Associate Director, Regulatory Affairs & Strategy
Posted on Nov 13, 2018 by EMMES Corporation
The Emmes Corporation, established in 1977, is a privately-owned Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.
Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.
The Associate Director, Regulatory Affairs & Strategy Support is responsible for 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.
- Work with 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
- PharmD or PhD in a scientific discipline, preferred along with at least 5 to 7 years of relevant experience in Regulatory Affairs. BS/MS requires 8 to 10 years of relevant work experience in Regulatory Affairs or 10+ years of experience with a BS only RAC Certification 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 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
Emmes has an outstanding benefits package including: generous tuition reimbursement, professional development and training programs
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The EMMES Corporation is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.
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