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Roivant Sciences // biomedical research
 
Roivant Sciences, 151 West 42nd Street, 15th Floor, New York City 10036    Posted: Wednesday, September 22, 2021
 
   
 
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JOB DETAILS
 

Roivants mission is to systematically reduce the time, cost, & risk of delivering new medicines to market by accelerating the development of promising drug candidates to improve the lives of patients & their families. Since its inception in 2014 Roivant has achieved the following critical milestones in support of its vision:  launched over 20 portfolio companies (Vants); 5 successful IPOs; $3B partnership with global pharma; pipeline of over 40 assets across various modalities & therapeutic areas; 8 successful phase 3 readouts since 2019.  Building upon this track record of establishing a robust pipeline through in-licensing & acquisition of novel assets & technology platforms, Roivant is currently building new capabilities in drug discovery & expanding upon existing development disciplines to become the first large tech-enabled pharmaceutical company.

As the centralized engine for innovation & development the Roivant R&D team is responsible for: 1) discovery efforts focused on integrating computational & medicinal chemistry methods in order to establish R&D leadership positions in oncology, immunology & rare diseases; 2) working hand in hand with Business Development to establish the scientific rationale & initial development strategy for in-licensing opportunities; 3) providing tactical & strategic R&D support to stand up new portfolio companies (Vants) & advance development efforts across the portfolio. 

Position Summary: 

The Director of Regulatory Operations will be responsible for managing the regulatory operations infrastructure & overseeing with the regulatory publishing & document management needs for Roivant Sciences. This position in consultation & alignment with the VP of regulatory affairs is accountable for all regulatory operations activities for the programs Roivant regulatory supports. This includes document archiving, submissions planning, publishing, QC, & submissions. The role will require direct hands-on contributions, as well as establishing a regulatory operations team over time. S/he will be a senior member of the Roivant regulatory leadership team. A successful candidate must have significant experience handling all types of regulatory submissions from early phase through post-approval. US FDA experience is essential, global experience is strongly preferred.

Responsibilities:

  • In consultation with the VP of regulatory affairs, establish the regulatory operations infrastructure & teams.
  • Able & willing to do hands on regulatory publishing.
  • Responsible for all submissions to be error free from a regulatory validation standpoint & are submitted on time to meet any internal or external requirements.
  • Responsible & accountable for implementing SOPs & work processes for publishing, submissions & archiving in collaboration with Roivant Quality.
  • Works with regulatory strategists & CMC strategists & project team members to execute the regulatory submissions strategy.
  • Works with the Roivant Quality on alignment of regulatory infrastructure with organizational operational infrastructure.
  • Leads & mentors junior level regulatory associates.
  • Works closely with regulatory strategists & Quality team to insure regulatory infrastructure is always current, up to date & inspection ready.
  • Establishes & oversees the regulatory operations group.

Requirements:

  • BA/BS degree required with 10+ years of pharmaceutical industry experience with 7+ years in regulatory affairs
  • Experience working with the FDA is required. Additional experience with ex-US is preferred.
  • Must be solution oriented.
  • Must be able to handle all aspects of regulatory operations.
  • Have successfully completed IND & NDA/BLA submissions activities. Preferred if also handled medical device submissions & post-approval activities.
  • Highly collaborative team player who fosters open communication & facilitates mutual understanding & cooperation between all stakeholders.
  • Excellent verbal & written skills, allowing for an open & effective dialogue throughout the company.
  • Must be able to command respect from peers & capable of highly independent work as well as being a team player & role model.
  • Must be a highly motivated, decisive, & results-oriented individual with the flexibility & creativity to excel in & contribute to a rapidly growing company.
 
 
 
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