Director, Regulatory Affairs - IVD & CDx - remote
Location: Washington, District Of Columbia US
Job Id: 5040
Position Title: Director, Regulatory Consultant
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.
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:
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.
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.
Minimum Required: Bachelor’s degree in Life Sciences. 5+ years of relevant consulting experience.
- 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
Country: United States
Community / Marketing Title: Director, Regulatory Affairs - IVD & CDx - remote
State: District Of Columbia
Country: United States
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