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About our client
Our client is a rapidly growing biotech company headquartered in Maryland that is focused on the development and commercialization of various therapeutics for disorders of the nervous system. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees.
Position	Location
Associate/Director of Regulatory Affairs	Maryland
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Manage all regulatory aspects on pharmaceutical programs in various stages of development 2) Ensure that all details are managed efficiently and will have direct experience preparing regulatory submissions for development products 3) Represent department on assigned projects, make decisions outside the functional group on development programs 4) Translate domestic and foreign regulatory requirements 5) Provide guidance in a manner that effectively facilitates team decision-making on development programs 6) Manage, prepare and ensure the timely submission of well-organized and scientifically sound regulatory submissions 7) Maintain awareness of changes in regulatory requirements for effective submissions 8) Ensure accuracy and quality of regulatory submissions 9) Generate and/or review regulatory documents to ensure appropriateness with regulatory requirements, agreements and regulations 10) Serve as regulatory liaison with the FDA and other regulatory agencies for assigned projects 11) Interpret and execute policies and plans affecting the department and assigned projects
Requirements
1) Ph. D., M.D. or Pharm. D. degree with a focus in science or health-related discipline; Masters (MBA preferred) 2) Minimum 6 years of pharmaceutical industry or related experience in the pharmaceutical regulatory affairs environment 3) 3+ years of experience in people management in regulatory affairs 4) Experience as lead RA person in IND and NDA submissions (at least 2 of each) 5) Experienced in all types of submissions, including INDs, NDAs, CTD and supplements 6) Solid background in General Biological/Physical Science 7) Ability to apply that knowledge to complex drug development issues within the framework of applicable regulatory requirements 8) Strong knowledge of US regulations, including knowledge of GCP, GLP and cGMP 9) High-level proficiency in generating clear and concise submissions to health authorities 10) Track record in establishing effective FDA interactions that result in a partnership with the corporate development team 11) Highly productive team member, capable of making insightful contributions and influencing decision-making 12) Strong written and verbal communication skills, including effective negotiation techniques