About Dermavant:


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.


Position:


The Associate Director of Regulatory Operations will be responsible for supporting the Veeva Regulatory Information Management system. This person will work closely with team members and senior management across the Regulatory, Clinical, Nonclinical, CMC, Quality, and IT functions to ensure that critical regulatory documentation is properly created and maintained. This will include documentation associated with product development, correspondence with global health authorities, and documentation related to marketed products. Ensuring compliance with FDA and ICH regulations and guidelines is critical, and thus knowledge of the QA, Regulatory, and Compliance environments is critical. This is a hands-on role requiring an in-depth knowledge of research and development documents and processes. The role will evolve with the growth of Dermavant Sciences, and there will be opportunities for continued professional growth.

This successful candidate will be responsible for supporting document management services for innovative medicines that address unmet medical needs and bring significant value to patients in diverse therapeutic areas. A successful candidate will maintain focus on corporate goals while responding to the needs of global project teams in a highly dynamic, fast-moving environment.

Responsibilities:

  • Supporting the implementation, deployment, document migration, and maintenance of a Regulatory Information Management system.
  • Responsible for supporting efficient integration of legacy documents of acquired assets, including classifying, indexing, records management, quality review, and eCTD compliance, to facilitate their use in future applications of new global development plans.
  • Serves as a subject matter expert on existing GxP IT systems related to clinical data, document management, Regulatory Information Management and Training.
  • Defines processes and fulfills business administration duties related to administration, change control, maintenance and operations of Regulatory Information Management systems.
  • Assesses the impact of regulatory, clinical, and quality software changes and upgrades.
  • Works with vendors to ensure a smooth transition for system upgrades and new configuration.
  • Responsible for supervision of or leading training and troubleshooting user issues within the document management system.
  • Ensures GMP documentation is uploaded into the electronic document repository and filed with the appropriate metadata
  • Communicate critical document issues and potential mitigation strategies to key stakeholders in the global project teams and global regulatory affairs management.
  • Maintain up-to-date knowledge on international and domestic regulatory technical requirements.
  • Initiate and contribute to the development of policies, procedures and SOPs in alignment with GxPs, Guidance, and corporate objectives.
  • Interact efficiently and independently to plan and coordinate the migration of documents from multiple legacy systems of development programs with internal staff and external consultants/vendors to adhere to company objectives and timelines.
  • Contribute to the planning for future growth and expansion of document management services.
  • May be asked to forecast resourcing needs to accommodate workload.
  • May be responsible for direct or indirect reports.

Qualifications:

  • Current knowledge of GxP regulations and ICH and FDA Guidance’s
  • Working knowledge of current systems to support efficient document management, including RIMS, Quality and eTMF systems
  • Ability to blend analytical and critical-thinking skills to enable data-driven, strategically oriented review and repurpose of legacy regulatory documents.
  • Minimum of 7 years of experience performing Regulatory Operations support.
  • Minimum of 7 years of experience of working in a controlled and validated document management system.
  • Ability to Pre-publish PFD documents to industry standards (hyperlink and bookmark)
  • Ability to recognize development document types and understand their life cycle across development.
  • Knowledge of, and experience with, the processes associated with clinical data management and organization of documents into submission ready formats
  • Knowledge of, and experience in, electronic submissions (eCTD), document management, and training management
  • Knowledge of, and experience with, GxP and CFR regulations and system validation
  • Strong computer skills, with demonstrated experience and ability in electronic document management and quality systems (e.g., PleaseReview, Veeva Vault Systems, RIMs, Microsoft Office suite)
  • Working knowledge of Veeva Vault and commercial publishing systems (eg, Lorenz Docubridge, Liquent, Accenture Octagon, etc.) a plus
  • Strong written and oral communication skills
  • Proven experience engaging in multiple initiatives simultaneously
  • Acts with integrity, entrepreneurial spirit, ownership mentality, and a commitment to excellence
  • Excellent organizational skills and ability to work on multiple projects with tight timelines
  • Excellent verbal and written communication skills
  • Strong interpersonal skills and desire to work with matrixed project teams
  • Effective negotiation and decision making skills
  • Results-oriented individuals with a strong work ethic and ability to complete projects with minimal oversight; track record of involvement with successful IND, CTA, NDA, and/or BLA submissions
  • Maintain strong working relationships across Development to promote a services-oriented environment within this department.
  • Working with or managing vendors at some level may be 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 time lines, prioritize activities, and work independently.
  • Excellent written and oral communication skills; experienced presenter of key messages to broad audiences including Senior Stakeholders

This position has been filled. Would you like to see our other open positions?