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.
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
- 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.