Associate Director, Regulatory Operations
Company: Spero Therapeutics
Location: Cambridge
Posted on: April 9, 2021
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Job Description:
Associate Director, Regulatory Operations Spero Therapeutics
(Nasdaq: SPRO) is a multi-asset clinical stage biopharmaceutical
company in Cambridge, Mass. We are highly committed to advancing
novel treatment approaches for bacterial infections with a
world-class team of biotechnological and biopharmaceutical experts.
The company has a pipeline of novel and highly differentiated
antibacterial and rare disease product candidates focused on the
unmet needs of patients with multi-drug resistant (MDR) bacterial
infections. Spero's lead product candidate, Tebipenem HBr, is an
oral carbapenem currently being evaluated in a pivotal Phase 3
clinical trial for the treatment of complicated urinary tract
infections. Spero is also advancing SPR720, its oral antimicrobial
agent in development for the treatment of nontuberculous
mycobacterial (NTM) pulmonary disease, a rare orphan disease.
Spero's third product candidate, SPR206, is an IV-administered
agent being developed as an innovative option to treat MDR
Gram-negative bacterial infections. We sincerely believe that our
novel product candidates will have meaningful impact on patient
health and significant commercial applications for the treatment of
MDR infections in both the hospital and community settings. NOTE:
This position is currently remote and we will consider candidates
who are within a reasonable travel distance to our Cambridge, MA
headquarters--but who reside in other states, with the expectation
that there will be periodic travel to MA. General Scope and Summary
of Role Spero Therapeutics is looking for a collaborative,
enthusiastic, experienced, hands-on partner responsible for leading
the development and implementation of a robust Regulatory
Operations function. This includes development of policies and
processes for multiple products including the preparation of
compliant submission-relevant documents relating to company's
development activities for a growing company in the US and other
countries.
-- What You'll Do:
What You'll Need:
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Keywords: Spero Therapeutics, Cambridge , Associate Director, Regulatory Operations, Executive , Cambridge, Massachusetts
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