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Director, Regulatory Affairs

3 months ago

Cambridge, United States ONO PHARMA USA Full time

**This role requires 3 days onsite in Cambridge**


Role that serves as a Health Authority liaison and Regulatory Project Leader for multiple projects in various stages of development. The role:


Serves as a strategic regulatory leader for assigned drug development programs and uses extensive knowledge to advise project teams on regulatory requirements to drive successful global development strategies.


  • Manages the planning, preparation, and submission of complex regulatory dossiers in support of project goals.
  • Leads cross-functional teams to deliver high quality submissions, e.g., INDs, NDAs/BLAs, meeting requests and briefing documents, orphan applications, pediatric study plans, etc. and provides strategic direction and mentoring to staff, foster staff engagement and development.

Planning and Execution

  • Manages the planning, preparation, and submission of complex regulatory dossiers in support of project goals.

Operation and Improvement

  • Leads preparation of high-quality meeting packages, drives meeting strategy and team preparation.
  • Contributes to the generation of policies and to the globalization of work processes.
  • Maintains knowledge of US, EU and ICH regulatory requirements and guidelines and anticipates, assesses, and communicates changes in regulatory framework throughout the organization, as relevant.

Innovation

  • Keeps abreast of changing regulations and health authority actions, applies knowledge to devise regulatory project strategy.

Talent Development and Organization Growth

  • Serves as a strategic regulatory leader for assigned drug development programs and uses extensive knowledge to advise project teams on regulatory requirements to drive successful global development strategies.
  • Leads cross-functional teams to deliver high quality submissions, e.g., INDs, NDAs/BLAs, meeting requests and briefing documents, orphan applications, pediatric study plans, etc. and provides strategic direction and mentoring to staff, foster staff engagement and development.

External/Internal Relationship

  • Serves as the primary liaison with Health Authorities for assigned products.
  • Negotiates with Health Authorities, aid in the interpretation of Health Authority feedback.
  • Builds relationships with internal and external stakeholders and integrates regulatory and drug development knowledge to facilitate ways of working and achievement of project and company goals.

Educational Requirements

  • Bachelor’s degree in life sciences, advanced degree preferred.

Experience

  • Must possess 8 years of relevant regulatory experience.
  • Must have NDA/BLA experience.
  • Experience developing regulatory strategies for products intended to treat chronic diseases and products intended to treat severe, life-threatening diseases.

Technical Skills

  • Experience with document management systems, RIMS
  • Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).

Cognitive Skills

  • Strategic thinker, able to interpret complex regulations and apply them appropriately, throughout the product development lifecycle,
  • Ability to quickly integrate information, define and mitigate risk, and prioritize activities among multiple projects.
  • Strong analytical skills and problem-solving capabilities.

Language/Interpersonal Skills

  • Must have excellent communication skills (verbal and written). Must be able to effectively communicate with Health Authorities and with peer group members from diverse cultural backgrounds.
  • Ability to negotiate novel development and registration pathways for rare diseases.
  • Demonstrated ability to interact successfully in a dynamic and culturally diverse workplace, remotely and in person.

Other

  • Ability to develop global regulatory strategies for products intended to treat chronic diseases and products intended to treat severe, life-threatening diseases.

Physical Demands

  • Work is generally sedentary in nature, but may require standing, walking, grasping, to maintain a neat and organized work environment,

Work Environment

  • The noise level in the work environment is usually quiet.

Business Travel

  • The incumbent may occasionally attend meetings at Ono sites, and relevant professional conferences. Travel could be scheduled based upon the needs of the business, up to 15% of the time, barring pandemic restrictions.


To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function of this role. (US Only)