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Regulatory Affairs Associate Director

4 weeks ago

New York, New York, United States KMR Search Group Full time

Regulatory Affairs Job Description

**Overview**

KMR Search Group is seeking an experienced Regulatory Affairs Associate Director to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with global regulations and guidelines governing pharmaceutical drug development.

**Responsibilities**

* Serve as a liaison between our company and regulatory authorities, including the FDA and other health authorities
* Develop and implement regulatory strategies to support our development and marketing objectives
* Manage regulatory activities associated with our development programs
* Provide regulatory guidance and communicate regulatory goals to multidisciplinary project teams
* Edit and manage the editing of scientific sections of regulatory documentation
* Assist with the writing, review, and preparation of regulatory submissions
* Perform critical analyses of data and develop interpretations and conclusions
* Review clinical protocols and study reports to ensure compliance with regulatory requirements

**Requirements**

* Advanced technical degree in life sciences
* Expert knowledge of regional health authority regulations and global regulations
* Demonstrated interactions with local health authorities
* Excellent communication and analytical skills
* Leadership and project management skills

**Benefits**

* Medical, dental, and vision insurance
* 401k plan with company match
* Stock options and restricted shares of stock
* Outstanding relocation package
* Cost of living adjustments

**About KMR Search Group**

KMR Search Group is a leading provider of recruitment services for the life sciences industry. We are committed to helping our clients find the best talent to drive their business forward.