Director, Regulatory Strategy & Submissions

IQVIA; Washington (District of Columbia); On-site; USD 135,000 - 377,000; Full time

Job summary

IQVIA is seeking a Director of Regulatory Affairs to lead regulatory strategy and submissions for client projects within the MedTech sector. You will manage regulatory filings (IND, BLA, 510(k), IDE, PMA) and interact with regulators and clients, while mentoring junior staff and guiding project timelines.

The role requires at least five years in Regulatory Affairs, strong knowledge of FDA/ICh/ISO guidelines, and proven leadership in a multidisciplinary environment.

Qualifications

• Bachelor’s degree in a scientific, engineering, or regulatory discipline (e.g., CMC); MS or PhD preferred.
• Minimum five years of Regulatory Affairs experience with FDA oversight of various human medical products (HCT/Ps, drugs and/or biologics, medical devices, and combination products).
• Experience in regulatory deliverables and submissions and project/people management.
• Strong written and verbal communication, leadership, and mentoring abilities.
• Knowledge of FDA, ICH, ISO regulations and cross-functional collaboration with engineering and clinical teams.

Responsibilities

• Develop and manage regulatory submissions (IND, BLA, 510(k), IDE, PMA).
• Lead regulatory strategy, classification, and jurisdiction activities.
• Interact with regulatory agencies; manage client communications and expectations.
• Oversee regulatory staff, mentoring junior team members and ensuring timely deliverables.
• Collaborate with clinical, reimbursement, and quality assurance teams on regulatory plans.
• Guide multiple projects with competing deadlines and deliverables.

Skills

Regulatory strategy

Regulatory submissions

Project management

Team leadership

Mentoring

Education

Bachelor’s degree in science/engineering/regulatory (e.g., CMC)

MS or PhD preferred

Tools

MS Office

Excel

Word

PowerPoint

Job description

IQVIA is seeking a Director of Regulatory Affairs to lead regulatory strategy and submissions for client projects within the MedTech sector. You will manage regulatory filings (IND, BLA, 510(k), IDE, PMA) and interact with regulators and clients, while mentoring junior staff and guiding project timelines.

The role requires at least five years in Regulatory Affairs, strong knowledge of FDA/ICh/ISO guidelines, and proven leadership in a multidisciplinary environment.