatory strategy, submissions, and health authority interactions for early/late clinical development programs.
• Experience with EMA and CTIS preferred
• Experience with radiopharmaceuticals preferred
• Strong scientific/medical writing skills, with the ability to condense scientific information and data into regulatory narratives.
• Ability to operate effectively and independently in a fast-paced, clinical development environment.

If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com.

Apply Now:

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

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

By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy