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 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.
- 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.
- 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.