Manager, Regulatory Affairs at Iovance Biotherapeutics | chakrie

Requirements

Additional Requirements

BA/BS degree in related field required
8+ years’ experience in regulatory affairs or a related function in drug/biologic development and a Bachelor’s degree, 6+ years with a Master’s degree, or 4+ years with a PhD.
Experience in managing regulatory submissions for investigational or marketed products to global health authorities in eCTD format
Broad understanding of international regulations and procedures in drug/biologics development; familiarity with ICH and regional regulatory requirements.
Organizational and planning skills; ability to influence and negotiate professionally at various levels within the project team and with external partners while maintaining positive working relationships.
Advanced skills in using Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat Pro.
High attention to detail and accuracy.
Excellent interpersonal, verbal and written communication skills.
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
Advanced degree preferred (or relevant experience).
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.
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
ability to handle multiple priorities simultaneously
This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.
The annual base salary we reasonably expect to pay is listed. Individual pay decisions depend on various factors
complexity and responsibility of the role
experience and skills.
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
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
and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities
please contact .
By voluntarily providing information and clicking “Submit Application”
you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.

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Salary & benefits

A clear overview of what is expected, written by the people who posted it, with every detail you need to decide.

Qualifications, experience and the skills that matter most, along with anything that would make you stand out.

Practical next steps, the documents to prepare and the dates to keep in mind before you apply or get in touch.

Contact details, links to the official source and the notes our team adds after checking each listing by hand.

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Manager, Regulatory Affairs

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Requirements

Additional Requirements

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Additional Requirements

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