Associate Director Director of Regulatory Affairs (Maryland)

Associate Director Director of Regulatory Affairs

The Associate Director Director of Regulatory Affairs will be responsible for managing regulatory aspects of pharmaceutical programs in various stages of development. This person will ensure that all details are managed efficiently and will have direct experience preparing regulatory submissions for pharmaceutical products. Key areas of responsibility include Coordinates and prepares document packages for regulatory submissions. Compiles all materials required in submissions license renewal and annual registrations. Recommends changes for labeling manufacturing marketing and clinical protocols for regulatory compliance. Ensures accuracy and quality of regulatory submissions generates and or review regulatory documents to ensure appropriateness with regulatory requirements agreements and regulations. Reviews Federal Register and rest of world regulatory notices websites and keeps abreast of regulatory procedures and changes. With supervision may direct interaction with regulatory agencies on defined matters. Independently represents department on assigned projects. Translates domestic and foreign regulatory requirements and provides guidance in a manner that effectively facilitates team decision making on development programs. influence overall business strategy and decisions and drive business impact. Position Requirements Successful candidates will have the following background experience Needs to have at least a MS Degree with a focus in a science- or health-related discipline with a minimum of 5 years pharmaceutical industry or related experience in the regulatory affairs environment. Solid background in the biological sciences and the ability to apply that knowledge to complex drug development issues within the framework of applicable regulatory requirements. High-level of proficiency in generating clear and concise submissions to health authorities. Strong knowledge of US regulations including knowledge of GCP GLP and cGMP. Experience with all types of submissions including INDs NDA MAAs CTD and supplements. Ex-US submission experience preferred. Strong written and verbal communication skills including effective negotiation techniques. Highly productive team member capable of making insightful contributions and influencing decision making. Client offers a competitive compensation package with excellent benefits and a 401(k) matching program. An equal opportunity employer committed to the hiring advancement and fair treatment of individuals without regard to race color religion sex sexual preference age national origin ethnicity disability or any other protected status designated by law. Applicants should submit a cover letter with their Curriculum Vitae or Resume CB Staffing Solutions LLC Kensington MD