Manager, Regulatory Affairs

DescriptionThe Manager, Regulatory Affairs will support planning and executing regulatory document preparation for US and Global regulatory submissions. Position will keep abreast of evolving regulatory procedures and practices.

Responsibilities:Represent Regulatory function in assigned Study TeamsManage and prepare Clinical Trial Applications (CTA) for particular studies when included in the project scope.Manage the creation, review, and submission of CTA regulatory documents to support globally.Collect reports and documentation and coordinate the content and format of CTA submissions according to health authority requirements.Create regulatory submissions from internal reports.Maintain current knowledge of relevant domestic and international guidance’s, laws and regulations, and proposed and final rules which affect ophthalmology drug or medical device development.Ensure regulatory guidance documents and laws, as well as internal policies and procedures, are followed to ensure regulatory compliance is maintained.Review regulatory agency submission materials to ensure timeliness, accuracy, completeness, and compliance with regulatory standards.Ensure that dossiers containing quality, preclinical, and clinical data are presented clearly and succinctly to optimize the regulatory review and approval process.Ability to read and understand all components of a regulatory submission (CTA/MAA) to ensure consistency across documents.Coordinate the preparation of responses to questions and inquiries from Health Authorities. Prepare and submit CTA amendments in accordance with regulatory submission schedules and regulations.Works with regulatory affairs /service providers on CTA submissions as applicable.Represents Regulatory Affairs at cross-functional study team meetings.Ensure preparation of dossiers containing preclinical, clinical, and quality data in the required eCTD format.Ensure accurate retention in the archival system of all regulatory submissions and contacts with health authorities.Contribute positively to a strong culture of business integrity and ethics. Remain current with evolving regulatory procedures and practices, and provide guidance to project teams.Act within compliance and legal requirements as well as within company guidelines.

Supervisor Responsibilities:Line management responsibilities for staff members. For direct and indirect reports, I may participate, and direct activities related to department staff operations such as interviewing and selection, professional development, performance management, and employee counseling and separations. Approves courses of action on salary administration, interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counseling. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.Performs other work-related duties as assigned.Minimal travel may be required (up to 25%).

RequirementsEducation:Required: Bachelor’s degree in life sciences or related field.

Experience:Minimum of 3+ years of regulatory or drug development experience.

Skills:Project management and interpersonal skills is a requirement, as well as excellent written and verbal communication abilityExperience in FDA, EU-CTR and CTIS process, and experience or willingness to learn processes for other relevant global regulatory bodiesExperience in the UK CWoWExcellent communication skills; both oral and written.Demonstrated ability to contribute to a continuous learning and process improvement environment.Excellent analytical and organizational skills and ability to support multiple projects in a timeline-driven environment.Experience with document management systems, eCTD submissions managing, and maintaining regulatory files preferred.

Physical Requirements:Position requires: ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. The noise level in the work environment is low.

Disclaimer:Tasks, duties, and responsibilities as listed in this job description are not exhaustive. Lexitas Pharma Services, Inc., at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. Lexitas Pharma Services, Inc., at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.