Director, Regulatory Affairs - IVD & CDx - remote

Location: Washington, District Of Columbia US

Notice

This position is no longer open.

Job Id: 5040

Position Title: Director, Regulatory Consultant

External Description:

Apply your expertise and in-depth knowledge of the regulatory affairs and marketing authorization process for in vitro diagnostics to support life science, small and large pharma companies to develop business solutions for clients and other Precision co-workers.

Why Precision!

We focus on the end from the very beginning, cutting through clutter and helping our clients reach their goal faster. Our collective and collaborative team understands how the pieces fit together, and ensures that findings from each stage inform the rest of the process. The result: We’ve delivered more than 250 market clearances and approvals along with numerous favorable coverage and payment decisions for hundreds of diagnostic products—including groundbreaking, first-to-market innovations. This is where you come in.

A glimpse into the day-to-day:

Consulting Services

Leading preparation of in vitro diagnostic submissions and designing strategic approaches to regulatory approvals, clearances, appeals, and post-market requirements. Handling and reviewing development of analytical and clinical protocols, technical reports and other documents for use in regulatory submissions and in response to queries from regulatory agencies. Collaborating with external thought-leaders and technical specialists to support research and development, regulatory authorization, and marketing.

Business Development

Generating new business through own network. Leading workshops and conference curriculums in the areas of translational and regulatory science for in vitro diagnostics. Considering regulatory strategies that can be used and regulatory approval timelines when evaluating proposals.

Presenting key regulatory considerations of the program to the project team and assisting with presentation material development for bid defense meetings.

Identifying market trends and new ways of thinking by staying abreast of the latest regulatory and scientific developments.

Qualifications:

Minimum Required: Bachelor’s degree in Life Sciences. 5+ years of relevant consulting experience.

Other Required:

  • 7+ years proven experience working in a IVD, pharmaceutical management, clinical trials and/or pharmaceutical services consulting. Direct experience working with small and large companies to craft global regulatory and commercialization strategies.
  • Good written and verbal communication skills. Strong leadership, team building and interpersonal skills. Ability to think outside of the box and solve hard problems with effective solutions.
  • Strong business and financial acumen. Strong scientific and analytical skills. Experience managing staff members and project teams.

Division: Precision For Medicine

Business Unit: Diagnostic Solutions

Office Based: Remote

Employment Type: Exempt

Employment Status: Regular Full-time

Work From Home Available: Yes

City:

Country: United States

State:

Community / Marketing Title: Director, Regulatory Affairs - IVD & CDx - remote

City: Washington

State: District Of Columbia

Country: United States

Company Profile:

Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics, clinical trial delivery, and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.

EEO Employer Verbiage:

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

Location_formattedLocationLong: Washington, District Of Columbia US

Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.

Privacy Policy

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

© 2018-2020 Precision Medicine Group, LLC. All rights reserved