Executive Director Regulatory Affairs Strategy

4 weeks ago

Bedford, United States Ocular Therapeutix Full time

Summary/Scope:

A multifaceted Regulatory Affairs Team Leader role. Will be a key member of regulatory leadership to ensure the development, implementation and alignment of US/ ex US regulatory strategy across projects within Retina / Ophthalmology. Will represent the regulatory affairs function as a Core Member of Project Teams and be responsible for developing and implementing regulatory strategy (US and/or global) to achieve regulatory approvals and competitive product labels.

Core Responsibilities:

* With VP Regulatory Affairs, lead the development and maintenance of Regulatory Affairs practices and procedures at Ocular Therapeutix
* Responsible for preparation and compilation of domestic and international product submissions. This may include, but is not limited to: INDs, NDAs, MAAs, NDS and global CTAs. This also includes all lifecycle maintenance filings necessary to support these applications (e.g. CMC supplements/notifications, 2253 submissions, annual reports, efficacy supplements and safety reporting).
* Co-develop and direct implementation of global regulatory strategy for assigned projects, along with company representatives and other Regulatory and CMC staff.
* Guide regulatory staff in the development and implementation of regulatory strategy, submission strategy, and lifecycle management to ensure alignment with project team objectives (US and/or global).
* Communicate FDA feedback, regulatory strategies and plans to management, cross-functional teams and any partners/collaborators to establish alignment.
* Act as a strategic partner in the core governance & program teams within the company.
* Maintain knowledge of US competitive landscape, regulatory environment, regulations and guidances.
* Assesses the impact of new health authority guidances and provides insight and recommendations on Regulatory Policy & Intelligence
* Responsible for creation and maintenance of Regulatory Development Plans and submission strategies to achieve regulatory approvals that meet project needs.
* Lead the preparation of high quality regulatory dossiers ensuring compliance with regulatory requirements
* Ensure agency establishment registrations and device/drug listings are completed on time.
* Assist with the preparation and compilation of regulatory information requested during regulatory inspections.
* Support domestic and international field corrective actions and adverse event reporting, when necessary

Other/Related Responsibilities:

* Responsible for leading, managing, mentoring, and developing regulatory staff.
* Direct responses to Health Authority inquiries as needed.
* Review product and process documentation for assigned projects to ensure compliance with regulatory dossiers.
* Responsible for the development and maintenance of regulatory procedures to assure consistent, efficient and compliant regulatory processes.
* Provide regulatory research information as requested.
* Develop, review and secure necessary approvals on key documents before major regulatory submissions (US and/or global).
* May participate in Business Development/Strategic Alliances efforts.
* Lead or participate in regulatory sub-teams, FDA and other Health Authority meetings for a project, as required.
* Prepare management and team for FDA and other Health Authority meetings, as required.
* Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidances

Key Requirements:

* Solid scientific background, minimum Bachelors in scientific discipline. Advanced scientific degree, M.S. PharmD, PhD., M.D., preferred
* Minimum of 15 years pharmaceutical industry experience, of which 10 years in US and global regulatory affairs leading strategy development and strategy implementation in a cross-functional project team setting. Regulatory experience in multiple phases of drug development with deep expertise in Retina/Ophthalmology preferred.
* Demonstrated experience in strategic planning, preparing and leading IND/NDA submissions
* In depth knowledge of current US and global regulations and guidances essential as they relate to the overall global regulatory strategy
* Results driven and team-orientated with the ability to influence outcomes as necessary skills in the regulatory environment.

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