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Senior Regulatory Affairs Specialist

Apple & Associates Rockville Full-Time
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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.

Responsibilities

  • 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

Experience

  • 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

Desirable Experience

  • 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

Recommended skills

Non Disclosure Agreement (Intellectual Property Law)
Biologics License Applications (Bla)
Good Clinical Practices (Gcp)
Decision Making
Complex Problem Solving
Multitasking
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Apple & Associates is an executive search firm that specializes in the Pharmaceutical, Medical Device, Biotech, Consumer Products, Manufacturing, Banking, Plastics and Rubber Industries. We provide extensive coverage of these worldwide markets and have forged a solid reputation in the industry as a competent, aggressive, and resource-rich recruiting firm. Apple & Associates is a nation-wide employment search company. We belong to Top Echelon Network, Inc. and Intercity Personnel Associates (IPA), large recruiting networks with several hundred search firms' each from around the country. Through these networks, we can share confidentially coded information about a job and receive qualified candidates within a short period of time. The advantage for you is that with one phone call you not only have rapid access to our candidates, but also to several hundred recruiting firm’s industry specific resources and candidates. Because our executive recruiters specialize in different industry segments, we can give you the service you deserve in a fast, focused, and efficient manner. We realize the importance of hiring professionals who understand and are able to assimilate with your company’s business model, culture, process, equipment, and materials. Our team has studied the hiring decisions that make the firms in the Pharmaceutical and Medical Device industries so successful. Our candidates will meet the standard your company is striving for, with the technical and industry background to match.

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