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Job type: Contract

Discipline: Operations

Location: United States

Sr Manager Global Regulatory Strategy - Contract - Remote

Work from anywhere and shape powerful strategies that drive results! Enjoy the freedom of remote work while making a global impact within Global Regulatory.

Proclinical is seeking a Sr Manager Global Regulatory Strategy to oversee clinical trial activities across multiple programs.

Primary Responsibilities:

This role focuses on regulatory submissions, agency interactions, and ensuring compliance with global standards. You will play a key part in developing regulatory strategies that align with corporate goals and support the successful progression of development projects.

Skills & Requirements:

Proven experience working within Global Regulatory Teams (GRTs) and cross-functional teams.
Strong knowledge of drug development processes, ICH guidelines, and regulatory frameworks.
Hands-on experience with INDs, CTAs, IMPDs, Orphan Drug Designations, and agency advice.
Clear understanding of submission content and format requirements.

The Sr Manager, Global Regulatory Strategy's responsibilities will be:

Serve as the regulatory affairs lead for clinical trial activities, including CTA submissions, responding to agency queries, IP release, and label reviews.
Develop tailored regulatory strategies for assigned projects, incorporating clinical, nonclinical, and CMC considerations while adhering to corporate and regulatory guidelines.
Coordinate the preparation and submission of regulatory documents to relevant agencies, ensuring alignment with corporate objectives.

Compensation:

$80 to $100 per hour

If you are having difficulty in applying or if you have any questions, please contact Janelle Jones at j.jones@proclinical.com

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.

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