# Director, Regulatory Affairs

**Company**: IQVIA MedTech
**Location**: Washington, DC, DC
**Experience**: senior
**Job type**: full-time
**Salary**: $128,800.00 - $358,800.00
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Washington-DC-United-States-of-America/Director--Regulatory-Affairs---Regenerative-Medicine---Biologics-Quality_R1578608?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_1362c849-613

## Description

IQVIA MedTech is seeking a Director, Regulatory Affairs to support regulatory strategy and submissions for its clientele. The successful candidate will manage the development of regulatory submissions, develop overall regulatory strategy, communicate with regulatory bodies and clients, and lead or expand new therapy ideas.

**Responsibilities and Duties**

- Develop and execute regulatory services for client companies, including regulatory submissions, regulatory agency interactions, regulatory strategy, analysis and development, and product classification and jurisdiction.

- Manage Regulatory Affairs staff, facilitate professional development, and ensure regulatory projects are completed accurately and on time.

- Lead/manage business development functions to secure new clients and projects.

- Develop project and departmental budgets and timelines.

- Work directly with client companies and/or regulatory bodies without oversight.

- Provide project leadership while maintaining sole relationship with client companies.

- Lead people development projects, working alongside team managers.

- Work collaboratively with other MCRA departments, including clinical, reimbursement, and quality assurance.

**Required Knowledge, Skills, and Experience**

- Bachelor's degree in a scientific, engineering, or regulatory discipline; MS or PhD preferred.

- Minimum five years of experience in Regulatory Affairs related to FDA oversight of various human medical products.

- Understanding of FDA regulations, clinical development, and data analysis.

- Possesses US and/or International regulatory experience/fluency with regulations, standards, and guidance documents.

- Domain-specific regulatory expertise in regenerative medicine or other MCRA areas of regulatory and scientific expertise.

- Strong attention to detail, ability to work individually and within a multi-disciplinary team, and strong written and verbal communication skills.

- PC/Technical skills: MS Office, Excel, Word, PowerPoint.

**Benefits**

- The potential base pay range for this role, when annualized, is $128,800.00 - $358,800.00.

## Skills

### Required
- FDA regulations
- regulatory affairs
- clinical development
- data analysis
- MS Office
- Excel
- Word
- PowerPoint

### Nice to have
- domain-specific regulatory expertise in regenerative medicine
- statistical analysis

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Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Washington-DC-United-States-of-America/Director--Regulatory-Affairs---Regenerative-Medicine---Biologics-Quality_R1578608?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)