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Roivant Sciences // biomedical research
 
Roivant Sciences, 151 West 42nd Street, 15th Floor, New York City 10036    Posted: Saturday, May 29, 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 Senior Director of regulatory strategy will be the regulatory lead for specific assigned programs within Roivant Sciences.  This position in consultation & alignment with the VP of regulatory affairs is accountable for developing & executing the regulatory strategy for the program.  S/he will work closely with the functional area subject matter experts, regulatory CMC lead & regulatory operations to execute all regulatory activities.  The role will require direct hands-on contributions, as well as oversight of the growth & supervision of the more junior level regulatory associates. S/he will be a senior member of the Roivant regulatory leadership team.  A successful candidate must have significant experience in early phase of drug development.  Experience in late phase development & both small molecule & biologics is preferred.  US FDA experience is essential, global experience preferred.  Must have led regulatory agency meetings

Responsibilities: 

  • In consultation with the VP of regulatory affairs, develop the regulatory strategy for assigned projects at early stages of development, in collaboration with cross-functional members
  • Functions as the regulatory point of contact both for the project team & within the US as the regulatory liaison to the FDA.
  • Responsible for executing the regulatory strategy for the program, which may include preIND, EOP1, EOP2, IND, CTA, IMPD, NDA, BLA, orphan designations, fast track designation, & breakthrough designation filings.
  • Responsible & accountable for insuring all regulatory commitments are fulfilled on time & accurately, including but not limited to annual reports, DSURs, PSURs, safety submissions, PMRs, etc.
  • Works with regulatory CMC & operations & functional area subject matter experts to execute the regulatory strategy.
  • Handle in licensing due diligence
  • Plans, prepares & leads regulatory agency meetings.
  • Provides regulatory assessment & gap analysis for due diligence activities.
  • Leads & mentors junior level regulatory associates.
  • Therapeutic area experience in oncology, rheumatology, & infectious disease is preferred.
  • Works closely with operations team to insure regulatory infrastructure is always current, up to date & inspection ready.
  • Keeps up to date on changing regulatory landscape.

Skills, Qualifications, & Requirements: 

  • PhD, MD, PharmD or advanced scientific degree is preferred.
  • 10+ years of pharmaceutical industry experience with 7+ years in regulatory affairs
  • Experience working with the FDA is required. Additional experience with EU, Japan and/or China is preferred.
  • Must be solution oriented.
  • Must have prepared for & led regulatory agency meetings
  • Have successfully developed & completed preIND & IND submissions activities. Preferred if also developed & completed NDA/BLA submissions & post-approval activities.
  • Must have novel small molecule experience. Preferred if also has biologics experience.
  • Global regulatory clinical trial experience is essential. This needs to include first in man studies.  Preferred if experience also includes later stage & pivotal registration studies.
  • 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.
  • Requires proven ability to manage multiple projects.
 
 
 
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