Sr. Director, Regulatory Affairs

1 month ago

Boston, United States The Steely Group Full time
The Senior Director, Regulatory Affairs will serve as a Health Authority liaison and Regulatory Project Leader for multiple projects in various stages of development.  This individual will establish and communicate regulatory strategies and manage regulatory activities for compounds through all phases of development, post-approval, and for the life-cycle of the products. May have line management and people development responsibilities, and will play a key role in the development and implementation of regulatory policies within the organization.

Responsibilities and Duties:
  • 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. 
  • Manage the planning, preparation, and submission of complex regulatory dossiers in support of project goals.  Lead cross-functional teams to deliver high quality submissions, e.g., INDs, NDAs/BLAs, meeting requests and briefing documents, orphan applications, pediatric study plans, etc.
  • Serve as the primary liaison with Health Authorities for assigned products.  Lead preparation of high quality meeting packages, drive meeting strategy and team preparation. Negotiate with Health Authorities; aid in the interpretation of Health Authority feedback.
  • Build relationships with internal and external stakeholders and integrate regulatory and drug development knowledge to facilitate ways of working and achievement of project and company goals. 
  • Provide strategic direction and mentoring to staff, foster staff engagement and development.
  • Contribute to the generation of policies and to the globalization of work processes.
  • Maintain knowledge of US, EU and ICH regulatory requirements and guidelines and anticipate, assess and communicate changes in regulatory framework throughout the organization, as relevant.
  • May be required to perform other duties, as assigned.

Requirements / Qualifications:
  • This position requires a bachelor’s degree in the life sciences, or the equivalent in work experience. Advanced degrees are preferable.
  • Must possess a minimum of 10 years of relevant regulatory experience; advanced degrees highly desirable.
  • Oncology regulatory project leadership experience required
  • NDA/BLA experience preferred
  • Experience managing staff
  • Demonstrated ability to interact successfully in a dynamic and culturally diverse workplace, remotely and in person.  
  • Experience developing global regulatory strategies for products intended to treat chronic diseases and products intended to treat severe, life-threatening diseases.  
  • Ability to negotiate novel development and registration pathways for rare diseases.
  • Ability to quickly integrate information, think strategically, define and mitigate risk, and prioritize activities among multiple projects.  Work with a sense of urgency to maintain important schedules and timelines. .
  • 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. 
  • Strategic thinker, able to interpret complex regulations and apply them appropriately, throughout the product development lifecycle.
  • Strong analytical skills and problem-solving capabilities.
  • Experience with document management systems, RIMS
  • Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
  • As our client is a global company, this role may be required to attend and participate in business meetings in person or via conference call, that will be scheduled in the evening or early morning.
  • This role requires the incumbent to occasionally attend meetings at company sites, and relevant professional conferences. Travel will be scheduled based upon the needs of the business, up to 15% of the time.

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