Manager, Regulatory Affairs CMC

Reasonable accommodations may be made upon request to enable individuals to perform essential functions.

$170,000

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$195,000 USD

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

Works closely with functional leaders to 1) create the optimal development path for Iovance product candidates, 2) negotiate optimal development paths within internal cross-functional teams and with health authorities, 3) execute clinical-regulatory development plans on-time and while managing all identified risks.

Collaborates with RA CMC Product Lead to execute CMC Submission and Authoring strategy for assigned project.

Ensures that evolving global regulations, guidelines and health authority expectations, especially those related to cell therapies, are incorporated into program decision making.

Assures that standardized practices are implemented and maintained across regulatory documents.

Collaborates with Regulatory Operations to ensure timely and accurate submissions

Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics