Regulatory Affairs Director

3 weeks ago

Cambridge, Massachusetts, United States ONO PHARMA USA Full time

As a key member of project teams at ONO PHARMA USA, the Associate Director, Regulatory Affairs will serve as a Health Authority liaison and establish regulatory strategies for development programs. This role is responsible for coordinating timelines, generating, and submitting complex regulatory dossiers.

Key Responsibilities

  • Manages the planning, preparation, and submission of regulatory dossiers in support of project goals, including developing and maintaining submission plans and timelines.
  • Serves as the Regional Regulatory Lead (RRL) for assigned drug development programs.
  • Leads cross-functional teams to deliver high-quality submissions, such as INDs, NDAs/BLAs, meeting requests, and briefing documents.

Planning and Execution

  • Develops and maintains submission plans and timelines to ensure regulatory dossier readiness.

Operation and Improvement

  • Keeps abreast of changing regulations, guidance documents, and technical/scientific developments relevant to projects, ensuring all work is compliant with regulatory requirements and company policies.
  • Contributes to the generation of SOPs and work processes relevant to the regulatory scope of work.

Innovation

  • Develops regulatory strategies for assigned projects, with supervisor oversight, in the region.

Talent Development and Organization Growth

  • Accountable for regulatory dossier generation, content, and timeline, and strategy in the region.
  • Maintains knowledge of regulatory requirements and anticipates, assesses, and communicates changes in regulatory information to project teams.

External/Internal Relationship

  • Serves as the primary liaison with Health Authorities for assigned products, ensuring all communications with regulators are properly documented.

Educational Requirements

  • Bachelor's degree in life sciences.

Experience

  • Must possess at least six (6) years of relevant regulatory experience and eight (8) years of experience within the pharmaceutical or biotechnology industry.

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) and be able to effectively communicate with Health Authorities and 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

  • Demonstrate strategic regulatory leadership for assigned projects in the region (US).

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 PHARMA USA 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.

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