Executive Director, Regulatory Affairs Liaison

Job Description

Our Regulatory Affairs team in General Medicine advances medical innovation to patients by establishing clear timely and robust strategies for registration enabled by engagement with global health authorities. We work across functions and geographies to advance development programs and maintain licensure for the General Medicine portfolio worldwide. We seek a leader with a growth mindset demonstrated by intellectual curiosity and the ability to navigate complex regulatory challenges with rigor and professionalism.

Position Description:

The Executive Director Regulatory Affairs Liaison reports to the Vice President (VP) General Medicine and is accountable for defining and executing global regulatory strategy for assigned ophthalmology programs. This role provides strategic oversight across ophthalmology programs in the General Medicine Therapeutic Area ensuring regulatory objectives are aligned with development evidence-generation and commercialization priorities. The Executive Director leads and develops a team of Global Regulatory Leads (GRLs) sets standards for regulatory excellence across multiple complex programs and serves as an authoritative regulatory expert in ophthalmology drug development. As a senior regulatory leader the individual represents the function on enterprise governance bodies and in external engagements with major health authorities and is regarded as an internal regulatory subject matter expert.

Key Responsibilities:

• Oversee the development and implementation of global regulatory strategy for ophthalmology and retinal disease programs for multiple indications to minimize time to approval and optimize labeling.

• Provide oversight for direct reports and support them to function as the single global point of accountability for assigned projects partnering closely with international regulatory colleagues and engaging global health authorities to deliver on Company priorities.

• Oversee strategy review and approve key regulatory deliverables including submissions external communications (e.g. press releases) background packages local registration study protocols and labeling to ensure accuracy and consistency.

• Lead manage and review the performance of direct reports including oversight of regulatory strategy resource allocation for respective projects and staff development.

• Represent the company at external initiatives regulatory authority meetings and internal committees as required.

• Provide strategic input into regulatory due diligence activities for licensing candidate review.

Minimum Education Requirements:

• B.S./M.S. in biological science or related discipline with a minimum of 12 years of relevant drug development experience with a majority in regulatory affairs.

• M.D./Ph.D. or PharmD. with a minimum of 9 years relevant drug development experience with at least 7 years in regulatory.

Required Experience and Skills:

• Demonstrated ability to deliver results independently while remaining aligned with leadership.

• Demonstrated scientific knowledge effective communication and thorough familiarity with worldwide regulatory agencies.

• Demonstrated success in securing original NDA/BLA approvals.

• Outstanding interpersonal communication and negotiation skills.

• Demonstrated leadership attributes including experience building and leading high-performing teams or projects.

Preferred Experience and Skills:

• Regulatory experience in retinal disease and ophthalmology programs.

• People management experience.

• Substantial experience with both small and large molecule development programs.

• Extensive experience in U.S. and international regulatory affairs with prior experience as a Global Regulatory Lead.

Additional Information:

• Extent of Travel: 10%

• Geographical Scope: U.S. and global regulatory responsibility

Required Skills:

Preferred Skills:

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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 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

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 employees 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 include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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