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Regulatory Specialist or Director of Regulatory Sciences
Keen to become part of a truly global, collaborative team of professionals? Your journey begins here.
Hogan Lovells is an international law firm with an award-winning Life Sciences practice. Our Global Pharmaceutical and Medical Device practices focus on supporting companies through the product life cycle, especially during the premarket and product development stages. Our practice includes attorneys and regulatory specialists with MS and Ph.D./MD advanced degrees (e.g., radiology, biomechanical engineering, biochemistry, genetics, biostatistics) as well as those who previously served as scientific reviewers at the FDA. Many of our attorneys previously served in FDA’s Office of the Chief Counsel and in leadership positions at FDA and in the Department of Health and Human Services.
We assist our clients in developing regulatory strategies, as well as drafting regulatory submissions. Among others, we assist our clients in draft pre submissions; drug and device investigational product applications; meeting requests and briefing packages; orphan drug designation requests; requests for designation under FDA’s expedited programs for serious diseases; and marketing applications. We also represent sponsors during FDA meetings and are integrally involved in responding to FDA requests for additional information. The position offers the opportunity to join a prestigious legal and regulatory group that navigates cutting-edge biopharmaceutical and medical technology through the FDA regulatory landscape.
Alternative work arrangements are available for this position, including a flexible hybrid working arrangement out of any of our U.S. offices, or fully remote.
- Develops, coordinates, and provides biostatistical support for projects related to the development of FDA-regulated medical products, including medical devices, pharmaceuticals, and biotechnology products
- Interacts with product sponsor teams (e.g., Clinical, Regulatory, Statistical Programming, Data Management, and other Research & Development Scientists) in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical medical device, drug, and biologic projects
- Serves as statistical representative for the law firm on the cross-functional teams for the clinical trial planning and execution
- Advises sponsors on appropriate statistical methodology for data analysis; when necessary assists in developing protocols and data analysis plans
- Analyzes data and interprets results from clinical trials to meet objectives of the study protocol
- Prepares written reports to effectively communicate clinical trial design and results to regulatory agencies (e.g., drafting clinical study reports, clinical sections of marketing applications and FDA briefing materials, etc.)
- Provides assistance in drafting and revising medical device premarket submissions, such as Requests for Designation, 513(g)s, Pre-Submission requests, Investigational Device Exemptions (IDEs), 510(k) notices, and/or premarket approval applications (PMAs)
- Provides assistance in drafting and revising submissions for pharmaceutical and biotechnology products, such as Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Biologics License Applications (BLAs)
- Helps prepare responses to queries relating to study design, analysis, and interpretation posed by regulatory agencies
- MS or Ph.D. degree in statistics/biostatistics/epidemiology or MPH with biostatistics focus, with 2+ years relevant experience. Prior work experience at FDA is a plus, but not required.
- Knowledge of statistical analysis methodologies and experimental design
- Working knowledge of statistical and data processing software e.g. SAS and/or R
- Solid working knowledge of Food and Drug Administration regulatory requirements for medical devices, pharmaceuticals, and biotechnology products
- Good oral and written communication skills
- Able to work effectively with personnel with different functional backgrounds and across jurisdictions
- Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.
A resume or CV is a must for our application system. We also encourage you to include a cover letter to tell us why you are interested in this position and a law school (if applicable) and an undergraduate transcript. Please address inquiries for this position to: Kasey Fenn, Regional Associate Recruitment Manger, Western Region.
The annualized salary range for this position is $130,000 to $200,000, depending on the candidate’s overall experience and other job-related factors permitted by law. This position may be eligible for a discretionary or an hours-based bonus. In addition, full-time employees, as well as some part-time employees, will be eligible for the firm’s fringe benefits as they currently exist.
Hogan Lovells is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, age, national origin, disability, sexual orientation, gender identity or expression, marital status, genetic information or protected Veteran status.
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Job posted: 2023-08-30