Overview
Iovance seeks a highly motivated Senior Regulatory Affairs Specialist/Regulatory PM coordinator. The successful candidate has experience planning and managing regulatory authority submissions. He / She will coordinate CMC submissions across multiple products, supporting management of the planning, compilation, QC, and submission of CMC dossier content to clinical and commercial applications, and their amendments. This role will be responsible for the preparation and adaptation of submission documents for use in global clinical and commercial submissions following eCTD specifications and market specific requirements and may be responsible for independently planning and preparing routine clinical trial application related amendments and commercial submissions (e.g. Annual reports, DSUR, health authority queries). An important aspect of this role is the planning and management of submissions. Attention to detail in written correspondence, in the maintenance of regulatory files, and ability to work with diverse internal and external stakeholders are also important factors for success in this role. Another important aspect of this role is the capacity to contribute to the development and execution of optimal CMC life cycle management of clinical and commercial products, with an emphasis on change management.
Essential Functions and Responsibilities
- Support management of the planning, compilation, QC, and submission of CMC dossier content to clinical and commercial applications, and their amendments.
- Prepare and adapt submission documents for use in global clinical and commercial submissions following eCTD specifications and market specific requirements.
- May be responsible for independently planning and preparing routine clinical trial application related amendments and commercial submissions (e.g. Annual reports, DSUR, health authority queries).
- Independently manages submission trackers for coordination of submissions across multiple products.
- Maintains logs of clinical and commercial submissions and correspondence with FDA or other regulatory agencies.
- Facilitate communication with Vendors/ CROs for planning and tracking of source documents to ensure high-quality IND, IND amendments, CTA, EU-CTR submissions are delivered in timely manner.
- Support the implementation of regulatory strategy for assigned projects and programs for projects in all stages of development (IND through NDA/BLA approval and commercialization).
- Works with submission authors and reviewers to ensure that source document planning is complete and that high-quality documents are approved on-schedule in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes.
- Prepare and compile effective presentations for external and internal audiences as needed.
- Create documents in accordance with eCTD specifications.
- Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
- Perform miscellaneous duties as assigned.
Required Education, Skills, and Knowledge
- BS degree required; advanced degree (PharmD, PhD, Master’s) preferred.
- Strong scientific or research background, with a focus in pharmacy, chemistry, or biology, preferred (or relevant experience).
- Minimum 5 years’ experience in regulatory affairs or a related function in drug/biologic development.
- Experience in managing regulatory submissions for investigational or marketed products to global health authorities in eCTD format a plus.
- Understanding of US, and Ex-US including international regulations and procedures in drug/biologics development; familiarity with ICH and regional regulatory requirements.
- Familiarity with ICH eCTD structure, knowledge of major market post approval change requirements, and ability to assess impact to CMC content clinical and commercial applications.
- Advanced skills in using Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat Pro.
- High attention to detail and accuracy.
- Excellent written skills and the ability to form defensible arguments based on data, literature references, industry standards, and country regulations/guidelines.
- Excellent organizational and planning skills is a requirement.
- High level of motivation and proactiveness required to engage in both in-person and remote team members
- Excellent interpersonal, verbal and written communication skills
- Ability to work both independently and collaboratively as part of a team.
- Comfortable in a fast-paced small company environment with ability to adjust workload based upon changing priorities.
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. Please contact Human Resources to request an accommodation.
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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