WHO WE ARE:
Theradaptive is revolutionizing the field of therapeutic delivery with a pipeline of best-in-class products that address multiple global markets. Theradaptive is performing cutting edge science in the area of regenerative medicine, working at the interface of Biology and Orthopedic tissue repair.
Our lead therapeutics are in the following indications:
- Spinal Fusion
- Long Bone Repair
- Osteochondral Repair
- Dental and Facial Bone Repair
We are an innovative, fast-paced team that is advancing a diverse array of cutting edge translational research projects. With Theradaptive, you will experience the challenge and satisfaction of the therapeutic product development process first hand. Transform your career and join the Theradaptive team today!
Theradaptive is honored to be recognized as one of Maryland’s Future 20 Start-up Companies, an elite group of innovative start-ups with the “potential to be the state’s next major business success story".
We are seeking a proactive, enthusiastic, and independent Manager, Clinical and Regulatory Affairs with expertise in regulatory filings and management of clinical trials. The Manager, Clinical and Regulatory Affairs’ primary responsibility will be the preparation of US FDA pre-submissions and submissions, IRB/Ethics filings and trial management. The individual may be based in the Maryland/DC Beltway area but we will consider remote work. This position will interact with all parts of the organization including Research and Development, Analytical Development, Regulatory and Quality. Knowledge of combination devices is a plus.
Our ideal candidate will possess a breadth of knowledge and creativity and will be highly motivated. The candidate will be detail-oriented and have a proven ability to multi-task and pivot quickly based on project priorities. Excellent interpersonal skills and the ability to work well with internal and external staff at all levels is an important skill set needed to succeed in this role.
If you are driven to contribute in a highly dynamic environment, we encourage you to apply now!
- Preparation of IDEs/CTAs to support Phase 1-3 clinical trials. This may include writing and compiling preclinical, clinical, and administrative sections of FDA filings for Combination Products.
- Experience in CTD format is a plus.
- Manages IDE lifecycle and maintenance activities (e.g., protocol amendments, clinical/preclinical information amendments, annual reports, DSUR’s, expedited safety reports, proprietary name requests, Clinical Study Plans & Protocols, responses to questions/information requests from health authorities) and assists in the preparation of briefing documents for milestone development meetings with regulatory agencies.
- Supports the preparation of PMA’s and international marketing applications
- Provides strategic input on the US and global regulatory strategy
- Provides regulatory support for clinical and preclinical drug/device development activities (e.g., reviews clinical trial documents including clinical protocols, Clinical Report Forms and study reports, Investigator Brochures, Informed Consent Forms, nonclinical protocols and reports, reviews and approves clinical development plans, clinical trial material manufacturing plans and labeling, and other essential documents related to clinical trials).
- In charge of the maintenance and compliance of Clinicaltrials.gov. registrations.
- Applies knowledge of key guidance documents, regulations, or directives and effectively communicates any impact on product development programs and regulatory filings.
- Coordinates with cross-functional teams and interfaces with contractors, vendors, and consultants to define requirements for regulatory submissions.
- Liaises with other Regulatory Affairs functions (QA, Regulatory CMC, Operations/Documentation, and Compliance) to develop and manage timelines for the preparation of assigned regulatory filings.
- Bachelor’s degree (B.A. /B.S.) in Biology, Chemistry, Biochemistry, or related discipline
- 5+ years of direct experience in Regulatory/Clinical Affairs for combination products or medical devices.
- Must have experience in preparing FDA pre-submissions, IDEs and INDs in (CTD format a Plus)
- Knowledge of FDA and ICH guidelines for drug development as well as regulatory requirements for clinical trials, investigational drugs, and marketing applications
- Strong technical writing ability
- Knowledge of Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs), and Good Manufacturing Practices (GMPs)
- Certified CRA preferred
- Proficiency in Microsoft Office (Word, Excel, Outlook)
- Ability to work in office setting
- Ability to travel to clinical sites and partner sites (domestic and international)
- Preferred location is Maryland at the Theradaptive Laboratories/DC Beltway but will consider remote work
- Clinical and Regulatory Affairs
Theradaptive is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, ethnic or national origin, ancestry, pregnancy (including childbirth or related condition), citizenship, familial status, mental or physical disability, veteran status, genetic information, other non-disqualifying disability, or any other characteristic protected by law.