Head of Regulatory Affairs

2 weeks ago

Cambridge, Massachusetts, United States ONO PHARMA USA Full time

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

The role acts as a liaison with Health Authorities and serves as the Regulatory Project Leader for various initiatives at different stages of development. Responsibilities include:

Strategic Leadership

  • Provides expert regulatory guidance for assigned drug development projects, leveraging extensive knowledge to inform project teams on regulatory obligations to facilitate successful global development plans.

Project Management

  • Oversees the planning, preparation, and submission of intricate regulatory documents to support project objectives.
  • Directs cross-functional teams to ensure high-quality submissions, including INDs, NDAs/BLAs, meeting requests, briefing documents, orphan applications, and pediatric study plans, while offering strategic direction and mentorship to team members.

Operational Excellence

  • Leads the creation of comprehensive meeting packages, driving meeting strategies and team readiness.
  • Contributes to policy development and the globalization of operational processes.
  • Maintains up-to-date knowledge of US, EU, and ICH regulatory standards and proactively communicates changes in the regulatory landscape throughout the organization.

Innovation and Adaptation

  • Stays informed about evolving regulations and health authority actions, applying insights to shape regulatory project strategies.

Talent Development

  • Acts as a strategic regulatory authority for assigned drug development programs, utilizing extensive expertise to guide project teams on regulatory requirements.
  • Leads cross-functional teams to produce high-quality submissions and fosters staff engagement and development.

Relationship Management

  • Serves as the primary contact with Health Authorities for designated products.
  • Negotiates with Health Authorities and aids in interpreting their feedback.
  • Builds and nurtures relationships with internal and external stakeholders, integrating regulatory and drug development knowledge to enhance collaboration and achieve project and organizational goals.

Qualifications

  • Bachelor's degree in life sciences; advanced degree preferred.

Experience Requirements

  • Minimum of 8 years of relevant regulatory experience.
  • Experience with NDA/BLA submissions is essential.
  • Proven track record in developing regulatory strategies for products aimed at treating chronic and severe, life-threatening diseases.

Technical Proficiencies

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

Cognitive Abilities

  • Strategic thinker capable of interpreting complex regulations and applying them effectively throughout the product development lifecycle.
  • Ability to synthesize information quickly, assess and mitigate risks, and prioritize tasks across multiple projects.
  • Strong analytical and problem-solving skills.

Communication Skills

  • Exceptional verbal and written communication skills, with the ability to engage effectively with Health Authorities and diverse peer groups.
  • Capability to negotiate innovative development and registration pathways for rare diseases.
  • Demonstrated success in interacting within a dynamic and culturally diverse work environment, both remotely and in person.

Additional Information

  • Ability to formulate global regulatory strategies for products targeting chronic and severe, life-threatening diseases.

Work Environment

  • Generally sedentary work, but may require standing, walking, and organizing to maintain a tidy workspace.

Travel Requirements

  • Occasional attendance at meetings and relevant professional conferences may be required, with travel up to 15% of the time, subject to business needs.

To succeed in this role, an individual must be able to fulfill each essential duty satisfactorily. The qualifications listed above represent the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

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