RichmondVARecruiter Since 2001
the smart solution for Richmond jobs

Director, Regulatory Affairs

Company: REGENXBIO Inc
Location: Richmond
Posted on: September 13, 2020

Job Description:

We're looking for a candidate to fill this position in an exciting company.

The Director Regulatory Affairs is to be responsible for leading all regulatory activities for a therapeutic area from early development through BLA. You will provide the organization with the leadership and strategy to enable high quality and effective health authority and team communications to effectively drive development process. This person will also manage a regulatory staff for therapeutic areas, will recruit, assign workload, and perform performance appraisals. This person is able and willing to perform all duties or functions of subordinates. The core duties and responsibilities of the Director, Regulatory Affairs are detailed below:

Minimum MS, preferred a PharmD or PhD in biological sciences

5-10 years in Regulatory Affairs experience, including product approval/launch. Expert knowledge of regulatory affairs within one or more therapeutic areas

Previous regulatory experience helping a team prepare for a Major Health Authority interactions (e.g. FDA advisory committee meetings, Oral explanations, Scientific Advice, Pre-NDA/BLA, EOP2 meetings etc.).

RAC certification is a plus.

Highly resourceful team-player, with the ability to also be extremely effective independently

Proactive and creative approaches to problem-solving with strong decision-making capability

Strong written and oral communication skills; comfortable communicating with and building relationships with various stakeholders including external partners and health authorities

Demonstrated performance in resolving global regulatory issues

Experience with preparation of high quality FDA/EMA submission documentation and Health Authority meeting preparations

Keywords: REGENXBIO Inc, Richmond , Director, Regulatory Affairs, Other , Richmond, Virginia

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Submarine Electronics
Description: ABOUT The most secretive of Navy vessels, a submarine requires a select community of specially trained professionals to operate its classified, highly advanced hardware. The Sailors in the Submarine (more...)
Company: Navy
Location: Harrisonburg
Posted on: 09/22/2020

Jr. Systems Engineer - Space Missions
Description: Peraton is seeking a Junior Systems Engineer in Chantilly, VA to support our Intelligence Community customer as part of a highly talented, highly motivated and high-performing team . You will support (more...)
Company: Peraton
Location: Chantilly
Posted on: 09/22/2020

Habitat Logistics: Charlottesville - Delivery Driver
Description: Make 15- 25/Hour delivering food for local restaurants on our app Work when it's convenient
Company: Habitat Logistics
Location: Charlottesville
Posted on: 09/22/2020


MBSE Solution Architect
Description: MBSE Solution ArchitectJob Category:Information TechnologyMinimum Clearance Required to Start:SecretEmployee Type:RegularPercentage of Travel Required:Up to 10 Type of Travel:Continental USJob Description:Are (more...)
Company: CACI, INC.-FEDERAL
Location: Chantilly
Posted on: 09/22/2020

Senior Data Scientist
Description: At CCRi, our clients look to us to solve their hardest problems, and we have a long history of exceeding their expectations. With clients in both the private sector and the US government, we provide a (more...)
Company: CCRI
Location: Charlottesville
Posted on: 09/22/2020

High Demand For Quality Remodelers - Get New Clients In Your Area
Description: Over 25 million homeowners have trusted HomeAdvisor 1800Contractor to help them find quality professionals with the expertise to turn their home improvement
Company: HomeAdvisor
Location: Charlottesville
Posted on: 09/22/2020

Senior Systems Architect
Description: DescriptionJOB DESCRIPTION: SAIC, a leading provider of systems development deployment, targeting intelligence analysis, systems engineering integration, and training capabilities and solutions (more...)
Company: Engility Holdings Inc.
Location: Chantilly
Posted on: 09/22/2020

TransAm Trucking Owner Operator Truck Driver Jobs
Description: New drivers are now eligible for 2,500 in sign-on incentives TransAm Trucking, a leading refrigerated carrier, has owner operator truck driver opportunities available now for CDL-A drivers Apply (more...)
Company: Trans Am
Location: Harrisonburg
Posted on: 09/22/2020

System Integrator
Description: CEdge has an opportunity for aSystem Integrators Mid This role is located inSpringfield/Chantilly VA.If you are ready to work alongside World Renowned Technology experts, and carry the skills below, this (more...)
Company: CEdge Software Consultants
Location: Chantilly
Posted on: 09/22/2020

Service Tech IV
Description: As a Service Tech IV at United Rentals, you'll use your skills to perform maintenance and repairs of complex equipment with limited or no supervision in a highly skilled, safe, and professional manner. (more...)
Company: United Rentals
Location: Charlottesville
Posted on: 09/22/2020

Log In or Create An Account

Get the latest Virginia jobs by following @recnetVA on Twitter!

Richmond RSS job feeds