Responsible for implementing regulatory strategy and managing operational activities for assigned regions.
Provides input into global regulatory strategy, including identification of gaps or risks in global strategic plan for assigned regions.
Partners with regions to align on regulatory strategy in order to fulfill business objectives
Represents DRA on or leads sub-teams as required.
Determines requirements and sets objectives for Health Authority (HA) interactions with regulatory lead
Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents.
Develops and implements plans for timely response to HA requests and coordinates responses.
Drives coordination, planning, and submission of dossiers in assigned regions worldwide.
Review of global dossier summary documents.
Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).
Responsible for finalization and on time submission of annual reports and renewals across assigned regions.
Responsible for appropriate entering and quality of product specific attributes in compliance database.
Ensures regulatory compliance for project and keeps records of all major HA interactions in the validated document management system.
Ensures quality and compliance with global regulatory requirements (regions responsible) and adherence to regulatory internal policies and processes.
Skills:
Prior 2-4 years of regulatory experience required, ideally in US or EU
Strong knowledge of regulatory submission and approval processes, ideally in US or EU
Strong interpersonal, communication, negotiation and problem solving skills.
Prior history with post-marketing/brand optimization strategies and commercial awareness preferred.
Proven ability to analyze and interpret efficacy and safety data.
Regulatory operational expertise
Science based BS or MS with requisite experience and demonstrated capability.
Richha Saini
Senior Clinical/Scientific Recruiter
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.967.3439 | Fax: 973.998.2599
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Job details are sourced from the employer's original posting.
Open job postingAbout the company
Artech is an employer-of-choice for the last 25 years to over 7,500 consultants across the globe. We recruit top-notch talent for over 70 Fortune and Government clients coast-to-coast across the U.S., India, and China. We are #1 Largest Women-Owned IT Staffing Firm in the US and this may be your opportunity to join us! For more check: www.artechinfo.com