[Hiring] Senior Associate, Regulatory Affairs CMC @Iovance Biotherapeutics

Role Description

The Senior Associate, Regulatory Affairs CMC will participate in the planning and managing regulatory authority submissions. They 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.

• Independently plans and prepares routine clinical trial application related amendments and commercial submissions (e.g. Annual reports, DSUR, health authority queries).
• 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.
• Facilitates 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 a timely manner.
• Supports 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.
• Prepares and compiles effective presentations for external and internal audiences as needed.
• Creates documents in accordance with eCTD specifications.
• Adheres to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Performs miscellaneous duties as assigned.

Qualifications

• 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).
• 8 years’ experience in regulatory affairs or a related function in drug/biologic development with a bachelor’s degree, 6+ years’ experience with a master’s degree, or 3+ years with a PhD.
• 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.

Requirements

• 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.

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.

Pay Transparency

The annual base salary we reasonably expect to pay is listed. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of the role, job duties/requirements, and relevant education, experience and skills.

• $140,000 — $160,000 USD

Company Description

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.