Director, Regulatory Affairs

Global Regulatory Affairs And Clinical Safety Business Development Execution Director

Under the minimal guidance of the Senior Director, Business Development Execution, the incumbent manages and is responsible for the business process and related activities associated with Global Regulatory Affairs and Clinical Safety (GRACS) Business Development Execution. The primary function includes coordinating various GRACS functional areas, to ensure implementation and maintenance of regulatory activities associated with assigned Company Business Development (BD) Agreements. These agreements include but are not limited to divestitures, mergers / acquisitions, in-licensing, out-licensing, collaborations, public private partnerships, distribution, co-marketing, and authorized generic agreements. Facilitates the processes, communications, and governance to ensure GRACS contractual obligations and commitments are met while maintaining regulatory compliance.

Work closely with the Corporate Business Development, our Company's Research & Development Division Global Alliance Management (MGAM), Integration Management Office (IMO) and GRACS Business Development to understand the partner agreements and the goals of those agreements throughout the lifecycle post signing.

Responsible for establishing the GRACS Integration or Transition Team (comprised of functional Subject Matter Expert (SME)) through the recruiting and onboarding integration team members upon completion of the due diligence and understanding of the contract execution requirements for the deal.

Following the GRACS Business Development Operating Model, performs all responsibilities of the GRACS Business Development Execution Lead (or Integration Lead for Acquisitions / Mergers / Collaboration or Transition Lead for divestitures) including facilitation of discussions with GRACS SME execution team to identify gaps and risks, track progress and coordinate ongoing updates of progress to ensure GRACS Leadership is informed as needed. Responsible for understanding contracts and working closely with the Corporate Business Development and our Company's Research & Development Division Alliance Management Teams.

Assess GRACS Integration related problem situations to 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.

Ensure adherence to the established common network framework for GRACS functional areas to understand / evaluate business partner operations, establish guidelines for working together and leverage differences to create value, share best practices and deliver activities to drive knowledge transfer between GRACS team members. Provide training as necessary on successful partner relationship skills including process, collaboration, communication, and tools.

Develop the functional alliance relationship to support effective business deal execution, engage partners and GRACS applicable personnel to explore the potential challenges of working together, examine differences, develop shared protocols for managing those differences, and establish mechanisms for their day-to-day work.

Work closely with the Mature Deals and Operations team to define, establish, and drive continuous improvement of the Business Process for the pre and post execution phases of Business Development Agreements with focus on how the different GRACS functions and business partners collaborate.

Specific to opportunities where an ongoing relationship is maintained with the business partner, the incumbent will be responsible for serving as the point of contact for all alliance management issues related to ongoing GRACS activities.

The Director may also have people management responsibilities related to oversight of team members in supporting opportunities in a similar manner as described above. Additionally, the incumbent will assume the responsibilities for employee development and management consistent with Company Leadership and Diversity and Inclusion principles.

Education :

• BS Degree preferably in technical, business or science.

Required Experience :

Desired Experience :

Required Skills :

Accountability, Biopharmaceutical Industry, Business Processes, Communication, Cross-Functional Teamwork, Decision Making, Detail-Oriented, Diversity and Inclusion (D&I), Divestitures, Employee Training Programs, EU Legislation, In Licensing, Mentorship, Mergers and Acquisitions (M&A), Negotiation, Out Licensing, People Leadership, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Experience, Regulatory Intelligence {+ 4 more}

Preferred Skills :

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only :

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The salary range for this role is $169,700.00 - $267,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits