Director of Regulatory Affairs managing compliance for Luxury Brand Partners in beauty industry. Collaborating with product development and marketing teams while ensuring regulatory standards are met.
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
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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