Our client is a well-established Clinical Research Organization, experiencing significant growth!! This position may be located in Rockville or Frederick, Maryland
The Senior Regulatory Affairs Specialist is responsible for functioning as the regulatory lead on integrated project teams, and as a mentor within the Regulatory Affairs group. The Senior Regulatory Affairs Specialist contributes to corporate initiatives, interacting with clients, and ensuring accuracy, completeness and compliance of high-quality submissions to US and international regulatory authorities, from pre-submission phase through market launch.
- Leads development of regulatory strategies to advance new drugs, biologics and combination products through the investigational studies and approval process, including initial preclinical and CMC support, pre-submission assistance (e.g. INTERACT and pre-IND meetings), application submission and maintenance (e.g. IND, CTA), applicability of accelerated approval pathways, competent authority and advisory committee meetings, and drafting and review of marketing applications (NDA, BLA, etc.)
- Provides strategies for milestone regulatory applications, including orphan drug designation, breakthrough designation, RMAT, compassionate use applications, and investigational products for pediatric populations
- Performs targeted gap analyses, highlighting pertinent regulatory considerations based on knowledge of regulations, guidance documents, and predicate product approval
- Participates in development and review of critical regulatory documentation including Investigator Brochures, nonclinical and clinical data summaries, and manufacturing information
- Prepares and/or reviews regulatory submissions, filing amendments and correspondence with the regulatory authorities, including Annual Reports
- Applies project management skills for timely submission of investigational product applications, collaborating with both internal and external stakeholders
- Tracks regulatory deliverables, and communicates status to project team and external stakeholders
- Provides input to project and functional teams on regulatory issues regarding clinical trial conduct and the status of regulatory filings
- Mentors team members, and represents regulatory affairs to functional and service groups
- Assists in developing proposals for new clients and re-bid processes for current clients
- Participates in project process improvement and corporate initiatives as appropriate
- Maintains knowledge of current applicable regulations, guidance documents, competent authority product approvals
- MS or PhD in regulatory affairs or a scientific discipline, or equivalent experience; combination of training and experience will be taken under consideration
- Five years’ minimum experience as a Regulatory Associate or Regulatory Specialist
- Working knowledge and understanding of ICH, GCP and relevant regulatory agency requirements domestically and internationally, including pending and recently approved regulations
- Three years (minimum) of direct experience in submissions to competent authorities, with emphasis on the FDA,and experience in evaluating scientific data and reports
- Knowledge of Common Technical Document (CTD) submission format
- Experience with direct quality and version control of documents
- Organized, detail oriented, and excellent written and oral communication skills
- Work independently, functioning within a multidisciplinary team environment
- Excellent skills in prioritization, problem solving, organization, decision-making, time management
- Strong skills in MS Word, Excel, and Outlook, as well as project management software
- Regulatory Affairs Certification (RAC; US and additional regions) or equivalent
- Experience with HHS- and Industry-funded clinical studies
- Experience with advanced biological products
- Experience with international submissions and medical devices (domestic and international)
- Experience with non-clinical studies and GLP requirements
Provide Actionable Feedback
Prepare Regulatory Submission
Provide Regulatory Support
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