Regulatory Affairs Manager at Precision Medicine Group (View all jobs) Remote, United States Position Summary: The Regulatory Affairs Manager, Gene Therapy CDx is located in the United States and will be responsible for applying high-level expertise and in-depth knowledge of the regulatory affairs and marketing authorization process. This position will also serve as regulatory liaison/legal manufacturer representative with regulatory agencies and pharma partners for Precision diagnostic products (e.g., companion diagnostics [CDx] and laboratory developed tests [LDT]). Essential functions of the job include but are not limited to:
- Lead the preparation of submissions and other documentation as required for global clearance/approval of Precision's clinical trial assays and IVD-CDx products, including the preparation of regulatory submissions, meeting packages, and negotiations with regulatory officials as required
- Serve as a regulatory lead on Precision CDx program development project teams, contributing toward DHF documentation, project plans and participating in meetings with pharma partners
- Represent Precision in correspondence and meetings with regulatory agencies and Notified Bodies
- Design strategic approaches to regulatory approvals, clearances, and post-market requirements to support co-development programs and reflect optimal business solutions for pharma partners
- Review and direct the development of analytical and clinical protocols, technical reports, and other company documents for use in regulatory submissions and in response to queries from regulatory agencies globally
- Review and edit regulatory communication, submission, timeline, and approval requirement documents for assigned programs and other initiatives
- Stay abreast of latest regulatory developments on a global scale and communicate to the project teams for impact and possible implementation within Precision's CDx programs
- Perform regulatory impact assessment for any changes to clinical trial assays and CDx products for reporting to regulatory agencies
- Support Precision's post-market surveillance program
Qualifications: Minimum Required:
- BS Degree in Sciences, or equivalent in a Scientific, or similar discipline
- Minimum of 5+ years of regulatory experience working in a medical device industry, specifically in-vitro diagnostics, preferably with gene therapy and/or CDx
- Demonstrated knowledge and understanding of global IVD regulations, including but not limited to US, EU, UK, APAC, and MENA regions.
Other Required:
- Strong written and verbal communication skills; highly proficient in spoken and written English is a requirement, proficiency in other languages is a plus
- Ability to prioritize tasks, deadline-oriented, and good organizational skills.
- Ability to think outside of the box and solve difficult problems with effective solutions
- Committed attention to detail
- Strong scientific and analytical skills
- Strong leadership, team building and interpersonal skills
- Direct experience working with small and large companies to design global regulatory and commercialization strategies
- Experience managing staff members and project teams
Preferred:
- Master's degree or Ph.D.
- CDx experience
- Class III IVD and LDT experience
- FDA: PMA, IDE, and Q-Submissions
- EU IVDR experience: Annex XIV, ethics committee submissions, and CE Mark
Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range $95,000 - $133,000 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice . 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 ...@precisionmedicinegrp.com . It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.