Overview
Iovance seeks a highly motivated Regulatory Operations Specialist. The successful candidate has experience planning and managing regulatory authority submissions. The Specialist will ensure the compilation of compliant and timely regulatory submissions in eCTD format to regulatory authorities. Attention to detail in written correspondence and in the maintenance of regulatory files are essential factors for success in this role, as is the ability to work with diverse internal and external customers. The position will report to the Manager Regulatory Operations and work with other Regulatory Affairs team members to support submissions and department goals.
Essential Functions and Responsibilities
* Responsible for submission planning, oversight of publishing vendor, QC, and transmitting published output to FDA and regulatory authorities within other countries, followed by archiving the published output.
* Works with submission authors and reviewers to ensure that source document planning is complete and that high-quality documents are approved on schedule.
* Ensures that all submissions to, and correspondence from, regulatory authorities are archived and tracked.
* Ensures that commitments to regulatory authorities (i.e., responses to information requests) are planned, tracked, and delivered on schedule.
* Represents Regulatory Affairs on cross-functional regulatory submission and clinical study management teams.
* Participates in implementing new regulatory agency guidelines and rules relevant to company submissions.
* Participates in department projects that improve the department systems and processes.
* Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
* Perform miscellaneous duties as assigned.
Required Education, Skills, and Knowledge
* Bachelor of Science degree in a relevant scientific or life sciences discipline required (or equivalent in experience)
* Minimum 2 years of Regulatory Affairs Operations experience
* Experience in managing and publishing regulatory submissions for investigational or marketed products to global regulatory authorities in eCTD format
* Experience with ex-US submissions (i.e MAA, MHRA, TGA, and Swissmedic)
* Knowledge of industry standards, regulations, and guidelines related to regulatory submissions.
* Strong organizational skills with attention to detail
* Strong verbal and written communication skills
* Ability to work independently with minimal supervision or direction
* Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
Preferred Education, Skills, and Knowledge
* Strong working knowledge of Microsoft Word (Starting Point), publishing software (docuBridge), and Veeva Vault RIM preferred.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions.
Physical Demands and Activities Required
* Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
* Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
* Must have visual acuity to perform activities such as preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
* This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
* Must be able to communicate with others to exchange information.
Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.
Work Environment
This job operates in a professional workplace or remote office environment and requires standard office equipment and keyboards. Employees who work remotely are expected to maintain their workspace and environment safely and free from safety hazards.
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.
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