Dermavant Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies for inflammatory skin diseases and medical dermatologic conditions. We are passionate and dedicated to realizing the full potential of biomedical research and to developing and commercializing novel first-in-class or best-in-class therapies that improve patients’ lives. The patient is at the heart of everything we do.
The Director Global Regulatory Affairs is responsible for overseeing and executing regulatory affairs activities for specific drug development programs and/or regulatory deliverables on any program as assigned. This individual will work collaboratively to develop and implement regulatory strategies. This individual may be responsible for overseeing peri/post-approval regulatory activities to enable efficient achievement of corporate and commercial goals. Oversight of specialized regulatory areas such as labeling, advertising/promotions, and/or regulatory intelligence are responsibilities that may be assigned dependent on growth. This is a hands-on position and requires ability to both think strategically and execute operationally with excellence.
- Development and review of regulatory strategies and regulatory execution in support of multiple assets.
- Preparation and review of regulatory submissions for assigned programs, including IND/NDA eCTD module development, preparation and review in context of target product profile and key messages.
- Critical review of regulatory and clinical documents, including but not limited to: protocols, investigator brochures, informed consents, clinical trial registration/postings, clinical study reports, labeling and related documents.
- Oversee and/or prepare regulatory presentations for internal and/or partnership governance/alliance meetings
- Regulatory representative for due diligence activities as assigned.
- As a member of the global regulatory team, be a driver and contributor to regulatory initiatives to improve strategic capabilities and operational excellence
- As a leader of the global regulatory team, coach and mentor other Regulatory Affairs staff to share knowledge and expertise in assigned areas
- Establish a network of internal stakeholders and develop a close working relationship with subject matter experts and contributors to ensure that Regulatory Affairs is recognized as a valued strategic partner in the development and commercialization of products
- Accept regulatory accountability globally for a program, working with the Global Regulatory Team (Regulatory Regions [partners], Regulatory CMC, Regulatory Operations, Regulatory Labeling) for developing and executing robust regulatory strategies.
- Master’s degree in Life Sciences, PharmD or PhD desirable
- At least 10 years of industry experience working in regulatory affairs (US or globally).
- Management experience of a small team is a plus
- Experience with both early and late stage development projects is required and experience with marketed products is preferred
- Prior experience in the Dermatology therapeutic area is preferred
- FDA interaction/meeting experience for scientific advice is required.
- Writing skill and IND/NDA eCTD module preparation experience is required.
What we look for in our people:
- Highly motivated self-starter with an entrepreneurial spirit and commitment to personal and career development.
- Desire to work in a quickly changing and fast-paced growing business.
- Unrelenting dedication to delivering results and a desire to shape the strategic goals of the business. Willing to roll up your sleeves to get the job done.
- Ability to overcome ambiguity and challenge the status quo
- Manage multiple programs with competing and aggressive timelines, prioritize activities, and work independently.
written and oral communication skills; experienced presenter of key messages to
broad audiences including Senior Stakeholders