Regulatory Affairs Business Development Manager - RABDM 0130MC#001

Regulatory Affairs Business Development Manager

Duration: 12 Months

Must Haves:

• At least 12 years in the pharmaceutical industry with at least 5 years in Regulatory/Pharmacovigilance Function, Alliance, or Business Development.
• Minimum BS Degree, preferably in technical, business, or science.

Required Experience:

• Ability to influence and operate effectively in an ambiguous, rapidly changing environment while maintaining quality and compliance.
• Proven skills in project management, leadership, strategic thinking, and problem-solving in a deadline-driven environment.
• Strong virtual and in-person collaboration skills.
• Demonstrated facilitation and leadership capabilities.
• Clear communicator and goal-oriented professional.
• Experience creating and delivering effective presentations for various audience levels.
• Independent thinker with strong organizational and detail-oriented skills, while maintaining a big-picture view of projects and strategies.
• Strong analytical and data management skills; experience consolidating milestones and data into centralized reports.
• Ability to lead cross-functional teams and facilitate meetings to achieve objectives.
• Strong project management capabilities, with experience managing multiple projects simultaneously.
• Effective written and verbal communication skills.
• Knowledge of change management concepts and execution.
• Proficiency in MS Office tools (Word, Excel, PowerPoint, SharePoint) and experience with MS Teams, MS Project, or related tools for project collaboration.

Brief Description of Position:

• Under minimal guidance, manage business processes and activities related to Global Regulatory Affairs and Clinical Safety (GRACS) Business Development Execution.
• Coordinate various GRACS functional areas to ensure the implementation and maintenance of regulatory activities associated with assigned Business Development (BD) Agreements.
• Manage agreements related to divestitures, mergers/acquisitions, in-licensing, out-licensing, collaborations, public-private partnerships, distribution, co-marketing, and authorized generics.
• Facilitate processes, communication, and governance to ensure GRACS contractual obligations are met while maintaining regulatory compliance.
• Collaborate with Corporate Business Development, Global Alliance Management, and the Integration Management Office to understand partner agreements and objectives throughout the post-signing lifecycle.
• Establish and lead the GRACS Integration or Transition Team, recruiting and onboarding team members upon completion of due diligence.
• Lead discussions with GRACS subject matter experts (SMEs) to identify gaps, risks, and track progress, ensuring leadership is informed.
• Understand contractual requirements and work closely with Corporate Business Development and Alliance Management teams.
• Assess and resolve GRACS integration-related challenges, generate solutions, and direct the resolution of complex business problems.
• Develop frameworks and best practices for collaboration with business partners and facilitate knowledge transfer between GRACS teams.
• Provide training on partner relationship skills, collaboration, communication, and tools.
• Drive continuous improvement of Business Development processes pre- and post-execution, ensuring effective collaboration between GRACS functions and business partners.
• Serve as the point of contact for alliance management issues related to ongoing GRACS activities when maintaining long-term business relationships.