Hybrid Associate Director, Regulatory Affairs

Posted 7 hours ago

Apply now

About the role

  • Associate Director leading Global Regulatory Affairs and Clinical Safety for pharmaceutical partnerships. Coordinating cross-functional activities to maintain regulatory obligations and compliance.

Responsibilities

  • Lead GRACS Integration/Transition teams for assigned deals: recruit and onboard team members; facilitate planning and milestone alignment, risk/issue identification, and progress tracking against deal implementation project plans following the GRACS Business Development Execution Playbooks and related tools
  • Work closely across functions to support the migration of content from/to the partner in support of in-scope systems and tools for GRACS, working closely with vendor and IT to execute the task effectively and within the agreed timelines
  • Coordinate with Corporate Business Development, Company Research Labs, Global Alliance Management (MGAM), Integration Management Office (IMO), and GRACS BD to understand agreement obligations and timelines. Align across the division's functions
  • Serve as point of contact for ongoing operational alliance-related questions within GRACS scope; coordinate responses and escalate issues appropriately
  • Support the ongoing maintenance of deal-related documentation, updates, and communications in the appropriate systems; prepare concise status summaries for GRACS leadership as needed
  • Oversee deal integration, transition, and partnership-related risk and issues to investigate and identify causes, gather and process relevant information, generate possible solutions, make recommendations, and/or resolve the problem and direct the resolution of complex business problems through a documented Escalation pathway for the deal
  • Support adherence to GRACS collaborative frameworks and share best practices; contribute to continuous improvement by capturing lessons learned and proposing enhancements to execution tools
  • Work across Business Development Execution Operations to drive projects to improve operations of the team based on lessons learned and outcomes from risk/issue resolution efforts

Requirements

  • Bachelor's Degree preferably in technical, business, or science
  • At least 8 years in the pharmaceutical industry with at least 5 years in Regulatory/Pharmacovigilance Function or Alliance Management
  • Understanding of regulatory and clinical processes for pharmaceutical products, vaccines, and/or biologic products
  • Strong proficiency in English, including verbal, reading, and writing skills
  • Strong virtual and in-person collaboration
  • Demonstrated facilitation and leadership skills
  • Clear communicator and goal-oriented
  • Comfort and experience in building and presenting effective slide presentations with audiences at all levels of the organization
  • Independent thinker and worker
  • Highly organized, motivated, and detail-oriented while still able to keep an overall "big picture" view of projects and strategies
  • Demonstrated analytical and data management skills
  • Experience pulling together abstract milestones and data into a centralized management report
  • Demonstrated ability to lead cross-functional teams and facilitate cross-functional meetings to achieve a purpose
  • Strong, demonstrated project management capabilities and skills
  • Ability to collaborate and manage multiple projects at various stages of the process simultaneously
  • Ability to communicate messages clearly and concisely, both verbally and in writing
  • Experience with change management concepts and execution
  • Strong proficiency with generating content using all MS Office tools, including but not limited to Word, Excel, Power-Point and SharePoint
  • Some experience creating and modifying MS Teams and MS Project or related tools to manage project timelines and collaboration
  • Demonstrated sensitivity and knowledge of Diversity and Inclusion principles

Benefits

  • Flexible Work Arrangements: Hybrid
  • Employee Status: Regular
  • Travel Requirements: Flexible

Job title

Associate Director, Regulatory Affairs

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

Report this job

See something inaccurate? Let us know and we'll update the listing.

Report job