Director of Regulatory Affairs - Clinical Research Organization
Our client is a well-established, growing Clinical Research Organization (CRO), located in the DC/Maryland area suburbs. We are seeking a Head of Regulatory Affairs and Strategy to join their growing team. Our client does offer a highly competitive salary and benefits program, as well as opportunities for career development and advancement.
Director of Regulatory Affairs Primary Purpose
The Director of Regulatory Affairs is responsible for leading strategy and directing staff for a 25 person Regulatory Affairs Department within this active CRO providing cutting edge clinical trials within drug development and biologics. This position reports to the Chief Medical Director and will have full responsibility for all Regulatory Affairs Strategy, Compliance and Document Management, providing overall expert input and oversight of regulatory activities, including, but not limited to, the content and presentation of documents for submission to, and subject to inspection by, Competent Regulatory Authorities world-wide.
Director of Regulatory Affairs Responsibilities:
Lead the cross-functional teams to advise on the most appropriate regulatory strategy given the goals of the development program, anticipated timelines, and the regulatory landscape. Anticipate, identify, prioritize, and mitigate regulatory risks while ensuring compliance with global regulatory requirements
Oversee junior staff members involved in the planning, authoring, compiling and submission of highest-quality regulatory applications to Competent Regulatory Authorities world-wide, within company timelines and in accordance with regulatory guidelines and applicable local/international laws
Works on and solves increasingly complex projects/problems where analysis of the situation or data requires evaluation of some intangible factors
Oversee the drafting, review, and approval of key regulatory documents including but not limited to Meeting Requests and Briefing Packages, Initial IND/CTA Applications, Annual Reports, and Information Amendments. Lead the development and drafting of key strategy documents including Breakthrough, Fast Track, and Orphan Drug designation application
Direct interactions with regulatory agencies on defined matters
Recommends strategies for earliest possible approvals of clinical trials applications. Provides guidance on interpretation and application of specified regulations
Provide expert analysis and advice for the requirements for the design, conduct, and presentation of non-clinical studies that support the development of basic research candidates into clinical stage testing and development to marketing authorization
The design/oversight of IND enabling non-clinical studies, including toxicology, pharmacology, metabolism, and pharmacokinetic studies
Expertise regarding the GLP requirements for the conduct (possibly via inspection) and reporting of non-clinical studies
Provide expertise and input to project teams regarding the cGMP requirements for the sourcing, manufacture and release of investigational and marketed drugs, devices and biologics for use in clinical studies
Perform external cGMP audits in support of the supplier evaluation program to identify and evaluate all risks given project scope
Review batch records and product release data for compliance with the applicable regulations and the suitability to support the clinical program
Provide expertise regarding GCP compliance, both internally at Emmes and externally at clinical sites and third party vendors
Regulatory agency inspection support, including sponsor/monitor inspections and clinical investigator site inspections
GCP compliance audits of investigator sites, CRO facilities, and vendors, including GLP clinical sample labs and GMP audits at clinical pharmacies
Provide team training regarding GLP, GMP, GCP, etc., and the development and maintenance of GXP-related quality systems. Coach and direct team to produce excellent work, providing development opportunities for team to reach their full potential
Director of Regulatory Affairs Experience Desired:
PharmD or PhD in a scientific discipline, preferred along with at least 10 years of relevant experience in Regulatory Affairs. BS/MS requires 10-12 years of relevant work experience in Regulatory Affairs or 15+ years of experience with a BS only
RAC Certification preferred, International RAC preferred
Must have in-depth knowledge of U.S. FDA and International regulations, guidance documents, and regulatory process pertaining to drug development, clinical testing and approval, inclusive of CMC, clinical and non-clinical requirements / dossier content and presentation
Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities and overseeing indirectly Document Management and the start up of Veeva Vault.
Possesses advanced analytical skills with the ability to interpret data/information and its practical application
Demonstrates in-depth knowledge and understanding of FDA guidelines, and both federal and international regulations / guidelines with demonstrated ability to successfully apply these to a compliant work output
Preferred candidates will have experience working in Regulatory Affairs across two or more geographic areas, and demonstrate proven skill at contributing to, developing, and/or implementing successful global regulatory strategies
Working knowledge of GCP and TMF governing regulations, such as the TMF Reference Model
Basic understanding of records management best practices and core requirements and in Drug Development
Experience evaluating and utilizing third party document sharing tools, such as LiveLink, FileNet, etc.
Experience in NIH-sponsored clinical programs a plus
Experience in line-management and/or mentoring less experienced Regulatory Affairs staff
Strategic thinking, leadership skills, assertiveness, strong technical background, good business judgment, integrity, and excellent negotiation and project management skills as evidenced by past performance on drug development project teams
Thorough understanding of electronic submissions for ICH/FDA compliance to electronic Common Technical Document (eCTD) standards
Excellent organizational, planning, analytical, and problem solving skills. Attention to detail required
Ability to build and maintain positive relationships with management, peers, and subordinates. Effectively communicates regulatory requirements and strategies as they affect regulatory submissions to internal and external partners
Excellent verbal and written presentation and communication skills are necessary. Highly motivated, results driven with unyielding predisposition to detail, accuracy and clarity.
Performs duties with the highest ethical standards, delivering only high-quality, compliant submissions to FDA
Consistently exercises sound judgement and effectively prioritizes competing tasks in a fast-paced and dynamic environment
Possess high degree of initiative and the ability to work independently
Sound knowledge in MS Office (Word, Excel, and PowerPoint) and PDF rendering tools
Experience in the areas of Infectious Diseases, Cellular Therapies, Ophthalmology Medicine, Substance Use Disorders, and/or Child and Maternal Health is a plus
Internal Number: jhkg1
About Well established CRO
Apple & Associates is an executive search firm that specializes in the Pharmaceutical, Consumer Products and Medical Device 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. We are a nation-wide company with offices in Alabama, South Carolina, Florida, California, Minnesota and Virginia.
Apple & Associates belongs to Intercity Personnel Associates (IPA), the Top Echelon Network and First Interview. Through these worldwide recruiting networks, we share confidentially coded information about available positions and receive qualified candidates within a short period of time. With one phone call you not only have rapid access to our candidates, but also to qualified candidates from over 1,000 of the nation’s other top recruiting firms. Because our executive recruiters specialize in different industry segments, we can give you the service you deserve in a fast, focused, and efficient manner and provide you with quality industry specific candidates.
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, Consumer Products and Medical Device industries so successful. Our candidates will meet the standard your company demands, with the technical and industry background to match.